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OpenTrials
Completed

NCT Number: NCT01508429

Misoprostol for Treatment of Postpartum Haemorrhage (PPH) in Home Births

Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use.

A double-blinded individual randomized controlled study of misoprostol versus placebo in home deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit pregnant women who are likely to deliver at home. All women enrolled in the study will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of their baby (ies) and before delivery of the placenta.

Women who experience a PPH will be randomized to receive either: a) standard of care + 800 mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets resembling misoprostol. In this setting, standard of care is referral.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Home delivery setting

Darwaz, Ishkashim, Shugnan, Wakhan Districts, Badakshan Province, Afghanistan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women must be pregnant
  • Must be able to provide informed consent
  • Must agree to have a community health worker present at the time of delivery
  • Must agree to participate in a follow up interview by the study midwife
  • Must agree to have pre and postpartum haemoglobin taken

Exclusion criteria

  • Women who do not meet the inclusion criteria

Treatment and study plan

Placebo

Other

4 placebo tablets (resembling misoprostol) administered sublingually

Misoprostol

Drug

800mcg misoprostol (4 200mcg tablets administered sublingually)

Primary outcomes

  1. Hb of greater than or equal to 2 g/dl from pre- to post-delivery

    Time frame: 3-5 days after delivery

    The primary outcome will measure the proportion of women who experience a drop in their haemoglobin concentration (Hb) of greater than 2 g/dl from pre- to post-delivery. The outcome will be compared between the two treatment groups.

Secondary outcomes

  1. Side effects

    Time frame: immediately after delivery; 3-5 days post delivery

    Observed side effects: perceived severity, additional care provided Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.

  2. additional interventions

    Time frame: immediately after delivery; 3-5 days post delivery

    Additional interventions and additional care provided to the woman, # of referrals and transfers

  3. Acceptability

    Time frame: immediately after delivery; 3-5 days post delivery

    Acceptability and management of side effects, acceptablity of taking the drugs

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Aga Khan Health Services

Registry information

Official study title

Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries.

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 12, 2012
Registry last updated
Jul 11, 2016

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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