Intraumbilical Misoprostol in Retained Placenta

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Retained Placenta

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol<br>4 misoprostol tablets (Misotac® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein | Drug: Misoprostol<br>* It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance.<br>* Other names: (Misotac)® tablet;|
| Placebo Comparator: Normal saline<br>Normal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta | Drug: Normal saline<br>* It is a placebo group<br>* Other names: Normal saline 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraumbilical misoprostol, Retained placenta, Active management of third stage of labour