Misoprostol in the Treatment of Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

Misoprostol in the Treatment of Post Partum Hemorrhage: A Placebo Randomised Controlled Trial in 4 Karachi Hospitals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116480
• Other study ID #: 2.4.2
• Status: Completed
• Phase: N/A
• First received: June 29, 2005
• Last updated: March 17, 2009
• Start date: December 2005
• Est. completion date: April 2007

Study information

• Verified date: March 2009
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All women delivering vaginally with clinically diagnosed PPH requiring uterotonics

Exclusion Criteria:

• Refusal to give consent for participation or if the woman is too distressed to give consent

• Woman is not entitled to give informed consent (e.g. minors without a guardian)

• Woman who had a caesarean section

• Delivery is regarded as abortion (gestational age < 28 weeks)

Study Design

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
600 mcg of sublingual misoprostol

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi
Pakistan	The Aga Khan Health Services	Karachi

Sponsors (5)

Lead Sponsor	Collaborator
Gynuity Health Projects	Aga Khan Health Services, Aga Khan University, Family Care International, The Aga Khan Foundation

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss greater than or equal to 500 mls after enrolment		Blood loss measured for minimum of 1 hour or until active bleeding ceased	Yes
Secondary	Average blood loss		Blood loss measured for minimum of one hour or until active bleeding ceased	Yes
Secondary	Clinical complications (need for transfusion, hysterectomy)		After delivery and prior to hospital discharge	Yes
Secondary	Pre-delivery and post-delivery hemoglobin measures		Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery	Yes
Secondary	Side effects		observed or reported following study treatment and prior to discharge	Yes

External Links

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