Two Different Regimens of Misoprostol in Retained Placenta

Hawler Medical University509 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

509

Conditions

Postpartum Haemorrhage Retained Placenta

Interventions

MisoprostolDRUG

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

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hawler Medical university

Erbil, Kurdistan Region, Iraq

Outcomes

Primary Outcomes

Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol

complete delivery of placenta after injection of intraumbilical misoprostol

Time frame: up to 30 minutes after intraumbilical injection

Secondary Outcomes

The amount of blood loss vaginally in both groups

To estimate the amount of vaginal blood loss from time of injection of the the interventional drug and till the delivery of the placenta

Time frame: up to 30 minutes after injection of placenta

The time of delivery of placenta in both groups

the time interval estimation from the injection to complete delivery of the placenta

Time frame: up to 30 minutes after delivery of the placenta

side effects of misoprostol

Any side effects related to misoprostol after the injection (Fever, severing , diarrhea)

Time frame: up to 24 hours after delivery of placenta

Data from ClinicalTrials.gov

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