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Competing interests | The authors declare that they have no competing interests. | PMC10082980 | ||
References | PMC10082980 | |||
Purpose | PPH, hemorrhoids, prolapse, anal pain | HEMORRHOIDS, PROLAPSE, COMPLICATIONS, HAND SWELLING | The purpose of this study was to explore the effect of electroacupuncture (EA) at Baliao point on short-term complications, such as anal pain and swelling, after procedure for prolapse and hemorrhoids (PPH) in patients with mixed hemorrhoids. | PMC10115677 |
Methods | A total of 124 eligible patients undergoing PPH surgery were included in this study and randomly divided into a control group ( | PMC10115677 | ||
Results | tenesmus, urinary retention | The visual analogue scale (VAS) scores of EA group at 8, 24, 48, and 72 h after operation were significantly lower than those of control group. The anal distension scores at 8, 48, and 72 h after operation were also significantly lower than those of control group. The number of postoperative analgesic drug administration per patient was also significantly lower in the EA group. The incidence of urinary retention and tenesmus in EA group was significantly lower than that in control group within the first day after surgery. | PMC10115677 | |
Conclusion | swelling, hemorrhoids, prolapse, anal pain, urinary retention | HEMORRHOIDS, PROLAPSE | EA treatment at the Baliao point can alleviate short-term anal pain and anal swelling after the procedure for prolapse and hemorrhoids, reduce the incidence of urinary retention, and decrease the use of postoperative analgesic drugs. | PMC10115677 |
Trial registration | This study was approved and registered by the Chinese Clinical Trial Center, Registration number: ChiCTR2100043519, Registration time: February 21, 2021 ( | PMC10115677 | ||
Keywords | PMC10115677 | |||
Introduction | PPH, hemorrhoids, defecation disorders | MIXED HEMORRHOIDS, DISEASE, DISEASES, HEMORRHOIDS | Mixed hemorrhoids are a common disease that afflicts people all over the world, and PPH is a common operation for the treatment of mixed hemorrhoids [The Baliao point (BL31–BL34) is a traditional Chinese acupuncture point with a long history. They are divided into four pairs, namely Shang liao (BL31), Ci liao (BL32), Zhong liao (BL33), and Xia liao (BL34), with a total of eight acupuncture points (Fig. Anatomical position of Baliao pointIn China, some scholars have initially explored the effect of EA at Baliao point on anorectal diseases and postoperative recovery after anorectal surgery. It had been reported that acupuncture at Baliao point can promote anorectal motility and improve functional defecation disorders [The purpose of this study is to further explore the effect of EA at Baliao point on the improvement of postoperative pelvic floor function in patients who underwent PPH surgery through a single disease in moderate sample size with more comprehensive observation indicators. | PMC10115677 |
Patients and methods | PPH | This study was an investigator blinded randomized pilot study. Since the lack of objective, prospective studies on the effects of EA at Baliao point on patients after PPH, the actual sample size calculations could not be performed. And this study was conducted in accordance with the ethical, moral, and scientific principles stipulated in the Helsinki Declaration and Guideline for good clinical practice. In addition, this study was approved and registered by the Chinese Clinical Trial Center, Registration number: ChiCTR2100043519, Registration time: February 21, 2021. | PMC10115677 | |
Participants | hemorrhoids | HEMORRHOIDS | A total of 261 patients with mixed hemorrhoids who underwent PPH surgery in Shanghai Fifth People’s Hospital from March 2021 to March 2022 were identified with 128 patients were excluded. The most common reason for exclusion was meeting our exclusion criteria. Those who met the exclusion criteria were 121 (Table Reasons for patient exclusionTotal CONSORT 2010 flow diagram | PMC10115677 |
Inclusion criteria | hemorrhoids | INTERNAL HEMORRHOIDS, HEMORRHOIDS | (1) patients with severe internal hemorrhoids or mixed hemorrhoids with surgical indications; (2) age between 18 and 70 years old; (3) no history of anorectal surgery; (4) patients gave informed consent to participate in this study. | PMC10115677 |
Exclusion criteria | mental disorders, perianal infection, hernia, diabetes | PROSTATIC HYPERPLASIA, PERIANAL INFECTION, DISEASES, DIABETES | (1) patients with mental disorders; (2) those who have poor compliance and do not accept this clinical trial; (3) pregnant women, menstrual, and lactating women; (4) combined with perianal infection and other benign anorectal diseases; (5) patients with prostatic hyperplasia, diabetes, and other underlying diseases that may affect the postoperative observation indexes; (6) history of previous inguinal hernia surgery, urethral tension-free suspension surgery, and other surgery that may affect pelvic floor function; (7) patients who require additional use of analgesia pump after surgery. | PMC10115677 |
Randomization | Patients were randomized to receive either the control group or the EA group using the sealed envelope method by means of a one-to-one treatment allocation. The randomization was carried out by a clinician not involved in this study. Treatment assignments were generated using a randomized numerical table method. Envelopes were numbered sequentially, opaque. The outside serial number envelope was in line with the patient's visit sequence. The physician provided the enrolled patient with a sealed envelope labeled with the serial number. The patient then opened the sealed envelope containing the patient’s random group information. The primary investigator knew nothing about patient assignment until the study and data analysis were complete. | PMC10115677 | ||
Procedure | PPH, hemorrhoids, bleeding, pain | STERILE, BLEEDING, HEMORRHOIDS | Preoperative preparation: All patients were given glycerol enema 2 h before surgery to empty the stool.Surgical procedure of PPH: Spinal anesthesia was used for anesthesia. After successful anesthesia, the patient took the jackknife position. The surgical field was routinely disinfected with iodophor, and sterile towels and sheets were laid. The anal dilator was inserted into the anus to expose the hemorrhoids and dentate line. Loop suture of the rectal mucosa with a 2–0 absorbable suture at 3.0 cm from the dentate line. One stitch was sutured with silk in the direction of 3 o’clock and 9 o’clock of the anus. The stapler was inserted, and the mushroom head purse was ligated. The traction wire was drawn out from the side hole, tightened the stapler, held it for 1 min after firing, and slowly withdrew the stapler after loosening. Checked the anastomosis and sutured with 3–0 absorbable suture at the bleeding place to stop the bleeding. Vaseline gauze and hemostatic gauze were used to compress the wound, and the operation was completed.Postoperative analgesic measures: After operation, ketorolac tromethamine 30 mg, q12h, was given intravenously for analgesia.When the patient’s pain is significantly relieved, it will be discontinued. The dose will be increased if necessary. All increased doses of analgesics will be recorded.Severe pain will be treated with an opioid (Bucinnazine Hydrochloride Injection).Operation process of EA at Baliao point: The bilateral Ci liao (BL32) and bilateral Zhong liao (BL33) were selected as acupuncture points (a total of 4 acupuncture points on both sides). Alcohol cotton balls were used to disinfect the acupoints, and 0.30 × 75 mm needles were used for acupuncture with a depth of about 3 cm. The needle was connected to the CMNS6-1 needle stimulator, and EA was stimulated for 20 min (the setting conditions were continuous wave, 40 Hz, level 2 intensity). And the acupuncture therapies were performed by senior attending physicians of the Department of Traditional Chinese Medicine of the Fifth People's Hospital of Shanghai. | PMC10115677 |
Outcomes | bleeding, seizures, Postoperative defecation, tenesmus, Postoperative pain, diarrhea, postoperative anal distension, pain, constipation, infection, impaired urination, anal pain, Urination, Postoperative anal distension | ADVERSE REACTIONS, BLEEDING, ADVERSE EVENT, INFECTION, URINATION DISORDER | Main outcome measures: The primary endpoint was the VAS scores and the anal distension scores at 8, 24, 48, and 72 h after operation. Secondary endpoints were urination, time to first defecation after surgery, feeling of tenesmus, use of postoperative analgesic drugs, and other related indexes which were observed after surgery.Postoperative pain: VAS was used to evaluate the pain of surgical incision in patients at 8 h, 24 h, 48 h, and 72 h after the operation.Postoperative anal distension: According to the following criteria, postoperative anal distension was divided into 4 grades, grade I (0 points): no anal distension; grade II (2 points): occasional seizures or mild symptoms; grade III (4 points): frequent, severe symptoms, affecting life, can be relieved after rest and treatment; grade IV (6 points): frequent, affecting daily life, and cannot be relieved even after rest and treatment.Postoperative analgesic drug use: the administration times and additional use of ketorolac tromethamine were recorded for each patient. In addition, every use of opioid (Bucinnazine Hydrochloride Injection) should be recorded.Urination 24 h after operation: The evaluation criteria were as follows: grade I (0 points): urination was unobstructed without urination disorder; grade II (2 points): slightly impaired urination, able to urinate without treatment; grade III (4 points): able to urinate on their own, but with less urine volume, abdominal distension and other related signs and symptoms, requiring conservative treatment; grade IV (6 points): no urine is excreted and catheterization is required.Postoperative defecation: The patient’s first defecation time, daily defecation frequency, and feeling of urgency after surgery were recorded.Adverse events occurred during the experiment, including but not limited to bleeding, infection, needle sickness, and unplanned reoperations which were recorded.One month after the operation, the patients were followed by telephone to self-observe the following indicators: whether there was repeated anal pain; whether there was an anal bulge that was difficult to relieve; whether there was tenesmus; whether there was repeated constipation and diarrhea; and other adverse reactions or discomfort symptoms. | PMC10115677 |
Statistical analysis | Data were analyzed using GraphPad 9.0 software. Measurement data were expressed as mean ± standard deviation ( | PMC10115677 | ||
Results | PMC10115677 | |||
Subject demographics | hemorrhoids | HEMORRHOIDS | From March 2021 to March 2022, a total of 124 patients with hemorrhoids who met the inclusion criteria and underwent PPH surgery were collected in Shanghai Fifth People’s Hospital. The patients were randomly assigned to the control group (Characteristics of the patients | PMC10115677 |
Primary outcomes | urinary retention, Defecation, urination disorder, pain | URINATION DISORDER | The VAS scores of the patients in the EA group at 8, 24, 48, and 72 h after the operation was significantly lower than that of the control group (Fig. VAS pain score within 72 h after operation. Note: *Score of anal distension within 72 h after operation. Note: *Analgesic drug use after operationThe urination score 24 h after the operation in the EA group was significantly lower than that in the control group, indicating that EA at Baliao point can effectively relieve the urination disorder and urinary retention that occurred after PPH. There was no significant difference in the frequency of defecation and the characteristics of stool between the two groups on the 1st, 2nd, and 3rd days after surgery (Table Defecation and urination after operation | PMC10115677 |
Postoperative adverse events | bleeding, diarrhea, Postoperative adverse, tenesmus, hematochezia, postoperative bleeding, constipation, infection, anal pain | BLEEDING, HEMATOCHEZIA, POSTOPERATIVE BLEEDING, INFECTION, POSTOPERATIVE WOUND INFECTION | One case of postoperative bleeding, one case of postoperative surgical incision infection and one case of reoperation due to bleeding occurred in the control group, and one case of surgical incision infection occurred in the EA group. There was no statistically significant difference between the two groups in postoperative bleeding, postoperative wound infection, and reoperation rates (Table Postoperative adverse eventsThe telephone follow-up results at 1 month after operation showed that there was no hematochezia in two groups. A small number of patients in the two groups had recurrent anal pain or distension, tenesmus, constipation, or diarrhea, but there was no significant difference between the two groups. It was worth noting that some patients in both groups complained that they could not completely empty feces. The number of patients in the control group was slightly more than that in the EA group, but the difference was not statistically significant (Table Follow-up outcomes at 1 month after operation | PMC10115677 |
Discussion | bleeding, diarrhea, tenesmus, hemorrhoids, postoperative urinary retention, Acupuncture, postoperative urination disorder, ’ anal pain, pain, postoperative infection, postoperative bleeding, chronic anal pain, constipation, PPH, urinary retention | BLEEDING, HEMORRHOIDS, POSTOPERATIVE COMPLICATION, POSTOPERATIVE BLEEDING, POSTOPERATIVE INFECTION, SURGICAL COMPLICATIONS, SECONDARY, COMPLICATIONS | PPH surgery is a good choice for the treatment of hemorrhoids, which has the advantages of short operation time, low incidence of surgical complications, rapid postoperative recovery, and reliable surgical effect [Acupuncture and moxibustion is a kind of treatment in traditional Chinese medicine, which has been increasingly used for perioperative treatment in recent years [A total of 124 patients with hemorrhoids who underwent PPH at Shanghai Fifth People’s Hospital were included in our study. The results showed that EA at Baliao could significantly relieve patients’ anal pain, anal distension, and postoperative urination disorder within 3 days after operation, which was consistent with the previous clinical results on EA at Baliao point. This intervention could have significant clinical relevance since post-operative pain and anal distension are common complications after PPH and can negatively impact patient recovery and quality of life. By providing a non-pharmacological alternative for pain relief, EA at Baliao point may offer a valuable addition to the current standard of care for patients undergoing PPH. It is worth mentioning that the acupoints selected in our study are secondary liao and middle liao, which are different from those reported previously. In addition to PPH, spinal anesthesia will also lead to short-term complications such as local pain and urinary retention; our EA treatment may also has therapeutic effect on local pain and postoperative urinary retention caused by spinal anesthesia and promotes the overall recovery of patients after PPH. Interestingly, there was no statistically significant difference in stool frequency and stool characteristics between the EA group and the control group within 3 days after the operation, suggesting that the effect of EA at Baliao point on defecation function and stool formation needs further research and exploration.Postoperative complications such as postoperative infection and urinary retention occurred in both groups of patients. There was no significant difference in the incidence of postoperative infection between the two groups. While the incidence of urinary retention in the control group was significantly higher than that in the EA group, indicating that EA at Baliao point can promote the recovery of bladder function in patients, promote urine excretion, and avoid the use of catheters after PPH surgery. In addition, one patient in the control group developed severe postoperative bleeding and underwent a second operation to stop the bleeding. In the EA group, there was no postoperative bleeding or reoperation patients in the EA group. We believe that this difference may be caused by accidental factors and is not related to the EA at Baliao point.One-month follow-up results showed that some patients in both groups had symptoms of chronic anal pain, anal bulge, tenesmus, constipation, or diarrhea, but there was no significant difference between the two groups. In both groups, some patients complained that they could not completely empty the feces during defecation, which is a common problem after PPH. The number of patients in the EA group suffering from this problem was slightly less than that in the control group, but the difference was not statistically significant. And this study also has some limitations. Firstly, whether EA at Baliao point can improve the problem of inability to completely empty feces in patients after PPH requires further research. Secondly, there is no objective laboratory index for the patients’ subjective feeling of heaving and pain. How to avoid strong subjectivity and objectively and correctly evaluate the degree of anal distension and pain after PPH needs further research and demonstration. Thirdly, although some studies have shown that the physiological mechanism of acupuncture is related to purinergic signaling, the endorphins theory [ | PMC10115677 |
Author contribution | Yuankun Cai and Lifeng Gong designed the study. Jiamen Shen and Xiecheng Zhou shared in the data analysis, interpretation, and writing and drafting of the manuscript. Huipeng Wang and Tao Ye contributed to data collation. Xin Wang and Wenjie Chen analyzed and interpreted the data. Jiaying Zhao contributed to the interpretation of data and revision of the manuscript. All the authors contributed to this article and approved the submitted version. All the authors critically revised the manuscripts. All the authors gave the final approval of the version to be published. | PMC10115677 | ||
Funding | This study was supported by grants from the Special Project of integrated traditional Chinese and Western medicine of Shanghai (No. ZHYY-ZXYJHZX-202007). | PMC10115677 | ||
Data availability | The data used to support the findings of this study are available from the corresponding author upon request. The data are not publicly available due to privacy or ethical restrictions. | PMC10115677 | ||
Declarations | PMC10115677 | |||
Conflict of interest | The authors declare no competing interests. | PMC10115677 | ||
References | PMC10115677 | |||
Background | Innovative mobile health (mHealth) interventions can improve maternal knowledge, thereby supporting national efforts to reduce preventable maternal and child mortality in South Africa. Studies have documented a potential role for mobile video content to support perinatal health messaging, enhance maternal satisfaction, and overcome literacy barriers. Short, animated storytelling (SAS) is an innovative, emerging approach to mHealth messaging. | PMC10612008 | ||
Objective | We aimed to measure the effect of SAS videos on maternal knowledge and user satisfaction for mothers enrolled in antenatal care programs at 2 public health facilities in the Tshwane District of South Africa. | PMC10612008 | ||
Methods | We used a randomized controlled trial with a nested evaluation of user satisfaction. Participants were randomized 1:1 into Standard-of-Care (SOC) Control, and SAS Intervention groups. The intervention videos were delivered through WhatsApp, and 1 month later, participants responded to telephone surveys assessing their knowledge. The intervention group then participated in a nested evaluation of user satisfaction. | PMC10612008 | ||
Results | SECONDARY | We surveyed 204 participants. Of them, 49.5% (101/204) were aged between 25 and 34 years. Almost all participants self-identified as Black, with the majority (190/204, 93.2%) having completed secondary school. The mean overall knowledge score was 21.92/28. We observed a slight increase of 0.28 (95% uncertainty interval [UI] –0.58 to 1.16) in the overall knowledge score in the intervention arm. We found that those with secondary education or above scored higher than those with only primary education by 2.24 (95% UI 0.76-4.01). Participants aged 35 years or older also scored higher than the youngest age group (18-24 years) by 1.83 (95% CI 0.39-3.33). Finally, the nested user satisfaction evaluation revealed high maternal satisfaction (4.71/5) with the SAS video series. | PMC10612008 | |
Conclusions | While the SAS videos resulted in high user satisfaction, measured knowledge gains were small within a participant population that was already receiving perinatal health messages through antenatal clinics. The higher knowledge scores observed in older participants with higher education levels suggest that boosting maternal knowledge in younger mothers with lower education levels should continue to be a public health priority in South Africa. Given the high maternal satisfaction among the SAS video-users in this study, policy makers should consider integrating similar approaches into existing, broad-reaching perinatal health programs, such as MomConnect, to boost satisfaction and potentially enhance maternal engagement. While previous studies have shown the promise of animated video health education, most of this research has been conducted in high-income countries. More research in underresourced settings is urgently needed, especially as access to mobile technology increases in the Global South. Future studies should explore the effect of SAS videos on maternal knowledge in hard-to-reach populations with limited access to antenatal care, although real-world logistical challenges persist when implementing studies in underresourced South African populations. | PMC10612008 | ||
Trial Registration | Pan African Clinical Trials Registry PACTR202203673222680; https://tinyurl.com/362cpuny | PMC10612008 | ||
Introduction | Despite documented reductions in maternal and child mortality during the era of the Millennium Development Goals [SMS text message–based dissemination was originally chosen to make MomConnect universally accessible to mothers with basic (nonsmart) cell phones [Short, animated storytelling (SAS) videos constitute a promising new approach to public health education that emerged during the COVID-19 pandemic. The development of this approach was catalyzed by the necessity for rapid, accessible global communication of critical health messages [Animation has been shown to support patient education [In this study, named the “Amandla Mama” study [The specific aims of this study are: (1) to measure the effect of watching the Amandla Mama SAS video series on knowledge of maternal and neonatal health, and (2) to measure user satisfaction associated with the Amandla Mama SAS video series. | PMC10612008 | ||
Methods | PMC10612008 | |||
Intervention | With input from local mothers and community health workers in South Africa, we developed the Amandla Mama intervention, a collection of 10 short, animated storytelling videos focused on critical perinatal health topics. During the content creation process, research partners at the Clinton Health Access Initiative in South Africa gathered formative feedback from women attending antenatal clinic visits. These expectant mothers shared their thoughts on a collection of prototypes, originally developed by our coinvestigator (MA) and the Digital Medic health education program, based in South Africa and the United States [Topics included in the Amandla Mama short, animated storytelling (SAS) video intervention. | PMC10612008 | ||
Trial Design | We used a randomized controlled trial with a nested user satisfaction evaluation to measure the effect of the Amandla Mama videos on maternal knowledge and to assess maternal satisfaction. Participants were randomly assigned to either the SAS Intervention group or the Standard-of-Care (SOC) Control group. SOC in South Africa includes regular antenatal counseling at the local clinic, according to the National Department of Health’s Guidelines for Maternity Care in South Africa [ | PMC10612008 | ||
Study Setting | This study took place in the City of Tshwane Metropolitan District of Gauteng, South Africa. The Tshwane Health District is situated in the northern region of Gauteng Province. In 2019, the Tshwane District had a population of more than 3 million people, with a population density of 515/km | PMC10612008 | ||
Recruitment and Informed Consent | RECRUITMENT | Participants were recruited at the clinics while they waited for their antenatal appointments. As such, this was a convenience sample, recruited consecutively by research team members affiliated with the Clinton Health Access Initiative in South Africa. Members of the research team described the trial to mothers and gained informed consent for participation in the study from mothers who expressed an interest in taking part. During recruitment, participants were notified that their participation in the study was voluntary and that they could withdraw at any time without any threat or punitive measures. They were also notified that they would receive airtime vouchers to compensate them for their time and expenses incurred by participating in the study. | PMC10612008 | |
Participants and Eligibility Criteria | Eligible participants were expectant mothers accessing routine antenatal health care services at the 2 facilities [Flow diagram for the Amandla Mama Study. | PMC10612008 | ||
Measures | Sociodemographic data were collected verbally from enrolled participants and immediately entered into a shared spreadsheet by our local research team. Since the trial involved testing and implementing a new intervention and we found no appropriate perinatal knowledge assessments that had been validated within this study population, the research team designed a survey consisting of 28 knowledge questions based on the intervention (Table S1 in | PMC10612008 | ||
Maternal satisfaction items. For each question, participants indicated how satisfied they were with the videos they saw on a scale of score 1-5, with 1=not at all satisfied and 5=extremely satisfied. |
Were the videos easy to understand? (1=not easy at all, 5=very easy)Do you think the videos were useful? (1=not useful at all, 5=very useful)How easy was it for you to download the videos? (1=not easy at all, 5=very easy)How fast was it to download the videos? (1=very slow, 5=very fast)How easy was it for you to watch the videos? (1=not easy at all, 5=very easy)How easy was it for you to identify with the characters in the animated videos? (1=not easy at all, 5=very easy)How likely are you to follow the advice offered in the videos? (1=not likely at all, 5=very likely)How strongly do you feel that the videos gave you important information in a short time? (1=not at all, 5=very strongly) | PMC10612008 | ||
Outcomes | SECONDARY | The primary outcome in this study was maternal knowledge. The secondary outcome was maternal satisfaction, defined as the mean response of all participants in the SAS Intervention group for each of the 8 satisfaction items. | PMC10612008 | |
Assignment of Interventions, Allocation, and Blinding | Participants were randomly assigned 1:1 to either the SAS Intervention group or the SOC Control group. A computer-generated randomization sequence was used to assign participants to their respective groups. To implement the randomization, a table with the randomized sequence was created, and participants were added sequentially as they were enrolled in the study. The randomization sequence was masked and applied to the table by a member of the research team who was not involved in recruiting or interviewing participants. In this way, participants were allocated equally to either the control or intervention groups without the recruiters or interviewers being aware of the group to which individual participants had been assigned. In this way, both the recruiters and interviewers remained blinded to the allocation throughout the study. After the knowledge survey had been administered, the interviewers were unblinded and able to administer the maternal satisfaction questionnaire, focused on experiences using the videos, to the SAS Intervention mothers. | PMC10612008 | ||
Participant Time Line | Upon enrolling in the study, participants in the intervention group received the video intervention through WhatsApp, delivered to their cellphones. One month later, all of the participants were contacted telephonically by the research team to respond to the surveys. Following the unblinding of the interviewers, participants in the intervention group were asked if they had watched the videos after receiving them, and participants in the control group were asked if they had been shown any short, animated maternal health videos on the phones of others. These questions allowed us to detect any contamination in the control group and also facilitated an analysis based on the intention to treat. | PMC10612008 | ||
Sample Size | We determined the sample size for this trial based on our primary outcome, maternal knowledge. We used a significance level of .05 (We hypothesized that, at the 2-week data collection time point, the mean score of participants in the control group on the knowledge questionnaire would be 43% (12 points out of 28 points in the survey), while the mean score of the intervention group on this questionnaire would be 61% (17 out of 28 points). This would constitute an 18% absolute increase and a 1.41-times relative increase. We calculated a sample size of n=140 for each study arm, then added 50% to account for participant dropouts and loss to follow-up. This brought our sample size to n=210 for the intervention group and n=210 for the control group. Thus, we estimated a total sample size of N=420 participants for the trial. We carried out these sample size calculations on G-Power 3.1.9.6, based on the difference between 2 independent proportions, using a | PMC10612008 | ||
Statistical Analysis | REGRESSION | We compared the distribution of demographic variables between the trial arms with the chi-square test or the exact Fisher test, as appropriate. Regarding the primary outcome, the sum of the scores is a discrete count, but with a bounded value at the total number of questions (28 knowledge questions). Thus, we modeled the total score using a Beta-Binomial distribution, that is, score∼BB (n=28,μ,σ), which accounts for potential overdispersion and the bounded property of the distribution. Compared to the empirical distribution of the total score, the distribution fitted better than the common count distributions, including Poisson and Negative Binomial distribution (Figure S1 in There were 11 individuals with missing data in one of the 28 knowledge questions; thus, we used multiple imputations to impute the missing values, conducted analyses on 100 imputed samples and reported the pooled analyses. We conducted multivariable regression analyses to explore the effect on the knowledge scores of the SAS Intervention group based on intention to treat. The model was adjusted for age, sex, education level, living area, working status, and whether the mother was enrolled in the MomConnect program. The models were fitted in a Bayesian inference framework using the statistical program R (version 4.0.2; The R Foundation). We reported the 95% uncertainty interval (UI) of the mean differences between the covariates by drawing 1000 samples from the posterior distribution and calculating the quantiles of the mean difference, which is nμ for the BB distribution. (The code for analyses is publicly available at GitHub [ | PMC10612008 | |
Access to the Full Protocol, Participant-Level Data, and Statistical Code | The protocol for this trial was published as open access in June 2022 [ | PMC10612008 | ||
Ethical Considerations | Ethical approval for the study was granted by the Pharma-Ethics Independent Research Ethics Committee, the Tshwane Health Research and Ethics Committee, and the Scientific Research Ethics Committee of the Clinton Health Access Initiative. We also registered this study on the National Health Research Database (GP202111071). The study researchers were trained in good clinical practice through accredited health research ethics training programs. Written informed consent was obtained from all participants. | PMC10612008 | ||
Results | PMC10612008 | |||
Knowledge Outcomes | Our participants achieved a mean overall score of 21.92 (78.3%) on the knowledge questionnaire (Table S1 in Changes in overall knowledge scores by baseline variable and intervention exposure. | PMC10612008 | ||
Maternal Satisfaction Outcomes | Finally, we present the results of our nested maternal satisfaction evaluation in Maternal satisfaction items describing the experience of using short, animated storytelling (SAS) videos. | PMC10612008 | ||
Discussion | PMC10612008 | |||
Principal Results | SECONDARY | In this study, we observed slight gains in maternal knowledge with large uncertainty after a single exposure to a series of 10 short, animated storytelling videos delivered through WhatsApp to expectant mothers in the Tshwane District of Gauteng Province, South Africa. Mothers with secondary level education or higher demonstrated higher scores than those with primary education level, and participants aged 35 years or older scored higher than the youngest age group (18-24 years). Results of our nested maternal satisfaction evaluation revealed very high overall satisfaction with the experience of using the SAS video series. | PMC10612008 | |
Limitations | Our initial expectation of a larger effect size (5 points increase) led to an underpowered sample size to detect smaller gains in knowledge. Our participants were all receiving routine antenatal care, where they were likely hearing similar perinatal health messages to the ones included in the SAS videos. Other significant limitations of this study were the real-world challenges associated with testing a mHealth intervention in a setting where internet access can be unreliable, the turnover of cell phones and contact numbers is high, and mothers may be sharing cell phones with their partners. This led to a larger-than-anticipated loss to follow-up in this study and negatively impacted our ability to detect an effect of the SAS intervention. We also did not collect data on the parity of this study’s participants. Finally, we were constrained by the method of measuring knowledge in this study. Due to literacy barriers, the knowledge survey had to be administered verbally by our research assistants. The inability to administer the knowledge surveys without human intervention (ie, digitally) meant that we could not exclude the possibility that interviewers collecting survey data may have inadvertently helped the participants. This potential limitation is supported by the relatively high knowledge scores we observed across all participants. | PMC10612008 | ||
Comparisons With Previous Work | In a recent meta-analytic review, Feeley et al [ | PMC10612008 | ||
Conclusions | The high maternal satisfaction related to the use of SAS videos suggests that there may be a role for SAS videos in augmenting widely adopted interventions like MomConnect. Especially as internet access and smartphone penetration increase across South Africa, there may be a growing role for innovative approaches that encourage engagement with perinatal health services through high-satisfaction, easily scalable add-ons, like SAS videos.While policy makers in South Africa continue to promote readily scalable interventions like MomConnect, they should consider enhancing such programs through the addition of content-aligned interventions like the Amandla Mama SAS video series to enhance user satisfaction and potentially boost engagement with perinatal health messages. Furthermore, for mothers who lack access to maternity clinics, the provision of MomConnect and SAS videos may be an effective way to transmit critical perinatal health messages to hard-to-reach communities in ways that overcome education and literacy barriers. Because of the “glocalizable” character designs used in the Amandla Mama series, these videos could also easily and cost-effectively be adapted for other language groups in South Africa and other countries. Health promotion agencies in South Africa might even consider translating and dubbing short, animated video content to make it accessible for all South African mothers—a potentially powerful step toward overcoming both language and literacy barriers to maternal health education.The authors would like to acknowledge the mothers who participated in this study. Thank you for your time and for sharing your insights with us. We wish to thank our talented animator, Janine Van Schoor, our colleagues at the Clinton Health Access Initiative in South Africa who supported and oversaw the implementation of this study, particularly our research assistants, Rendani Mufhadi, Lerato Molwane, and Tshegofatso Hlahaswane, the Digital Medic South Africa Program for working with us to develop the video prototypes, and the organization that funded this work: the German Aerospace Centre.Conflicts of Interest: None declared.Empirical density distribution of the total knowledge score and Maternal Knowledge Survey.Perinatal mental health.Nutrition in pregnancy.Kangaroo Mother Care.Recognizing pregnancy.Alcohol avoidance.Benefits of breastfeeding.Danger signs in the newborn period.Complementary feeding.Immunizations.Danger signs in pregnancy.CONSORT-eHEALTH checklist (V 1.6.1). | PMC10612008 | ||
Abbreviations | mobile healthshort, animated storytellingstandard-of-careuncertainty interval | PMC10612008 | ||
Data Availability | The data collected as part of this study are available upon request from the corresponding author MA. The data are not publicly available, as we wish to protect the privacy of the expectant mothers who agreed to participate. The entire video series is available in | PMC10612008 | ||
Background | INTRAUTERINE GROWTH RETARDATION | The authors have declared that no competing interests exist.Micronutrient-fortified balanced energy-protein (BEP) supplements are promising interventions to prevent intrauterine growth retardation in low- and middle-income countries. On the other hand, one concern with blanket prenatal supplementation programs using energy-dense supplements is that they could lead to more maternal and/or infant overweight. However, evidence is lacking on the potential effect of BEP on maternal and offspring body composition. This study evaluates the effects of micronutrient-fortified BEP supplementation during pregnancy on body composition of mothers and their newborns in rural Burkina Faso. | PMC10406330 | |
Methods and findings | The MISAME-III study is an open label individually randomized controlled trial where pregnant women ( | PMC10406330 | ||
Conclusions | Micronutrient-fortified BEP supplementation during pregnancy can increase maternal and newborn FFMI, without significant effects on FMI. | PMC10406330 | ||
Trial registration | ClinicalTrials.gov with identifier In a sub-study nested under the MISAME-III trial, an individually randomised controlled efficacy trial in rural Burkina Faso, Carl Lachat and colleagues investigate the effect of prenatal micronutrient-fortified balanced energy-protein supplementation on body composition of mothers and their newborns. | PMC10406330 | ||
Author summary | PMC10406330 | |||
Why was this study done? | overweight | INTRAUTERINE GROWTH RETARDATION | Prenatal multimicronutrient-fortified balanced energy-protein (BEP) supplementation is a promising nutritional intervention to alleviate the high burden of intrauterine growth retardation, including low birth weight and small-for-gestational age, in low- and middle-income countries.On the other hand, one concern with blanket prenatal supplementation programs using energy-dense supplements is that they could lead to more infant and/or maternal overweight, as observed with consumption of ultra-processed foods in high-income countries.However, only few studies evaluated the impact of prenatal BEP supplementation on the body composition of mothers and their newborns using a robust RCT design and a direct body composition assessment. | PMC10406330 |
What did the researchers do and find? | In a sub-study nested under the MISAME-III trial, an individually randomized controlled efficacy trial in rural Burkina Faso, we evaluated the effects of prenatal micronutrient-fortified BEP supplementation on body composition of mothers and their newborns.Our trial indicates that micronutrient-fortified BEP supplementation during pregnancy can improve maternal and newborn fat-free mass index (FFMI) without altering maternal fat-mass index (FMI). | PMC10406330 | ||
What do these findings mean? | adiposity | ADIPOSITY | Our findings that prenatal BEP improved FFMI without increases in FMI address the possible concern that prenatal BEP could lead to excess adiposity and associated long-term health risks.Future research is required to investigate the long-term effects of prenatal BEP on body composition of older infants and children. | PMC10406330 |
Data Availability | The informed consent form does not allow sharing of personal data outside the research team. Request to access data need to be directed to the ethics committee of Ghent University Hospital through ethisch. | PMC10406330 | ||
Introduction | overweight, LBW | PRETERM DELIVERY, FETAL GROWTH RESTRICTION | Low birth weight (LBW; i.e., born <2,500 g) is a marker of suboptimal fetal growth and development caused by preterm delivery (i.e., gestational duration <37 weeks) and/or fetal growth restriction, which results in a small-for-gestational age (SGA) newborn (i.e., birth weight below the tenth percentile of a reference group of newborns with the same gestational age). LBW is associated with a significantly higher neonatal mortality risk that varies between a 2-fold risk increment for SGA neonates, a 7-fold risk for preterm newborns, and up to a 15-fold risk increase when children are born both preterm and SGA [Prenatal nutritional supplementation is one key strategy to prevent LBW. Systematic review and meta-analysis of relevant studies showed that prenatal multimicronutrient (MMN) fortified balanced energy-protein (BEP) supplementation reduces the risk of SGA (relative risk (RR): 0.79; 95% confidence interval (CI): 0.69, 0.90) [One concern with blanket prenatal supplementation programs using energy-dense supplements, such as LNS, is that it could lead to more infant and/or maternal overweight, as observed with consumption of ultra-processed foods in high-income countries [ | PMC10406330 |
Methods | PMC10406330 | |||
Ethics statement | The MISAME-III study protocol was approved by the ethics committee of Centre Muraz in Burkina Faso (N°2018–22/MS/SG/CM/CEI) and Ghent University Hospital in Belgium (B670201734334). Participant mothers provided their written consent for participation after an information session detailing the study, voluntary participation, and withdrawal. The trial is registered at | PMC10406330 | ||
Study design and intervention | The MISAME-III study is an individually randomized 2 × 2 factorial trial evaluating the efficacy of a combination of micronutrient-fortified BEP and iron-folic acid (IFA) supplementation, as compared to IFA supplementation alone, during pregnancy and during lactation on various maternal, newborn and infant outcomes. In this sub-study nested in the main MISAME-III trial, we evaluate the effect of prenatal micronutrient-fortified BEP supplementation on maternal and newborn body composition.The MISAME-III parent study has been described in detail previously [Women were randomly assigned to receive either daily BEP and IFA supplementation (intervention) or IFA alone (control). The BEP supplement was a large-quantity LNS in the form of an energy-dense peanut paste fortified with multiple micronutrients [ | PMC10406330 | ||
Study participants | The prenatal phase of the main MISAME-III study was conducted between the first enrollment on 30 October 2019 and the last delivery on 7 August 2021. Pregnant women ( | PMC10406330 | ||
Stable isotope administration and saliva sample collection | EVENT | The body composition of mothers and infants was assessed using the stable isotope dilution technique with deuterium oxide (DIn the event that both the mother and her newborn were selected (The D | PMC10406330 | |
Study outcomes and measurement | The primary outcomes of interest of the study are fat-mass index (FMI) and fat-free mass index (FFMI) (i.e., mass divided by squared height) in mothers and newborns. Secondary study outcomes are %FFM and %FM of total body weight in mothers and newborns; maternal BMI; and newborn length-for-age, weight-for-age, and weight-for-length z-scores. A sample size of 440 newborns per study arm (880 in total) was required to detect an effect size (Cohen’s d) of 0.2 on FFMI and 0.4 for an interaction effect between supplementation and maternal low versus high BMI (<21 versus ≥21 kg/mBody composition assessment of mothers and newborns was conducted within 3 weeks postpartum (mean ± SD days after delivery: 18.2 ± 3.96). Newborn weight was measured to the nearest 10 g using a Seca 384 scale, and length was measured to the nearest 1 mm using a Seca 416 length board. Maternal weight was measured to the nearest 100 g using a Seca 876 scale and height was measured to the nearest 1 mm using a ShorrBoard. All measurements were taken in duplicate and a third measurement was taken when there was a large discrepancy between the duplicate measurements. We used the average of the 2 closest anthropometric measurements for analysis. Anthropometric indices of length-for-age, weight-for-age, and weight-for-length | PMC10406330 | ||
Statistical analysis | REGRESSION | Data analyses were conducted using Stata 17.1 (Statacorp, Texas, USA) and a two-sided statistical significance was considered at alpha <0.05. Descriptive statistics are presented as means ± SD for the continuous variables and as frequencies (%) for the categorical variables. Study outcomes were checked for normality of distribution using visual inspection of histograms and Q-Q plots of the outcome values and their residual terms.Unadjusted and adjusted group differences in body composition indices were estimated by fitting linear regression models. All models included health center and randomization block as covariates to account for the study design [Besides evaluating any effect modification of BEP by maternal BMI and MUAC at study enrollment, we explored the presence of effect modification by other covariates. For this purpose, we tested an interaction effect of the intervention and each factor on FFMI and FMI. Effect modification by a subgroup factor was considered in the presence of a statistically significant interaction ( | PMC10406330 | |
Results | From the 880 newborns considered for the body composition sub-study, we analyzed data from 720 (81.8%) newborns ( | PMC10406330 | ||
Trial flow diagram of the MISAME-III body composition sub-study. | BC, body composition; MISAME, MIcronutriments pour la SAnté de la Mère et de l’Enfant. | PMC10406330 | ||
Discussion | lean mass accretion, adiposity, FM | ADIPOSITY | Our study found that prenatal BEP led to a higher maternal and newborn FFMI without significant effects on FMI. The positive effect of prenatal BEP on maternal FFMI was found to be larger among mothers with a better nutritional status at baseline (i.e., BMI ≥21.0 kg/mOur results are in contrast to those from the MISAME-II trial conducted in the same health district between 2006 and 2008. MISAME-II found elevated cord blood leptin concentration, indicating larger newborn FM accretion [A number of trials have evaluated the effects of prenatal LNS on maternal and newborn outcomes [Various possible explanations can be forwarded for our finding that prenatal BEP in mothers and their newborns led to FFM accretion rather than FM accretion. First, the composition of the BEP supplement used could possibly influence the balance between FFM and FM tissue accretions. Diets and supplements containing animal-source proteins, especially those from dairy products, support lean mass accretion better than diets or supplements containing only plant-based protein sources [Subgroup analyses showed that prenatal BEP was more efficacious in increasing maternal FFM index in the women from food secure households or with a more adequate energy balance (i.e., baseline BMI ≥21.0 kg/mThe observed effects of prenatal BEP on newborn FFMI can be seen in relation to the subsequent modest effect of prenatal BEP on linear growth achieved at 6 months of age (0.11 z-score; 95% CI: 0.01, 0.21; A major strength of our study was the direct measurement of body composition using the deuterium dilution method, which enables robust assessment that can be implemented at scale in a rural field setting. We were also able to achieve a high adherence to both the BEP and IFA supplements through daily home visits by community-based study workers who observed supplement intake. A dietary intake survey conducted in a subsample of the study participants also ruled out any substitution effect of the BEP on usual dietary patterns [The study has several limitations that need to be addressed. About 18% of the newborn outcome data was missing mainly due to saliva samples not being collected or unreadable identification numbers on cryotubes, whereas we anticipated a 10% loss when designing the study. However, the occurrence of missing data was not specific to any of the study group and maternal and household characteristics were comparable between study groups. Therefore, we argue that the missing data are unlikely to have biased group comparisons. Maternal body composition using the deuterium dilution method was not measured at baseline. As such, we were only able to consider baseline adjustment in our models for proxy variables of body composition such as BMI and arm fat index. Lastly, having follow-up body composition measurements would have revealed whether observed effects are sustained in the long term.In conclusion, our study demonstrated that prenatal BEP supplementation has positive effects on newborn and maternal FFM accretion without significant alteration of FMI. The absence of any effects of BEP on fat mass accretion in both newborn and mother addresses the possible concern that prenatal BEP would lead to excess adiposity and associated long-term health risks. | PMC10406330 |
Supporting information | PMC10406330 | |||
Nutritional values of the ready-to-use supplementary food for pregnant women. | (DOCX)Click here for additional data file. | PMC10406330 | ||
Comparison of participants between the MISAME-III study and the body composition sub-studies. | (DOCX)Click here for additional data file. | PMC10406330 | ||
Effect of prenatal micronutrient-fortified BEP supplementation on maternal and newborn body composition using CACE estimates. | (DOCX)Click here for additional data file. | PMC10406330 | ||
Relationship between newborn and maternal FFMI and FMI and birth anthropometry. | (DOCX)Click here for additional data file. | PMC10406330 | ||
Treatment effect on maternal and newborn FFMI across the distribution of maternal BMI at baseline. | The estimated difference in FFMI between the intervention and control groups is plotted as a function of the percentiles of maternal BMI. The zero line indicates no efficacy of BEP. The positive y values indicate a higher FFMI in the intervention group, and the negative y values indicate a lower FFMI, with upper and lower 95% confidence bands. BMI, body mass index; FFMI, fat-free mass index.(TIF)Click here for additional data file. | PMC10406330 | ||
Treatment effect on maternal and newborn FMI across the distribution of maternal BMI at baseline. | The estimated difference in FMI between the intervention and control groups is plotted as a function of the percentiles of maternal BMI. The zero line indicates no efficacy of BEP. The positive y values indicate a higher FMI in the intervention group, and the negative y values indicate a lower FMI, with upper and lower 95% confidence bands. BMI, body mass index; FFI, fat-mass index.(TIF)Click here for additional data file. | PMC10406330 | ||
Locally weighted scatterplot smoothing plotting the relationship between newborn and maternal FFMI. | REGRESSION | Linear regression model was fitted to estimate the beta and 95% CIs for the relationship between newborn and maternal FFMI.(TIF)Click here for additional data file. | PMC10406330 | |
CONSORT checklist of the manuscript. | (PDF)Click here for additional data file. | PMC10406330 | ||
Impact of a prenatal and postnatal balanced energy protein supplement on birth size and postnatal child growth in Burkina Faso. | Dougoumato II | (PDF)Click here for additional data file.The authors thank all the women from Boni, Dohoun, Karaba, Dougoumato II, Koumbia, and Kari who participated in the study, the data collection team and Henri Somé from AFRICSanté. We thank Nutriset (France) for donating the BEP supplements. | PMC10406330 | |
Abbreviations | balanced energy-proteinbody mass indexconfidence intervalcomplier average causal effectdeuterium oxideestimated average requirementfat-free mass indexfat-free mass as percentage of total body weightfat-mass indexfat-mass as percentage of total body weightFourier-transformed infrarediron-folic acidlow birth weightlipid-based nutrient supplementmean differenceMIcronutriments pour la SAnté de la Mère et de l’Enfantmultimicronutrient tabletmid-upper arm circumferencerelative riskstandard deviationsmall-for-gestational age, TBW, total body water | PMC10406330 | ||
References | PMC10406330 | |||
Objectives | osteopenia | AGE-RELATED MACULAR DEGENERATION, OSTEOPENIA | This study aimed to analyze the relationship between age-related macular degeneration and osteopenia, defined as decreased bone mineral density, in the Polish population. | PMC10586687 |
Methods | osteopenia, AMD-1 | AGE-RELATED MACULAR DEGENERATION, OSTEOPENIA, DECREASED BONE MINERAL DENSITY | Participants were derived from the population-based Bialystok PLUS Study. Randomized individuals were stratified into two groups, those with age-related macular degeneration (AMD-1 group) or without age-related macular degeneration (AMD-0 group). Using a cutoff value of −1.0 to identify low bone mass, participants with femoral bone mineral density T-scores above −1.0 were assigned to the normal reference, and those with T-scores below −1.0 were assigned to the osteopenia category. Among 436 Caucasian participants aged 50–80 years (252 women, 184 men), the prevalence of age-related macular degeneration was 9.9% in women and 12.0% in men. Decreased bone mineral density based on T-scores was observed in 36.9% of women and in 18.9% of men. Significant differences in femoral bone mineral density between the AMD-0 and AMD-1 groups were detected only in men (mean difference [95% confidence interval] = 0.11 (0.02; 0.13); p = 0.012 for femoral bone mineral density, and 0.73 [0.015; 0.94]; p = 0.011 for the femoral T-score). No associations were observed between bone mineral density and age-related macular degeneration in women. | PMC10586687 |
Conclusion | AGE-RELATED MACULAR DEGENERATION | Decreased femoral bone mineral density may be associated with a higher risk of age-related macular degeneration in men, but a causal link remains unclear. | PMC10586687 | |
Data Availability | All relevant data are available on Harvard Dataverse: | PMC10586687 | ||
Introduction | AMD, blindness, vision loss, osteoporosis, trauma | AGE-RELATED MACULAR DEGENERATION, OSTEOPOROSIS, BLINDNESS | Age-related macular degeneration (AMD) is the primary cause of irreversible blindness in developed countries [AMD primarily affects the macula, leading to vision loss in the central 15 to 20 degrees of the visual field, often in both eyes. Not surprisingly, patients with AMD frequently sustain injuries, including skeletal trauma and fragility fractures [In 2010, the prevalence of osteoporosis among 50- to 84-year-old women from the European Union was estimated at 21%, compared with only 6% among men [We could identify only two published studies revealing an epidemiological link between osteoporosis and AMD [ | PMC10586687 |
Materials and methods | PMC10586687 | |||
Study design and participants | endocrine diseases | ENDOCRINE DISEASES, POLAND | The study included participants of the Bialystok PLUS Study, who were 50–80 years of age. The Bialystok PLUS Study was a prospective, population-based, cohort study in which the determinants and occurrence of cardiovascular, neurological, ophthalmic, psychiatric, musculoskeletal, and endocrine diseases were analyzed among residents of the city of Bialystok (Northeastern Poland). It had a fully randomized design. The aims, methodology, and protocol of the study have been described in detail elsewhere [ | PMC10586687 |
Bone mineral density measurement | osteoporosis | OSTEOPOROSIS | The analyzed parameters included the areal BMD of the total hip, femoral neck, lumbar spine, and total body/whole skeleton. The BMD was measured using dual-energy X-ray absorptiometry (Lunar iDXA; GE Healthcare, Madison, WI, USA). Standard densitometric procedures and quality assurance were performed, and standard scanning conditions were used, according to official recommendations. The percent coefficient of variation of the dual-energy X-ray absorptiometry method was 2.8% for the total femur measurements. Individuals with femur T-scores of −1.0 and above were assigned to the normal T-score group, and those with T-scores below −1.0 to the low T-score group. An operational diagnosis of osteoporosis was made based on the International Society for Clinical Densitometry standard guidelines. However, the cutoff T-score of −1.0 was intentionally used for the stratification to prevent underestimation, and to identify participants at increased risk of low bone mass. | PMC10586687 |
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