Intraumbilical Misoprostol in Retained Placenta

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01840813

Enrollment

Registered

2013-04-26

Start date

2011-04-30

Completion date

2012-03-31

Last updated

2013-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retained Placenta

Keywords

Intraumbilical misoprostol, Retained placenta, Active management of third stage of labour

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 .

Interventions

DRUGMisoprostol

It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance.

DRUGNormal saline

It is a placebo group

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Number of Participants with Adverse Events as a Measure of Safety and Tolabrity	2 hours after umbilical vein injection of misoprostol	Local applications of misoprostol through umbilical vein is associated with less side effects like shivering, fever, dizziness vomiting, flushes, nausea, abdominal pain and headache

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026