Shobhana S. Patted

Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial

BACKGROUND Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting. METHODS In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as > or =500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www. clinicaltrials.gov) as number NCT00097123. FINDINGS Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p<0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p<0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p<0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control. INTERPRETATION Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drugs low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.

Drape estimation vs. visual assessment for estimating postpartum hemorrhage

Objective: To compare (1) visual estimation of postpartum blood loss with estimation using a specifically designed blood collection drape and (2) the drape estimate with a measurement of blood loss by photospectrometry. Methods: A randomized controlled study was performed with 123 women delivered at the District Hospital, Belgaum, India. The women were randomized to visual or drape estimation of blood loss. A subsample of 10 drape estimates was compared with photospectrometry results. Results: The visual estimate of blood loss was 33% less than the drape estimate. The interclass correlation of the drape estimate to photospectrometry measurement was 0.92. Conclusion: Drape estimation of blood loss is more accurate than visual estimation and may have particular utility in the developing world. Prompt detection of postpartum hemorrhage may reduce maternal morbidity and mortality in low‐resource settings.

Side effects of oral misoprostol for the prevention of postpartum hemorrhage: Results of a community-based randomised controlled trial in rural India

Objective. To investigate the side effects of 600 μg oral misoprostol given for the mother and the newborn to prevent postpartum hemorrhage (PPH). Methods. One thousand six hundred twenty women delivering at home or subcentres in rural India were randomised to receive misoprostol or placebo in the third stage of labour. Women were evaluated for shivering, fever, nausea, vomiting and diarrhea at 2 and 24 h postpartum. Newborns were evaluated within 24 h for diarrhea, vomiting and fever. Symptoms were graded as absent, mild-to-moderate or severe. Results. Women who received misoprostol had a significantly greater incidence of shivering (52%vs. 17%, p < 0.001) and fever (4.2%vs. 1.1%, p < 0.001) at 2 h postpartum compared with women who received placebo. At 24 h, women in the misoprostol group experienced significantly more shivering (4.6%vs. 1.4%, p < 0.001) and fever (1.4%vs. 0.4%, p < 0.03). There were no differences in nausea, vomiting or diarrhea between the two groups. There were no differences in the incidence of vomiting, diarrhea or fever for newborns. Conclusions. Misoprostol is associated with a significant increase in postpartum maternal shivering and fever with no side effects for the newborn. Given its proven efficacy for the prevention of PPH, the benefits of misoprostol are greater than the associated risks.

Factors associated with acute postpartum hemorrhage in low-risk women delivering in rural India.

Postpartum hemorrhage (PPH), a major cause of maternal mortality and morbidity in low‐income countries, can occur unpredictably. This study examined the sociodemographic, clinical, and perinatal characteristics of low‐risk women who experienced PPH.

Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol

Objective. The main objective of this study was to identify factors associated with variation in the rate of acute postpartum hemorrhage (PPH), defined as blood loss ≥ 500 mL within 2 hours of delivery, observed in a randomized clinical trial of misoprostol for the prevention of PPH, conducted in rural India. Although the women in the misoprostol group had a significantly lower probability of having a PPH, we also noted a reduction in the rate of PPH in the placebo group over the course of the study. We hypothesized that this was due to the changing skills of the auxiliary nurse midwives (ANMs) over the course of the study. Methods. We conducted a post-hoc analysis examining variation in PPH rates over the duration of the trial among the women randomized to the placebo arm (n = 808). Descriptive, correlation analysis and generalized estimating equations (GEE) were used to predict PPH rates. With no direct measure of ANM skills, we used proxy measures, including: (1) the ANMs point of entry into the study (original ANMs at the initiation of the trial were less skilled than replacement ANMs); (2) the study duration, representing exposure of the ANM to ongoing training and monitoring; and (3) duration of the second stage of labor as a measure of improved delivery practices. Results. As the study duration increased, the duration of the second stage of labor decreased (−0.12, p = 0.001) and as the duration of the second stage of labor decreased, the rate of PPH decreased (0.0282; 95% CI 0.0201–0.0363). For each 10-minute increase in the duration of second stage labor increased PPH odds by 7.1% and each 30-day duration of the trial decreased PPH odds by 3.4%. Additionally, a patient delivered by an original ANM was 3.14 times more likely to have a PPH compared to a patient delivered by a replacement ANM. Conclusions. Declining PPH rates were associated with improved skills and delivery practices that decreased duration of the second stage of labor. These improvements appeared to be consistent with the introduction of the more skilled replacement ANMs as well as ongoing training and monitoring for all ANMs over the duration of the trial.

Determinants of Intimate Partner Violence Among HIV-Positive and HIV-Negative Women in India

To reduce the many adverse health outcomes associated with intimate partner violence (IPV), high-risk groups need to be specifically targeted in the fight against domestic violence in India. This study aims to examine the prevalence and correlates of IPV in HIV-positive and HIV-negative women from India. A convenience sample of HIV-positive and HIV-negative women responded to questionnaires to assess their experience and perception of violence. Multivariate logistic regression analysis was used to model the association between IPV and age, education, employment status, contraception use, age at first marriage, and HIV status. Although adjusting for age, education, employment status, contraception use, age at first marriage, and HIV status, women who are employed were 3.5 times more likely to suffer IPV (confidence interval [CI] = [1.5, 8.5]), women aged 18 or above at first marriage are 0.3 times less likely to face IPV (CI = [0.1, 0.6]), and women who use contraception are 7 times more likely to suffer IPV (CI = [1.4, 30.2]). Also, HIV-positive women are 3 times more likely to face sexual violence compared with HIV-negative women (CI = [1.1, 7.6]).

Training rural health care providers for prevention of PPH

Maternal mortality in India is an unresolved issue with more than 130,000 deaths every year. Home births remain a strong preference and often the only option for many women in rural locations [1]. Post partum hemorrhage (PPH) accounts for approximately 25---30% of maternal deaths in India [2]. Intervention with an effective drug at the time of delivery by a skilled attendant would be a crucial factor in averting death due to PPH. However, such individuals are not routinely present and many women deliver only in the company of concerned family members who, although they have assisted many times, are not skilled or trained birth attendants. This study tested whether use of 600 mcg of oral misoprostol, administered during the third stage of labor by auxiliary nurse midwives (skilled birth attendants) reduced the incidence of postpartum hemorrhage. Nineteen auxiliary nurse midwives (ANMs) from four primary health centers (PHC), Karnataka, India administered the intervention to 1620 women. The ANMs were responsible for screening and recruiting the study participants, obtaining informed consent, randomization, delivery of the intervention, measuring the blood loss and following the participants during the 6 weeks postpartum. The training of the ANMS included screening for