Two Different Regimens of Misoprostol in Retained Placenta

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

PHASE2

Total Enrollment

509 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-02-14

Brief Summary

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This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia

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Detailed Description

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The third stage of labor may be complicated by retained placenta, which may cause severe bleeding and infection, with a potentially fatal outcome. Manual removal of placenta is the current standard of management of retained placenta which usually requires general or regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding, trauma and infection. Intraumbilical injection of uterotonic agent( misoprostol) is an easy, non invasive procedure. A randomized clinical trial are required to determine the difference between two doses of misoprostol 400 versus 800 micro gram for management of retained placenta

Conditions

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Postpartum Haemorrhage Retained Placenta

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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400 Microgram Misoprostol

Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women

800 Microgram Misoprostol

Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women

Interventions

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Misoprostol

2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women

Intervention Type DRUG

Other Intervention Names

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Cytotic

Eligibility Criteria

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Inclusion Criteria

* women with a singleton pregnancy, delivered vaginally
* 28 weeks of gestation and more,
* had a prolonged third stage of labor (more than 30 minutes) despite active management,
* Haemodynamically stable and accept to participate in the trial

Exclusion Criteria

* multiple pregnancies,
* previous caesarean delivery,
* haemodynamically instability, severe anaemia (haemoglobin concentration \<8 g/dL),
* chorioamnionitis
* Refused to participate in the trial

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes