Clinical trial NCT00116480: Misoprostol in the Treatment of Postpartum Hemorrhage
Official title: Misoprostol in the Treatment of Post Partum Hemorrhage: A Placebo Randomised Controlled Trial in 4 Karachi Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Postpartum Haemorrhage
Misoprostol
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Aga Khan University
name: Aga Khan Health Services
name: The Aga Khan Foundation
name: Family Care International
First posted: 2005-06-30
Enrollment: 61
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Blood loss greater than or equal to 500 mls after enrolment
timeFrame: Blood loss measured for minimum of 1 hour or until active bleeding ceased
Secondary outcomes:
measure: Average blood loss
timeFrame: Blood loss measured for minimum of one hour or until active bleeding ceased
measure: Clinical complications (need for transfusion, hysterectomy)
timeFrame: After delivery and prior to hospital discharge
measure: Pre-delivery and post-delivery hemoglobin measures
timeFrame: Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery
measure: Side effects
timeFrame: observed or reported following study treatment and prior to discharge
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
city: Karachi
country: Pakistan
facility: The Aga Khan Health Services
Study officials:
affiliation: Aga Khan University Hospital, Karachi
name: Nadeem F Zuberi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.
citation: Zuberi NF, Durocher J, Sikander R, Baber N, Blum J, Walraven G. Misoprostol in addition to routine treatment of postpartum hemorrhage: a hospital-based randomized-controlled trial in Karachi, Pakistan. BMC Pregnancy Childbirth. 2008 Aug 21;8:40. doi: 10.1186/1471-2393-8-40.