Misoprostol in the Prevention of Postpartum Haemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1496 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective cohort

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double Blind Randomised Control Trial

Study Groups

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Intervention

200 micrograms of Misoprostol applied sublingually together with standard parenteral oxytocic therapy

Group Type ACTIVE_COMPARATOR

200 micrograms of misoprostol

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

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

Interventions

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200 micrograms of misoprostol

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

Intervention Type DRUG

Placebo Oral Tablet

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pregnant women admitted to the labour wards at University Hospital of the West Indies (UHWI) and Victoria Jubilee Hospital (VJH) undergoing a vaginal delivery
* Consent given to participate in the study

Exclusion Criteria

* Women undergoing caesarean section
* Gestational age less than 28 weeks
* Any severe allergic conditions
* Severe asthmatics
* Age \<16 years
* Temperature \>38 degrees Celsius
* Women not wishing to consent to join the study

Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes