Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births
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|ClinicalTrials.gov Identifier: NCT01485562|
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : March 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Haemorrhage||Drug: Misoprostol Other: placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: Misoprostol
women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually)
4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth
Other Name: Gymiso
Placebo Comparator: placebo
women who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually
4 tablets, administered sublingually if the woman experiences a PPH
Other Name: Gymiso
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485562
|Chitral, Khyber Pakhtunkhwa, Pakistan|
|Principal Investigator:||Zafar Khan||Aga Khan Health Services|
|Study Director:||Nadeem Zuberi||Aga Khan University|
|Study Director:||Gijs Walraven||Secretariat of His Highness the Aga Khan, Aiglemont|
|Study Director:||Ayisha Diop||Gynuity Health Projects|
|Study Director:||Dina Abbas||Gynuity Health Projects|