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

This study is currently recruiting participants.
Verified June 2013 by Gynuity Health Projects
Sponsor:
Collaborators:
Sri B. M. Patil Medical College, Bijapur, Karnataka, India
Jawaharlal Nehru Medical College
University of Illinois at Chicago
University of California, San Francisco
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01462422
First received: October 27, 2011
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
Drug: Misoprostol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Proportion of women with post-delivery hemoglobin ≤ 7.8 gm/dL [ Time Frame: 72 hours (plus or minus 8 hours) after delivery ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Rate of transfer to referral facilities for PPH [ Time Frame: within 72 hours (plus or minus 8 hours) after delivery ] [ Designated as safety issue: Yes ]
    Proportion of women who are transferred from the location of delivery to higher level of care because the birth attendent diagnosed or suspected PPH.

  • Rate of PPH [ Time Frame: within 1 hour after delivery ] [ Designated as safety issue: Yes ]
    Proportion of women with 500 mL-999 mL blood loss following delivery, as measured by a calibrated blood collection drape.

  • Rate of severe PPH [ Time Frame: within 1 hour after delivery ] [ Designated as safety issue: Yes ]
    Proportion of women with > 1000 mL blood loss following delivery, as measured by a calibrated blood collection drape.

  • Rate of adverse events [ Time Frame: Within 72 hours (plus or minus 8 hours) after delivery ] [ Designated as safety issue: Yes ]
    Adverse events include prolonged hospitalization, permanent or serious disability, additional threat to life, or death.

  • Mean blood loss [ Time Frame: 1 hour after delivery ] [ Designated as safety issue: Yes ]
    Blood loss will be measured using a blood collection drape, calibrated at 50 mL intervals.

  • Rate of additional interventions needed to control bleeding [ Time Frame: within 72 hours (plus or minus 8 hours) after delivery ] [ Designated as safety issue: Yes ]
    Addtional interventions include administration of other uterotonics (e.g., oxytocin), IV fluids, comprehensive emergency obstetric care, blood transfusion and surgery

  • Cost-effectiveness [ Time Frame: 72 hours (plus or minus 8 hours) after delivery ] [ Designated as safety issue: No ]
    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.

  • Proportion of women reporting known side effects of misoprostol [ Time Frame: 1 hour after delivery ] [ Designated as safety issue: Yes ]
    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.

  • Acceptability of intervention to women [ Time Frame: 72 hours (plus or minus 8 hours) after delivery ] [ Designated as safety issue: No ]
    A brief exit interview will be conducted with participants to assess their acceptability of the intervention, including tolerability of any side effects experienced.


Estimated Enrollment: 3000
Study Start Date: December 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Primary prevention Drug: Misoprostol
Universal administration of 600 mcg oral misoprostol given to all women within 5 minutes of delivery of the baby
Secondary Prevention Drug: Misoprostol
Selective administration of 800 mcg sublingual misoprostol to women with at least 350 mL blood loss within 1 hour following delivery

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

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462422

Contacts
Contact: Sheila Raghavan, MSc 2124481230 sraghavan@gynuity.org
Contact: Holly A Anger, MPH 2124481230 hanger@gynuity.org

Locations
India
Deliveries at health sub-centers and homes Recruiting
Bijapur, Karnataka, India, 586103
Contact: Shivaprasad S Goudar, MD, MHPE    +91 831 244 4444 ext 4063    sgoudar@jnmc.edu   
Contact: Mallikarjun C Yadavannavar    09448816783    mcyadavannavar@gmail.com   
Principal Investigator: Shivaprasad S Goudar, MD, MHPE         
Sub-Investigator: Mrutyunjaya Bellad, MD         
Sub-Investigator: Shaila R Bidari, MD         
Sponsors and Collaborators
Gynuity Health Projects
Sri B. M. Patil Medical College, Bijapur, Karnataka, India
Jawaharlal Nehru Medical College
University of Illinois at Chicago
University of California, San Francisco
Investigators
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Principal Investigator: Sheila Raghavan, MSc Gynuity Health Projects
Principal Investigator: Stacie Gellar, PhD University of Illinois at Chicago
Principal Investigator: Suellen Miller, PhD, CNM University of California, San Francisco
Principal Investigator: Shivaprasad S Goudar, MD, MHPE Jawaharlal Nehru Medical College
  More Information

Additional Information:
No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01462422     History of Changes
Other Study ID Numbers: 2.4.16
Study First Received: October 27, 2011
Last Updated: June 27, 2013
Health Authority: India: Indian Council of Medical Research
United States: Institutional Review Board

Keywords provided by Gynuity Health Projects:
Postpartum hemorrhage
Prevention
Misoprostol
Developing countries
Nurse midwife

Additional relevant MeSH terms:
Puerperal Disorders
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Uterine Hemorrhage
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on April 15, 2014