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Postpartum HemorrhageNCT01462422

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

A study testing Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Hemorrhage
What is being tested?
Misoprostol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,032 participants
Where
1 siteIndia
Study dates
Dec 2011to Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 1. high-risk pregnancy

Trial locations and contacts

1 site in 1 country.

India1 site

  • Deliveries at health sub-centers and homes

    Vijayapura, Karnataka, 586103

Other trials in India

About this study

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

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.

Read the 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.

Being tested
Misoprostol
Keywords
Postpartum hemorrhage, Prevention, Misoprostol, Developing countries, Nurse midwife
Medical subject headings
Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MisoprostolDrug

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

  • MisoprostolDrug

    Universal administration of 600 mcg oral misoprostol given to all women within 5 minutes of delivery of the baby

Study groups in NCT01462422
Study groupRoleWhat they receive
Primary preventionOtherNot described
Receives: Drug: Misoprostol
Secondary PreventionOtherNot described
Receives: Drug: Misoprostol

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 72 hours (plus or minus 8 hours) after delivery

Secondary outcomes (9)

  1. Rate of transfer to referral facilities for PPH

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

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

  2. Rate of PPH

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

    Measured: within 1 hour after delivery

  3. Rate of severe PPH

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

    Measured: within 1 hour after delivery

  4. Rate of adverse events

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

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

  5. Mean blood loss

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

    Measured: 1 hour after delivery

  6. Rate of additional interventions needed to control bleeding

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

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

  7. Cost-effectiveness

    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.

    Measured: 72 hours (plus or minus 8 hours) after delivery

  8. Proportion of women reporting known side effects of misoprostol

    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.

    Measured: 1 hour after delivery

  9. Acceptability of intervention to women

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

    Measured: 72 hours (plus or minus 8 hours) after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,032 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01462422
Sponsor's protocol ID
2.4.16
Status last verified
Jun 2014
First submitted
27 Oct 2011
Last updated
16 Jun 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33232518

Questions about this trial

What is this clinical trial studying?

A study testing Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of women with post-delivery hemoglobin ≤ 7.8 gm/dL (time frame: 72 hours (plus or minus 8 hours) after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01462422, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2014.

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