Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-01-31

Brief Summary

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Sublingual misoprostol produces rapid peak concentration and is more effective than oral misoprostol for prevention of excessive postpartum bleeding. The study hypothesis was to test whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage have 30 ml less average blood loss than women receiving oxytocin, the standard of care for prevention of postpartum hemorrhage. We conducted a Double blind randomized controlled trial of .652 consenting, eligible pregnant women admitted to the labor room of the teaching hospital at J N Medical College, Belgaum, India. Women participating in the study were assigned by computer generated randomization to receive the study medications and placebos within one minute after clamping and cutting the umbilical cord. We also looked at the drugs effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the percent of women experiencing more than a 10% decline in haemoglobin, and reported drug side effects.

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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

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Sublingual misoprostol

400 µg powdered misoprostol administered sublingually; IM placebo

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

400 µg sublingual misoprostol

Oxytocin

10 IU IM oxytocin; placebo powder

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

10 IU IM

Interventions

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Misoprostol

400 µg sublingual misoprostol

Intervention Type DRUG

Oxytocin

10 IU IM

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women with a gestational age \>28weeks
* singleton pregnancy with cephalic presentation anticipating a normal spontaneous vaginal delivery (including episiotomy)
* a haemoglobin ≥ 8g/dl upon presentation who were admitted to labour room in the KLE teaching hospital attached to J N Medical College, Belgaum

Exclusion Criteria

* Women with pregnancy induced hypertension
* antepartum haemorrhage
* previous caesarean section or presence of uterine scar
* diagnosed chorioamnionitis
* oxytocin induction or augmentation of labour
* intrauterine death
* diagnosed medical disorders (such as diabetes, cardiac, renal and hepatic diseases, etc.) or those in active labour (defined as \>4 cm dilatation)

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No