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NCT Number: NCT01462422

Misoprostol for Secondary Prevention of Postpartum Hemorrhage at the Community Level in India

This study compares two community-level strategies: selective administration of 800 mcg sublingual misoprostol to women at 350 mL blood loss for secondary prevention of postpartum hemorrhage (PPH) with universal use of 600 mcg oral misoprostol at the time of delivery for primary prevention of PPH. The study hypothesizes that at community-level births, secondary prevention for women is non-inferior (based on clinical parameters) to universal prophylaxis provided to women for primary prevention of PPH. This cluster-design non-inferiority trial has the potential to inform service delivery programs on clinical outcomes, program feasibility, cost and acceptability of two different community models of PPH care using misoprostol.

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Deliveries at health sub-centers and homes

Vijayapura, Karnataka, 586103, India

About this study

Rationale for Research: There is an absence of concrete data on the programmatic and cost-effectiveness of different service delivery models for prevention and treatment of postpartum hemorrhage with misoprostol, prompting a discussion of whether resources are best spent on misoprostol for primary prevention at lower levels (with treatment carried out at higher levels via referral) or whether immediate proactive treatment strategies should be considered. As the training and policy implications of universal prevention versus selective treatment approaches vary, simple and effective service delivery models are urgently needed to help governments and organizations decide how to best focus their limited resources. This study proposes to study the efficacy of a hybrid strategy (i.e., secondary prevention) that combines elements of prevention and treatment. Results of this study could provide a new model of care that will medicate fewer women, save costs and address the clinical conundrum of guessing at the safety of administering a prevention dose of misoprostol followed quickly by a larger treatment dose.

Study design: This randomized cluster trial will recruit women with deliveries attended by auxiliary nurse midwives (ANMs) that occur at homes or at health sub-centers. ANMs will be randomized to administer the intervention as described in the primary or secondary prevention arm.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • delivering at home or sub-center with an auxilliary nurse midwife (ANM)
  • able and willing to provide informed consent
  • meeting Ministry of Health Guidelines for home or sub-center delivery

Exclusion criteria

  • high-risk pregnancy

Treatment and study plan

Misoprostol

Drug

Selective administration of 800 mcg sublingual misoprostol to women with at least 350 mL blood loss within 1 hour following delivery

Primary outcomes

  1. Proportion of women with post-delivery hemoglobin ≤ 7.8 gm/dL

    Time frame: 72 hours (plus or minus 8 hours) after delivery

    A 20% rate of post delivery Hb ≤7.8 gm/dL in the study arm with women receiving selective administration of 800 mcg sublingual misoprostol is non-inferior to a 13% rate of post delivery Hb ≤ 7.8 gm/dL in the study arm with women receiving universal 600 mcg oral misoprostol prophylaxis.

Secondary outcomes

  1. Rate of transfer to referral facilities for PPH

    Time frame: within 72 hours (plus or minus 8 hours) after delivery

    Proportion of women who are transferred from the location of delivery to higher level of care because the birth attendent diagnosed or suspected PPH.

  2. Rate of PPH

    Time frame: within 1 hour after delivery

    Proportion of women with 500 mL-999 mL blood loss following delivery, as measured by a calibrated blood collection drape.

  3. Rate of severe PPH

    Time frame: within 1 hour after delivery

    Proportion of women with > 1000 mL blood loss following delivery, as measured by a calibrated blood collection drape.

  4. Rate of adverse events

    Time frame: Within 72 hours (plus or minus 8 hours) after delivery

    Adverse events include prolonged hospitalization, permanent or serious disability, additional threat to life, or death.

  5. Mean blood loss

    Time frame: 1 hour after delivery

    Blood loss will be measured using a blood collection drape, calibrated at 50 mL intervals.

  6. Rate of additional interventions needed to control bleeding

    Time frame: within 72 hours (plus or minus 8 hours) after delivery

    Addtional interventions include administration of other uterotonics (e.g., oxytocin), IV fluids, comprehensive emergency obstetric care, blood transfusion and surgery

  7. Cost-effectiveness

    Time frame: 72 hours (plus or minus 8 hours) after delivery

    The cost-effectiveness of the two interventions will be compared. The cost-effectiveness measure will utilize information collected on cost of the study drug, materials used to control bleeding, and the cost of transfer and subsequent care received by women who are in in need of higher level care.

  8. Proportion of women reporting known side effects of misoprostol

    Time frame: 1 hour after delivery

    Recognized side-effects of misoprostol include: Shivering, fever, headache, nausea, vomiting and diarrhea. Rare side effects include: abdominal pain from uterine cramping, seizures and palpitations (only with overdosing). All women in both study arms, including those in the secondary prevention arm who do not receive the study drug, will be asked if they experienced any of these symptoms.

  9. Acceptability of intervention to women

    Time frame: 72 hours (plus or minus 8 hours) after delivery

    A brief exit interview will be conducted with participants to assess their acceptability of the intervention, including tolerability of any side effects experienced.

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Jawaharlal Nehru Medical College
  • Sri B. M. Patil Medical College, Bijapur, Karnataka, India
  • University of California, San Francisco
  • University of Illinois at Chicago

Registry information

Official study title

Two Community Strategies Comparing Use of Misoprostol for Secondary Prevention to Primary Prevention for Postpartum Hemorrhage: A Randomized Cluster Non-Inferiority Study in Bijapur District, Karnataka, India

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 31, 2011
Registry last updated
Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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