Intraumbilical Misoprostol in Retained Placenta

Phase 1

Completed

• Conditions: Retained Placenta
• Interventions: Drug: Misoprostol; Drug: Normal saline

• Registration Number: NCT01840813
• Lead Sponsor: Hawler Medical University

Brief Summary

Administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta and the amount of blood loss vaginally.

Detailed Description

Retained placenta (RP)is one of the complications of third stage of labour; it should be managed promptly as it may cause severe bleeding, infection, maternal morbidity and mortality .The current standard management of RP word wide, by manual removal aims to prevent these problems, but it is unsatisfactory method because it requires general anaesthesia in hospital, It is an invasive procedure with its own serious complications of bleeding, infection and genital tract injury. Umbilical vein injection of misoprostol is a simple, safe method and could be performed at the place of delivery .

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-26
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-01
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

• women having singleton pregnancy
• 28 weeks of gestation or more delivered vaginally
• prolongation of the third stage of labour (more than 30 min) following active management of third stage of labour

Exclusion Criteria

• Who refused to participate in the trial
• Multiple pregnancies
• Previous Caesarean Section
• Haemodynamically unstable
• Severe anaemia (haemoglobin less than 8gm/dl)
• Chorioamnionitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol	Misoprostol	4 misoprostol tablets (Misotac® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein
Normal saline	Normal saline	Normal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta

Primary Outcome Measures

Name	Time	Method
delivery of placenta by medical intervention	30 minutes after the injection of misoprostol or normal saline in the umbilical vein	The administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta under general anaesthesia.

Secondary Outcome Measures

Name	Time	Method
vaginal bleeding after misoprostol use	30 minutes after umbilical vein injection of misoprostol	using intraumbilical misoprostol in women with retained placenta reduces the amount of blood loss vaginally.

Trial Locations

Locations (1)

Maternity Teaching Hospital; 🇮🇶 Erbil city, Kurdistan region, Iraq