NCT00116480

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

March 19, 2009

Status Verified

March 1, 2009

Enrollment Period

1.3 years

First QC Date

June 29, 2005

Last Update Submit

March 17, 2009

Conditions

Postpartum Hemorrhage

Keywords

Postpartum HaemorrhageMisoprostol

Outcome Measures

Primary Outcomes (1)

  • Blood loss greater than or equal to 500 mls after enrolment

    Blood loss measured for minimum of 1 hour or until active bleeding ceased

Secondary Outcomes (4)

  • Average blood loss

    Blood loss measured for minimum of one hour or until active bleeding ceased

  • Clinical complications (need for transfusion, hysterectomy)

    After delivery and prior to hospital discharge

  • 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

  • Side effects

    observed or reported following study treatment and prior to discharge

Study Arms (2)

Misoprostol

EXPERIMENTAL

three tablets of active misoprostol (600 mcg) given sublingually

Drug: Misoprostol

Placebo

PLACEBO COMPARATOR

three tablets resembling misoprostol given sublingually

Drug: Misoprostol

Interventions

MisoprostolDRUG

600 mcg of sublingual misoprostol

MisoprostolPlacebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All women delivering vaginally with clinically diagnosed PPH requiring uterotonics

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aga Khan University Hospital

Karachi, Pakistan

Location

The Aga Khan Health Services

Karachi, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 33232518DERIVED

  • 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.

    PMID: 18718007DERIVED

Related Links

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Nadeem F Zuberi, MD

    Aga Khan University Hospital, Karachi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2005

First Posted

June 30, 2005

Study Start

December 1, 2005

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

March 19, 2009

Record last verified: 2009-03

Locations

PA(2)