The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial

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

PHASE4

Total Enrollment

618 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-02-28

Brief Summary

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The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage.

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Detailed Description

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Conditions

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ıntrapartum Haemorrhage Postpartum Haemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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sublingual

400 microgram mısoprostol will be administered sublıngually before elective caesarean

Group Type PLACEBO_COMPARATOR

Misoprostol

Intervention Type DRUG

rectal

rectal 600 mgr misoprostol will be administered

Group Type PLACEBO_COMPARATOR

Misoprostol

Intervention Type DRUG

synpitan

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Misoprostol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. live and singleton pregnancy
2. Elective caesarean
3. Gestational week greater than 37 weeks
4. patient between 18-44 year old

Exclusion Criteria

1. -multiple pregnancy
2. Preeclampsia
3. Gestational diabetes
4. Macrosomia
5. Oligohidraamnıos
6. Polihidraamnıos
7. Myoma
8. Morbid obesity
9. Coagulatıon defect (such as HELLP syndrome)

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No