Intravenous versus intramuscular oxytocin injection for preventing uterine atonic primary postpartum haemorrhage in third stage of labour: A double-blind randomised controlled trial.

Objectives: To compare the efficacy and safety of intravenous and intramuscular oxytocin in preventing atonic primary postpartum haemorrhage in the third stage of labour. Methods: A double-blind randomised clinical study on consenting women without risk factors for primary postpartum haemorrhage in labour at term. Two hundred and thirty-two women were randomly allotted into intravenous (n = 115) and intramuscular (n = 117) oxytocin groups in the active management of the third stage of labour. All participants received 10 IU of oxytocin, either IV or IM, and 1 ml of water for injection as a placebo via a route alternate to that of administration of oxytocin within 1 min of the baby's delivery. The primary outcome measures were mean postpartum blood loss and haematocrit change. Trial Registration No.: PACTR201902721929705. Results: The baseline socio-demographic and clinical characteristics were similar between the two groups (p > 0.05). There was no statistically significant difference between the two groups with regards to the mean postpartum blood loss (254.17 ± 34.85 ml versus 249.4 ± 39.88 ml; p = 0.210), haematocrit change (2.4 (0.8%) versus 2.1 (0.6%); p = 0.412) or adverse effects (p > 0.05). However, the use of additional uterotonics was significantly higher in the intravenous group (25 (21.73%) versus 17 (14.53%); p = 0.032). Conclusion: Although oxytocin in both study groups showed similar efficacy in terms of preventing atonic primary postpartum haemorrhage, participants who received intravenous oxytocin were more likely to require additional uterotonics to reduce their likelihood of having an atonic primary postpartum haemorrhage. However, both routes have similar side effect profiles.

Association between serum vitamin D status and uterine leiomyomas: a case-control study.

OBJECTIVE: Uterine leiomyoma is a common gynecological condition that negatively affects women's quality of life. Vitamin D plays an important role in tumor development and progression. However, clinical studies comparing serum vitamin D levels between women with and without uterine leiomyomas are limited and inconclusive. This study aimed to compare serum vitamin D levels in women with and without uterine leiomyomas. METHODS: This hospital-based case-control study included 150 women who visited a gynecological clinic. The cases included 75 women with uterine leiomyoma, whereas the controls included 75 age-and parity-matched participants without uterine leiomyoma. Serum vitamin D levels were measured in each participant and volumes of the uterine leiomyomas were determined using the water displacement method following myomectomy. The statistical significance was inferred at P<0.05. RESULTS: The mean serum vitamin D level was 15.26±4.96 ng/mL and 22.45±6.93 ng/mL for the case and control groups, respectively. The difference was statistically significant (t-value -7.302 and P<0.001). Within the fibroid group, nine (12.0%), 49 (65.33%), and 17 (22.67%) participants had vitamin D deficiency, insufficiency, and sufficiency, respectively; and in the control group, two (2.67%), 24 (45.33%), and 39 (52.0%) participants had vitamin D deficiency, insufficiency, and sufficiency, respectively. There was significant negative correlation between the fibroid volume and the serum vitamin D level (r=-0.591, P<0.001). CONCLUSION: Women with uterine leiomyoma had lower vitamin D levels than women in the control group. Lower vitamin D levels were associated with larger fibroid masses. Therefore, vitamin D supplementation may reduce fibroid growth and development.

Exploring physicians' experiences under the national health insurance scheme in Southeastern Nigeria.

BACKGROUND: A number of low-and middle-income countries have implemented National Health Insurance Schemes (NHIS) as part of efforts to increase access to quality healthcare and financial protection from regressive out-of-pocket payments. This study explored physicians' experiences under the Nigerian (NHIS) to identify factors that may influence efficient health care delivery. METHODS: A convenient sample of 85 physicians residing in South-East Nigeria who had active contracts with the NHIS were surveyed via self-administered questionnaire for this study. Descriptive statistics were used to summarize the data while Kruskal-Wallis tests were used to determine if there were statistically significant associations between physician professional characteristics and their responses to key statements that assessed their experiences and behavior. Also, thematic analysis was used to assess additional qualitative data provided by study participants. RESULTS: Provider experiences were affected by the perceived inadequacy of reimbursement rates, delays in payment and services not covered by the NHIS. Participants' responses to statements on inadequacy of reimbursement was significantly associated with location using Kruskal-Wallis test (χ2 (1) = 7.24, p = 0.027) while billing patients for services not covered under the NHIS was significantly associated with length of years of practice (χ2 (1) = 15.5, p = 0.001) and place of employment (χ2 (1) = 5.82, p = 0.054). CONCLUSION: Physician experiences and challenges they face under the NHIS program in Nigeria have unintended effects on the delivery of health care services. It is imperative that these issues are addressed to improve health service delivery.

Primary Infertility Secondary to Posterior Urethral Valve.

A 34-year-old civil servant presented to our facility, following a referral from a gynecologist who was also seeing the wife. The man presented with a history of anejaculation and the inability to impregnate his wife after 23 months of marriage. History, physical examination, and ancillary investigation led to a diagnosis of primary infertility secondary to posterior urethral valve which was subsequently ablated. Three weeks after ablation, he started ejaculating, and 2 months later, the wife became pregnant.

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.

Accuracy of a combined insulin-like growth factor-binding protein-1/interleukin-6 test (Premaquick) in predicting delivery in women with threatened preterm labor.

PURPOSE: To determine values of combinations of interleukin-6 (IL-6)/cervical native insulin-like growth factor-binding protein-1 (IGFBP-1)/total IGFBP-1 (Premaquick©) in predicting spontaneous deliveries and spontaneous exclusive preterm deliveries in women with threatened preterm labor. METHODS: Women with singleton pregnancies between gestation age (GA) of 24 weeks and 36 weeks and 6 days with preterm labor were recruited during a prospective multicenter study. Premaquick© was positive when at least two of three biomarkers were positive. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were estimated for both prediction of spontaneous deliveries and spontaneous exclusive preterm deliveries. RESULTS: Ninety-seven (99.0%) out of 98 women enrolled were analyzed. Based on delivery status 7/14 days post-enrollment of general study population, Premaquick© had a sensitivity of 87.1/85.7%, a specificity of 92.4/96.8%, a PPV of 84.4/93.8% and a NPV of 93.9/92.3% for prediction of spontaneous delivery. Predictive accuracy of Premaquick© test in relation to days of enrollment were: 90.7% (≤7 days) and 92.8% (≤14 days). For women enrolled at GA <35 weeks, Premaquick© had a sensitivity of 100.0/87.5%, a specificity of 94.1/96.9%, a PPV of 70.5/87.5%, a NPV of 100.0/96.9% and an accuracy of 95.0/95.0% for prediction of preterm delivery within 7/14 days of enrollment, respectively. PPV was most significantly different in both groups when outcomes were compared between 2 days and 14 days post-enrollment (P<0.001). CONCLUSION: This novel triple biomarker model of native and total IGFBP-1 and IL-6 appears to be an accurate test in predicting spontaneous deliveries and spontaneous exclusive preterm deliveries in threatened preterm labor in singleton pregnancies.

Comparison of the duo of insulin-like growth factor binding protein-1/alpha fetoprotein (Amnioquick duo+®) and traditional clinical assessment for diagnosing premature rupture of fetal membranes.

PURPOSE: To determine the diagnostic accuracy of insulin-like growth factor binding protein-1/alpha fetoprotein (Amnioquick duo+®) compared with traditional clinical assessment (TCA) of nitrazine, ferning and pooling for the diagnosis of prelabor rupture of membranes (PROM). METHODS: A double-blinded, multicenter clinical study was conducted between February 2015 and August 2015 among pregnant women presenting with symptoms or features suggestive of PROM between 24 and 42 weeks gestation. Confirmation of PROM was done after delivery based on the presence of any two of these criteria: delivery within 48 h to 7 days, evidence of chorioamnionitis, membranes explicitly ruptured at delivery and adverse perinatal outcomes strongly correlated with prolonged PROM. Sensitivity, specificity and accuracy were outcome measures assessed. RESULTS: Two hundred and thirty-six women were recruited. Three women were excluded from the final analysis due to lack of follow-up data and failure to meet inclusion criteria. Two hundred and thirty-three women had complete data for analysis. The specificity and sensitivity values for TCA were 76.2% and 85.2%, which were lower than those of Amnioquick duo+, which were 97.6% and 97.9%, respectively. The accuracy of Amnioquick duo+ was statistically higher (97.9% vs. 83.7%; RR=1.17; 95%CI=1.10-1.24; P<0.001). In equivocal cases (pooling=negative), the accuracy of Amnioquick duo+ vs. TCA was 98.4% vs. 69.4% (RR=1.42; 95%CI=1.20-1.68; P<0.001) at ≥34 weeks gestation and 100.0% vs. 71.4% (RR=1.40; 95%CI=1.07-1.83; P=0.021) at <34 weeks gestation. CONCLUSION: The performance matrix of Amnioquick duo+® was superior to that of TCA for diagnosing PROM even in equivocal cases.

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.

Accuracy and cost-analysis of placental alpha-microglobulin-1 test in the diagnosis of premature rupture of fetal membranes in resource-limited community settings.

AIM: To determine accuracy and costs of placental α-microglobulin-1 (PAMG-1) test compared to standard clinical assessment (SCA) for diagnosing rupture of membranes (ROM). METHODS: A multicenter double-blind study of consecutive women with symptoms and signs of ROM in Nnamdi Azikiwe University Teaching Hospital, Nnewi and University of Nigeria Teaching Hospital, Enugu, both in south-east Nigeria using SCA for ROM and the PAMG-1 test was done. ROM was diagnosed if two out of three methods from SCA (pooling, positive nitrazine test or ferning) were present and confirmed post-delivery based on presence of any two of these clinical criteria: delivery in 48 h to 7 days, evidence of chorioamnionitis, membranes overtly ruptured at delivery and adverse perinatal outcomes strongly correlated with prolonged PROM. A cost-analysis was also done. The outcome measures included sensitivity, specificity, accuracy and costs for the two tests. RESULTS: Accuracy, sensitivity and specificity for the PAMG-1 test were 97.2%, 97.4% and 96.7%, higher than for SCA which were 83.7%, 87.9% and 70.5%, respectively (P < 0.001). Accuracy of SCA was higher at less than 34 weeks than 34 weeks or more (88.3% vs 81.4%) while the PAMG-1 test performed equally at both gestational age categories (96.1% vs 97.7%). In women without pooling, accuracy of the PAMG-1 test was 96.7%, while it was 40.0% with SCA. Analysis showed that the overall cost of SCA was 45% higher than the PAMG-1 test. CONCLUSION: This study confirms that the PAMG-1 test has a consistently high diagnostic accuracy at all gestational ages and with equivocal cases of ROM. The PAMG-1 test appears less costly than SCA.