Clinical trial NCT01462422: Misoprostol for Secondary Prevention of Postpartum Hemorrhage at the Community Level in India
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Postpartum hemorrhage
Prevention
Misoprostol
Developing countries
Nurse midwife
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Sri B. M. Patil Medical College, Bijapur, Karnataka, India
name: Jawaharlal Nehru Medical College
name: University of Illinois at Chicago
name: University of California, San Francisco
First posted: 2011-10-31
Enrollment: 3032
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. high-risk pregnancy

Primary outcomes:
measure: Proportion of women with post-delivery hemoglobin ≤ 7.8 gm/dL
timeFrame: 72 hours (plus or minus 8 hours) after delivery
Secondary outcomes:
measure: Rate of transfer to referral facilities for PPH
timeFrame: within 72 hours (plus or minus 8 hours) after delivery
measure: Rate of PPH
timeFrame: within 1 hour after delivery
measure: Rate of severe PPH
timeFrame: within 1 hour after delivery
measure: Rate of adverse events
timeFrame: Within 72 hours (plus or minus 8 hours) after delivery
measure: Mean blood loss
timeFrame: 1 hour after delivery
measure: Rate of additional interventions needed to control bleeding
timeFrame: within 72 hours (plus or minus 8 hours) after delivery
measure: Cost-effectiveness
timeFrame: 72 hours (plus or minus 8 hours) after delivery
measure: Proportion of women reporting known side effects of misoprostol
timeFrame: 1 hour after delivery
measure: Acceptability of intervention to women
timeFrame: 72 hours (plus or minus 8 hours) after delivery
Other outcomes:
Locations:
city: Bijapur
country: India
facility: Deliveries at health sub-centers and homes
state: Karnataka
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Sheila Raghavan, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Stacie Gellar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Suellen Miller, PhD, CNM
role: PRINCIPAL_INVESTIGATOR
affiliation: Jawaharlal Nehru Medical College
name: Shivaprasad S Goudar, MD, MHPE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.