Prophylactic tranexamic acid for reducing intraoperative blood loss during cesarean section in women at high risk of postpartum hemorrhage: A double-blind placebo randomized controlled trial.

BACKGROUND: Postpartum hemorrhage remains a leading cause of maternal mortality especially in developing countries. The majority of previous trials on the effectiveness of tranexamic acid in reducing blood loss were performed in low-risk women for postpartum hemorrhage. A recent Cochrane Systematic Review recommended that further research was needed to determine the effects of prophylactic tranexamic acid for preventing intraoperative blood loss in women at high risk of postpartum hemorrhage. OBJECTIVE: This study aimed to evaluate the effectiveness and safety of tranexamic acid in reducing intraoperative blood loss when given prior to cesarean delivery in women at high risk of postpartum hemorrhage. STUDY DESIGN: The study is a double-blind randomized controlled trial. METHODS: The study consisted of 200 term pregnant women and high-risk preterm pregnancies scheduled for lower-segment cesarean delivery at Enugu State University of Science and Technology, Teaching Hospital, Parklane, Enugu, Nigeria. The participants were randomized into two arms (intravenous 1 g of tranexamic acid or placebo) in a ratio of 1:1. The participants received either 1 g of tranexamic acid or placebo (20 mL of normal saline) intravenously at least 10 min prior to commencement of the surgery. The primary outcome measures were the mean intraoperative blood loss and hematocrit change 48 h postoperatively. RESULTS: The baseline sociodemographic characteristics were similar in both groups. The tranexamic acid group when compared to the placebo group showed significantly lower mean blood loss (442.94 ± 200.97 versus 801.28 ± 258.68 mL; p = 0.001), higher mean postoperative hemoglobin (10.39 + 0.96 versus 9.67 ± 0.86 g/dL; p = 0.001), lower incidence of postpartum hemorrhage (1.0% versus 19.0%; p = 0.001), and lower need for use of additional uterotonic agents after routine management of the third stage of labor (39.0% versus 68.0%; p = 0.001), respectively. However, there was no significant difference in the mean preoperative hemoglobin (11.24 ± 0.88 versus 11.15 ± 0.90 g/dL; p = 0.457), need for other surgical intervention for postpartum hemorrhage (p > 0.05), and reported side effect, respectively, between the two groups. CONCLUSION: Prophylactic administration of tranexamic acid significantly decreases postpartum blood loss, improves postpartum hemoglobin, decreases the need for additional uterotonics, and prevents postpartum hemorrhage following cesarean section in pregnant women at high risk of postpartum hemorrhage. Its routine use during cesarean section in high-risk women may be encouraged.The trial was registered in the Pan-African Clinical Trial Registry with approval number PACTR202107872851363.

Active versus expectant management for premature rupture of membranes at term: A randomized, controlled study.

OBJECTIVE: To compare the effects on feto-maternal outcomes of expectant versus active management for premature rupture of membranes (PROM) at term. METHODS: This was a prospective randomized (1:1) controlled study involving 86 pregnant-women who received either expectant management (n = 43) or active management with misoprostol (n = 43) for PROM at term. Primary outcome was route of delivery. Secondary outcomes were: PROM to presentation interval; latency period; PROM to delivery interval; recruitment to delivery interval; labour and delivery complications. RESULTS: Baseline-characteristics were similar between groups. There was no significant difference between active and expectant groups in mean PROM to presentation/admission, or PROM to delivery. However, mean latency period (11.1 ± 7.3 hours vs 8.8 ± 5.5 hours) and mean recruitment to delivery intervals after PROM (14.7 ± 5.2 hours vs 11.8 ± 5.0 hours) were significantly shorter for the active group compared with the expectant group. Although the rate of caesarean section was less in expectant management group (21%) compared with the active management group (30%), the difference was not statistically significant. There were no significant differences between groups in delivery or perinatal complications. CONCLUSION: Active and expectant management for PROM at term gave comparable outcomes in terms of methods of delivery and complications. However, active management significantly shortened the latency period and induction to delivery intervals compared with expectant management.Trial-Registration: Pan-African-trial-registry-(PACTR)-approval-number PACTR202206797734088.

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.

Accuracy and response time of dual biomarker model of insulin-like growth factor binding protein-1/ alpha fetoprotein (Amnioquick duo+) in comparison to placental alpha-microglobulin-1 test in diagnosis of premature rupture of membranes.

AIM: The aim of this study was to determine accuracy and response time of duo of insulin-like growth factor binding protein-1 (IGFBP-1)/alpha-fetoprotein (Amnioquick duo+) versus placental alpha-microglobulin-1 (PAMG-1) in diagnosing premature rupture of membranes (PROM). METHODS: A multicenter prospective study was conducted among women with features suggestive of PROM between 24 and 42 gestational weeks (GW). PROM was confirmed post-delivery based on presence of any two of these criteria: delivery within 48 h to 7 days, chorioamnionitis, membranes overtly ruptured at delivery, and adverse perinatal outcomes strongly correlated with prolonged PROM. Response time analysis was also done. Outcome measures included specificity, sensitivity, positive predictive value, negative predictive value, accuracy, and response time for both tests. RESULTS: Sensitivity, specificity, and accuracy for Amnioquick duo+ were 97.9%, 97.6%, and 97.9%, which were higher than the levels for PAMG-1, of 95.3%, 90.0%, and 95.7%, respectively (not significant). Accuracy of Amnioquick duo+ versus PAMG-1 in equivocal (pooling = negative) cases was (98.4% vs 96.8%) at ≥34 GW but each was 100.0% at <34 GW (not significant). Overall diagnostic concordance rate of Amnioquick duo+ and PAMG-1 was 97.0% and both have equal positive predictive value (99.5%). Response time analysis showed that the overall response time of PAMG-1 was 4.5% higher than that of Amnioquick duo+. CONCLUSION: This is the largest study to date to reveal that Amnioquick duo+ and PAMG-1 have a comparatively high diagnostic accuracy in identifying women with PROM, with a concordance rate of 97.0%. The diagnostic response time of Amnioquick duo+ appears shorter. In equivocal cases, accuracy of Amnioquick duo+ was equal to that of the PAMG-1.

Diagnostic performance of placental alpha-microglobulin-1 test in women with prolonged pre-labour rupture of membranes.

OBJECTIVES: To determine diagnostic performance of placental alpha-microglobulin-1 (PAMG-1) test compared to conventional clinical assessment (CCA) in women with prolonged pre-labour rupture of membranes (PROM). METHODS: A double-blind study of women with symptoms and signs of PROM in Nnamdi Azikiwe University Teaching Hospital, Nnewi and University of Nigeria Teaching Hospital, Enugu, in south-east Nigeria using CCA for PROM and PAMG-1 test was done. Women were included if their symptoms, signs or complaints suggestive of PROM was more than 24 h duration. PROM was diagnosed if two out of three methods from CCA (pooling, positive nitrazine test or ferning) were present. Confirmation of PROM was done after delivery using any two of these clinical criteria: delivery in 48 h to 7 days, evidence of chorioamnionitis, membranes obviously ruptured at delivery and adverse perinatal outcomes strongly correlated with prolonged PROM. RESULTS: Accuracy, specificity and sensitivity value for CCA were 72.5, 36.8 and 86.0% lower than for PAMG-1 test which were 95.7, 94.1 and 96.2%. In equivocal cases, PAMG-1 was significantly more accurate than CCA (92.3% versus 38.5%; p < 0.001). CONCLUSIONS: This study in women with prolonged PROM, confirms that PAMG-1 test has high diagnostic accuracy irrespective of the duration of PROM before clinical evaluation.

Maternal and perinatal outcomes of delivery after a previous Cesarean section in Enugu, Southeast Nigeria: a prospective observational study.

BACKGROUND: Obstetricians in developing countries appear generally reluctant to conduct vaginal delivery in women with a previous Cesarean because of lack of adequate facilities for optimal fetomaternal monitoring. OBJECTIVE: To describe delivery outcomes among women with one previous Cesarean section at a tertiary hospital in Southeast Nigeria. METHODS: This was a prospective observational study to determine maternal and perinatal outcomes of attempted vaginal birth after Cesarean sections (VBAC) following one previous Cesarean section. Analysis was done with SPSS statistical software version 17.0 for Windows using descriptive and inferential statistics at 95% level of confidence. RESULTS: Two thousand six hundred and ten women delivered in the center during the study period, of whom 395 had one previous Cesarean section. A total of 370 women with one previous Cesarean section had nonrecurrent indications, of whom 355 consenting pregnant women with one previous Cesarean section were studied. A majority of the women (320/355, 90.1%) preferred to have vaginal delivery despite the one previous Cesarean section. However, only approximately 54% (190/355) were found suitable for trial of VBAC, out of whom 50% (95/190 had successful VBAC. Ninety-five women (50.0%) had failed attempt at VBAC and were delivered by emergency Cesarean section while 35 women (9.8%) had emergency Cesarean section for other obstetric indications (apart from failed VBAC). There was no case of uterine rupture or neonatal and maternal deaths recorded in any group. Apgar scores of less than 7 in the first minute were significantly more frequent amongst women who had vaginal delivery when compared to those who had elective repeat Cesarean section (P=0.03). CONCLUSION: Most women who had one previous Cesarean delivery chose to undergo trial of VBAC, although only about half were considered suitable for VBAC. The maternal and fetal outcomes of trial of VBAC in selected women with one previous Cesarean delivery for non-recurrent indications were good. Obstetricians in this area should do more to allow VBAC in women with one previous Cesarean section for nonrecurrent indications.

Acceptability of artificial donor insemination among infertile couples in Enugu, southeastern Nigeria.

BACKGROUND: Male factor infertility presents one of the greatest challenges with respect to infertility treatment in Africa. Artificial insemination by donor semen (AID) is a cost-effective option for infertile couples, but its practice may be influenced by sociocultural considerations. The purpose of this study was to determine the awareness and acceptability of AID among infertile couples in Enugu, southeastern Nigeria, and identify the sociocultural factors associated with its practices. METHODS: Questionnaires were administered to a cross-section of 200 consecutive infertile couples accessing care at the infertility clinics of two tertiary health institutions in Enugu, Nigeria, between April 1, 2012 and January 31, 2013. RESULTS: Among the 384 respondents, the level of awareness and acceptability of AID were 46.6% (179/384) and 43% (77/179), respectively. The acceptability rate was significantly higher among female respondents, women with primary infertility, and those whose infertility had lasted for 5 years and beyond (P<0.05). The major reasons for nonacceptance of AID were religious conviction (34.7%, n=33), cultural concern (17.9%, n=17), fear of contracting an infection (17.9%, n=17), and fear of possibility of failure of the procedure (12.6%, n=12). CONCLUSION: Health education and public enlightenment are advocated to increase awareness and dispel the current misconceptions about AID in our environment.

Ethical aspects of obstetric care: expectations and experiences of patients in South East Nigeria.

BACKGROUND: Medical ethics is not given due priority in obstetric care in many developing countries, and the extent to which patients value compliance with ethical precepts is largely unexplored. OBJECTIVE: To describe the expectations and experiences of obstetric patients in South East Nigeria with respect to how medical ethics principles were adhered to during their care. METHODS: This was a cross-sectional, questionnaire-based study involving parturient women followed in three tertiary hospitals in South East Nigeria. RESULTS: A total of 1,112 women were studied. The mean age of respondents was 29.7 ± 4.1 years. Approximately 98% had at least secondary education. Ninety-six percent considered ethical aspects of care as important. On the average, over 75% of patients expected their doctors to comply with the different principles of medical ethics and specifically, more than 76% of respondents expected their doctors to comply with ethical principles related to information and consent during their antenatal and delivery care. There was a statistically significant difference between the proportions of women who expected compliance of doctors with ethical principles and those who did not (P < 0.001). Multivariate analysis showed that increasing levels of skilled occupation (odds ratio [OR] 9.35, P < 0.001), and residence in urban areas (OR 2.41, P < 0.001) increased the likelihood of patients expecting to be informed about their medical conditions and their opinions being sought. Although the self-reported experiences of patients concerning adherence to ethical principles by doctors were encouraging, experiences fell short of expectations, as the level of expectation of patients was significantly higher than the level of observed compliance for all the principles of medical ethics. CONCLUSION: The level of practice of medical ethics principles by doctors during obstetric care in South East Nigeria was encouraging but still fell short of the expectations of patients. It is recommended that curriculum-based training of doctors and medical students should be implemented, and hospital policy makers should do more to promote ethical aspects of care, by providing official written guidelines for adherence to medical ethical principles during obstetric care.

Retrospective cohort study of the effects of obesity in early pregnancy on maternal weight gain and obstetric outcomes in an obstetric population in Africa.

OBJECTIVE: The purpose of this study was to compare maternal weight gain in pregnancy and obstetric outcomes between women with obesity in early pregnancy and those with a normal body mass index (BMI) in early pregnancy. METHODS: This was a retrospective cohort study of women with obesity in early pregnancy and those with a normal BMI who were seen at three teaching hospitals in South-East Nigeria. Statistical analysis was performed using Statistical Package for the Social Sciences version 17.0 software, with descriptive and inferential statistics at the 95% level of confidence. RESULTS: The study sample consisted of 648 women (324 obese and 324 healthy-weight). The mean age of the obese women was 26.7 ± 5.1 years and that of the healthy-weight women was 26.6 ± 4.9 years. Although both excessive weight gain (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.23-0.54) and inadequate weight gain (OR 0.08, 95% CI 0.04-0.15) were less common in women with early pregnancy obesity than in healthy-weight women, a significantly higher proportion of obese women with excessive weight gain had adverse fetomaternal outcomes. Also, a significantly higher proportion of obese women had specific complications, such as premature rupture of membranes (OR 2.36, 95% CI 1.12-5.04), gestational hypertension/pre-eclampsia (OR 2.31, 95% CI 1.12-5.04), antepartum hemorrhage (OR 2.78, 95% CI 1.02-7.93), gestational diabetes (OR 4.24, 95% CI 1.62-11.74), cesarean delivery (OR 2.3, 95% CI 1.2-5.44), macrosomia (OR 4.08, 95% CI 1.06-8.41), severe birth asphyxia (OR 2.8, 95% CI 1.2-6.63), abnormal Apgar scores (OR 2.67, 95% CI 1.46-4.93), and newborn special care admissions (OR 1.18, 95% CI 1.0-3.29). CONCLUSION: Early pregnancy obesity was associated with a wide range of adverse fetomaternal outcomes, and could be a genuine risk factor for increased pregnancy-related morbidity and/or mortality in this population. Interventions to reduce prepregnancy obesity could therefore be useful in this low-resource African setting.