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Completed

NCT Number: NCT01485562

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

A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan.

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Key information

About this study

A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan. The purpose of the study is to assess the overall clinical and programmatic effectiveness of Traditional Birth Attendants (TBAs) administering 800 mcg sublingual misoprostol to treat Postpartum Haemorrhage (PPH) at the community level.

The study will recruit pregnant women who deliver at home. All women enrolled in the study will receive misoprostol for prevention (600 mcg oral dose). Women diagnosed with PPH will be randomized to receive either a) standard care + 800 mcg sublingual misoprostol (four 200 mcg tablets) or b) standard care + four placebo tablets resembling misoprostol. In this setting, standard care is uterine massage and/or compression and referral to the nearest health facility or attendance by the Lady Health Visitor/ Community Health Nurse.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women who deliver at home with a study TBA present.
  • Women must be willing and able to provide informed consent
  • Women must agree to participate in a follow up interview
  • Women must agree to have pre and post-partum haemoglobin taken

Exclusion criteria

  • If the woman does not meet any of the above outlined inclusion criteria

Treatment and study plan

Misoprostol

Drug

4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth

Other names: Gymiso

Placebo

Other

4 tablets, administered sublingually if the woman experiences a PPH

Other names: Gymiso

Primary outcomes

  1. Haemoglobin concentration (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.

Secondary outcomes

  1. Number of participants who experience side effects

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

    number of women who experienced side effects and the severity of the side effects as rated on a scale, additional care provided

  2. number of participants who received additional interventions

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

    number of participants who received care by as skilled provider and the type of care provided

  3. number of women who found misoprostol treatment to be acceptable

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

    women will be asked to rate their acceptability with the treatment using a scale

  4. number of participants who experience severe adverse events

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

    serious adverse are defined as uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Aga Khan Health Services

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2011
Registry last updated
Mar 10, 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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