Testing a Home-Based Model of Care Using Misoprostol for Prevention and Treatment of Postpartum Hemorrhage: Results From a Randomized Placebo-Controlled Trial Conducted in Badakhshan Province, Afghanistan

Uterotonics (medications that induce uterine contractions) are used to prevent and treat excessive bleeding due to failure of the uterus to contract adequately after childbirth, a potentially life-threatening complication. The World Health Organization (WHO) recommends using misoprostol when oxytocin, the uterotonic of choice, is not an option. Misoprostol has been proven to be effective in controlling PPH in large hospital-based studies; however, few studies have examined role of the uterotonic drug misoprostol when administered by lay providers to treat PPH outside of health facilities. This study was conducted in rural Afghanistan to determine the effectiveness and safety of treating women delivering at home with misoprostol. All women were dispensed misoprostol (600mcg) in advance and counselled to swallow the pills immediately after delivery to prevent PPH. Community health workers (CHW) were present during the birth to observe for signs of PPH and to place four pills -- misoprostol (800mcg) or placebo -- under the tongue of women identified as bleeding heavily. The study did not find differences in hemoglobin outcomes among women given misoprostol vs. placebo. But misoprostol was considered safe in the hands of CHWs, who were able to administer the medication correctly after identifying excessive bleeding. Women who received misoprostol to both prevent and treat PPH during the same birth did not report experiencing adverse effects or safety concerns. Read more on our  website .

A Cluster-Randomized, Non-Inferiority Trial Comparing Use of Misoprostol for Universal Prophylaxis vs. Secondary Prevention of Postpartum Hemorrhage Among Community Level Births in Egypt  

Previous community-based research shows that secondary prevention of PPH with misoprostol (treating only women experiencing above-average blood loss) produces similar clinical outcomes compared to routine administration of misoprostol for prevention of PPH. However, prior research on secondary prevention used blood collection drapes to measure exact quantities of postpartum blood loss and prompt administration of secondary prevention if blood loss exceeded a specified amount. Though a useful research tool, the blood collection drape is not widely available and is unlikely to be used on a large scale. This new study investigates a more operational model of triggering secondary prevention of PPH with misoprostol using an inexpensive, locally available absorbent underpad.

The study, conducted over a 15-month period in two predominantly rural districts in Egypt, included over 2600 women who delivered vaginally with a nurse-midwife at home or in a primary health unit. Nurse-midwives were randomly assigned to administer misoprostol using either universal prophylaxis or secondary prevention. Nurse-midwives in both groups were instructed to place the underpad underneath women after delivery and use it to collect and monitor blood loss. While misoprostol was administered to 100% of women in the primary prevention group and to only 11% of women in the secondary prevention group, there were no statistically significant differences in clinical outcomes as measured by change in pre- and post-delivery hemoglobin levels, PPH diagnosis, transfer to higher level care, or other interventions for PPH. These results add to the existing evidence suggesting that the secondary prevention approach is a promising alternative to universally medicating every woman who delivers in a community setting. Read more on our   website.

A Double-blind, Randomized Controlled Trial to Explore Oral Tranexamic Acid as Adjunct for the Treatment for Postpartum Hemorrhage

PPH can occur without warning and quickly lead to death. Timely treatment is urgently needed wherever women deliver. Tranexamic acid (TXA) is a blood clot stabilizer used for reduction of blood loss in trauma. Intravenous (IV) administration within 3 h of delivery has shown promise in reducing death from bleeding after childbirth and is recommended in clinical guidelines (WHO 2017). However, TXA is out of reach for most women with primary PPH in settings where IV administration is not feasible. TXA is widely available in tablet form at low cost and is stable at room temperature, so, if proven effective, its use for PPH in lower level health facilities and home births might be possible. This trial explored the potential of oral TXA as an adjunct to sublingual misoprostol to treat PPH following vaginal delivery. Two hundred and fifty-eight women with PPH were randomly assigned to receive sublingual misoprostol and either oral TXA or placebo. Providers measured blood loss for 2 h after administration of the medicines and recorded suspected cause of PPH, blood loss, additional interventions, and side effects. In this small sample, the addition of oral TXA did not confer any substantial advantage in treating primary PPH compared to misoprostol alone. Read more on our   website.

High Fever After Sublingual Administration of Misoprostol for Treatment of Postpartum Hemorrhage: A Hospital-based, Prospective Observational Study in Argentina  

We completed research in two hospitals in Corrientes, Argentina to document the rate of high fever (≥40⁰C / 104⁰F) following PPH treatment with misoprostol after vaginal birth. Shivering and fever were experienced by three-quarters (37/49) of women diagnosed and treated for PPH with misoprostol. Systematic temperature measurement after misoprostol administration confirmed a rate of high fever of 12.2% [95% confidence interval 4.6-24.8%]. Fever, irrespective of its severity, usually occurred between 60-90 minutes after receipt of the medicine and then gradually subsided. Overall, misoprostol’s thermoregulatory effects were confirmed to be self-limiting, non-life threatening, and generally acceptable to women. Blood samples for these women will be analyzed to determine if there is any genetic predisposition to experiencing this effect (results forthcoming). A clearer understanding of fever after misoprostol and the potential role of genetic factors will help providers know what to expect and to avoid unnecessary interventions.  Read more on our   website.

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