Trial | NCT01485562  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    misoprostol ...

  • Study Participants

    84
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.
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.
Study Started
May 31
2012
Primary Completion
Dec 31
2014
Study Completion
Dec 31
2014
Last Update
Mar 10
2016
Estimate

Drug Misoprostol

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

  • Other names: Gymiso

Other placebo

4 tablets, administered sublingually if the woman experiences a PPH

  • Other names: Gymiso

Misoprostol Active Comparator

women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually)

placebo Placebo Comparator

women who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually

Criteria 

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
No Results Posted