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

Phase 4

Completed

• Conditions: Postpartum Haemorrhage; ıntrapartum Haemorrhage
• Interventions: Drug: Misoprostol

• Registration Number: NCT01931410
• Lead Sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-28
• Study First Posted: 2013-08-29
• Primary Completion: 2014-01
• Status Verified: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 618

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sublingual	Misoprostol	400 microgram mısoprostol will be administered sublıngually before elective caesarean
rectal	Misoprostol	rectal 600 mgr misoprostol will be administered

Primary Outcome Measures

Name	Time	Method
Postpartum Haemorrhage	postpartum 24 hour