Intraumbilical Misoprostol in Retained Placenta

Retained Placenta Clinical Trial

Official title:

Intra-umbilical Injection of Misoprostol Versus Normal Saline in the Management of Retained Placenta: Intrapartum Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840813
• Other study ID #: HMU911
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2013
• Last updated: November 1, 2013
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: November 2013
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iraq: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Placenta, Retained
• Retained Placenta

Intervention

Drug:
• Misoprostol
It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance.
• Normal saline
It is a placebo group

Locations

Country	Name	City	State
Iraq	Maternity Teaching Hospital	Erbil city	Kurdistan region

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events as a Measure of Safety and Tolabrity	Local applications of misoprostol through umbilical vein is associated with less side effects like shivering, fever, dizziness vomiting, flushes, nausea, abdominal pain and headache	2 hours after umbilical vein injection of misoprostol	Yes
Primary	delivery of placenta by medical intervention	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.	30 minutes after the injection of misoprostol or normal saline in the umbilical vein	Yes
Secondary	vaginal bleeding after misoprostol use	using intraumbilical misoprostol in women with retained placenta reduces the amount of blood loss vaginally.	30 minutes after umbilical vein injection of misoprostol	Yes