Two Different Regimens of Misoprostol in Retained Placenta

Study Overview
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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

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

Official Title
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Umbilical Vein Injection of 800µg Misoprostol Versus 400 µg Misoprostol in the Treatment of Retained Placenta: A Multicenter, Randomized Double Blind Controlled Trial

Conditions
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Postpartum Haemorrhage, Retained Placenta

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 400 Microgram Misoprostol<br>Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group | Drug: Misoprostol<br>* 2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women<br>* Other names: Cytotic;|
| Active Comparator: 800 Microgram Misoprostol<br>Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group | Drug: Misoprostol<br>* 2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women<br>* Other names: Cytotic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 30 minutes after intraumbilical injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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) | up to 24 hours after delivery of placenta | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemorrhage, Retained placenta, Misoprostol, double blind, Randomization