Efficacy and safety of Mojeaga remedy in combination with conventional oral iron therapy for correcting anemia in obstetric population: A phase II randomized pilot clinical trial.

BACKGROUND: To our knowledge, there is no prior randomized trial on the efficacy of Mojeaga remedy (a special blend of Alchornea cordifolia, Pennisetum glaucum and Sorghum bicolor extracts) when co-administered with standard-of-care for correction of anemia in obstetrics practice. This study determined the efficacy, safety and tolerability of Mojeaga as adjunct to conventional oral iron therapy for correction of anemia in obstetric population. METHODS: A pilot open-label randomized clinical trial. Participants with confirmed diagnosis of anemia in three tertiary hospitals in Nigeria were studied. Eligible participants were randomized 1:1 to either Mojeaga syrups 50 mls (200mg/50mls) administered three times daily in conjunction with conventional iron therapy (Mojeaga group) for 2 weeks or conventional iron therapy alone without Mojeaga (standard-of-care group) for 2 weeks. Repeat hematocrit level were done 2 weeks post-initial therapy. Primary outcome measures were changes in hematocrit level and median hematocrit level at two weeks post therapy. Maternal adverse events and neonatal outcomes (birth anomalies, low birthweight, preterm rupture of membranes and preterm labor) were considered the safety outcome measures. Analysis was by intention-to-treat. RESULTS: Ninety five participants were enrolled and randomly assigned to the Mojeaga group (n = 48) or standard-of-care group (n = 47). The baseline socio-demographic and clinical characteristics of the study participants were similar. At two weeks follow-up the median rise in hematocrit values from baseline (10.00±7.00% vs 6.00±4.00%;p<0.001) and median hematocrit values (31.00±2.00% vs 27.00±3.00%;p<0.001) were significantly higher in the Mojeaga group. There were no treatment-related serious adverse events, congenital anomalies or deaths in the Mojeaga group and incidence of other neonatal outcomes were similar (p>0.05). CONCLUSION: Mojeaga represents a new adjuvants for standard-of-care option for patients with anemia. Mojeaga remedy is safe for treating anemia during pregnancy and puerperium without increasing the incidence of congenital anomalies, or adverse neonatal outcomes. CLINICAL TRIAL REGISTRATION: www.pactr.samrc.ac.za: PACTR201901852059636 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5822).

Predictors of puerperal menstruation.

BACKGROUND: Puerperal period is an important and thought-provoking period for puerperal mothers. Surprisingly, reports have indicated that there is increasing number of women resuming menstruation within six weeks of childbirth (puerperal menstruation). To the best of knowledge, there is no prior study on predictors of puerperal menstruation. OBJECTIVE: To determine frequency and predictors of puerperal menstruation. METHODS: This was a single tertiary health institution cross-sectional study at ESUT Teaching Hospital, Parklane, Enugu, Nigeria that included data from May 2015 to December 2018. Women were interviewed at the end of the first six weeks of their childbirth. Women with HIV positive or had uterine rupture or peripartum hysterectomy were excluded. Bivariate analysis was performed by the chi-squared test and conditional logistic regression analysis was used to determine variables associated with puerperal menstruation. Statistical significance was accepted when P- value is <0.05. RESULTS: A total of 371 women met the inclusion criteria. The return of menses within 6 weeks was present in 118(31.8%) women versus 253 (68.2%) women without puerperal menstruation, given a ratio of 1:3. Of the 371 women, 249 (67.1%) were on exclusive breastfeeding. The significant associated risk factors were age (p = 0.009), parity (p<0.001), early use of family planning (p = 0.001), socio-economic status (p<0.001) and manual removal of placenta (p = 0.007). At conditional logistic regression analysis, early use of family planning (p = 0.001), exclusive breastfeeding (p = 0.027) and manual removal of placenta (p = 0.012) were independently associated with puerperal menstruation. Induction/augmentation of labor, postpartum misoprostol use and mode of delivery were not statistically significant (p>0.05, for all). CONCLUSION: One in 3 women resumes menstruation within 6 weeks of childbirth. The major predictor was early initiation of family planning, and exclusive breastfeeding with manual removal of placenta a major protective factor. These interesting issues require further investigation to better understand the mechanism of puerperal menstruation.