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

Postpartum Haemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485562
• Other study ID #: 2.4.15
• Status: Completed
• Phase: N/A
• First received: December 1, 2011
• Last updated: March 9, 2016
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan:Ethical Review Committee, Aga Khan University
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Haemorrhage
• Postpartum Hemorrhage

Intervention

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

Other:
• placebo
4 tablets, administered sublingually if the woman experiences a PPH

Locations

Country	Name	City	State
Pakistan	Home Births	Chitral	Khyber Pakhtunkhwa

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Aga Khan Health Services

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin concentration (Hb) of greater than or equal to 2 g/dl from pre- to post-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.	3-5 days after delivery	No
Secondary	Number of participants who experience side effects	number of women who experienced side effects and the severity of the side effects as rated on a scale, additional care provided	immediately after delivery; 3-5 days post delivery	Yes
Secondary	number of participants who received additional interventions	number of participants who received care by as skilled provider and the type of care provided	immediately after delivery; 3-5 days post delivery	Yes
Secondary	number of women who found misoprostol treatment to be acceptable	women will be asked to rate their acceptability with the treatment using a scale	immediately after delivery; 3-5 days post delivery	No
Secondary	number of participants who experience severe adverse events	serious adverse are defined as uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.	immediately after delivery; 3-5 days post delivery	Yes