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Misoprostol in the Prevention of Postpartum Haemorrhage

NCT04044287 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1496

Last updated 2019-08-05

No results posted yet for this study

Summary

Postpartum haemorrhage is a major contributor to maternal mortality in the developing world. The incidence is between 5 and 12% in Jamaica and varies depending on the route of delivery. Misoprostol is a uterotonic agent which has the potential to augment the effects of the standard parenteral oxytocic agents used as best practice in the active management of the third stage of labour, thereby reducing the risk of postpartum haemorrhage and its attendant complications.

The Aim of the study is twofold: to show that this additive effect translates to a reduced postpartum haemorrhage rate and secondly to demonstrate reduced side effects of misoprostol resulting from the lower dose and the powdered sublingual administration.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

200 micrograms of misoprostol

200 micrograms of powdered misoprostol applied sublingually together with standard parenteral oxytocic therapy

DRUG

Placebo Oral Tablet

200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy

Sponsors & Collaborators

  • The University of The West Indies

    lead OTHER

Principal Investigators

  • Rattray Dr Carole · University of the West Indies Mona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Jamaica

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04044287 on ClinicalTrials.gov