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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Gynuity Health Projects

Current Primary Outcome: 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.


Original Primary Outcome: haemoglobin concentration (Hb) of greater than 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.


Current Secondary Outcome:

  • 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
  • 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
  • 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
  • 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.


Original Secondary Outcome: side effects, additional interventions, and acceptability [ Time Frame: immediately after delivery; 3-5 days post delivery ]

Observed side effects: perceived severity, additional care provided Correct administration of prophylaxis, correct administration of misoprostol for treatment Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.

Postpartum Hb, mean difference in postpartum Hb levels between treatment groups, persistent bleeding following study treatment

# of referrals and transfers Woman's condition at time of referral and at time of transfer Additional interventions Acceptability and management of side effects



Information By: Gynuity Health Projects

Dates:
Date Received: December 1, 2011
Date Started: May 2012
Date Completion:
Last Updated: March 9, 2016
Last Verified: March 2016