Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery

Study Overview
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Brief Summary
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Researchers sought to see how oxytocin versus, sublingual misoprostol affected estimated and measured blood loss during vaginal delivery in women who had blood loss >300 ml .

Detailed Description
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The greatest cause of maternal mortality globally is postpartum hemorrhage (PPH), which is defined as a blood loss of 500 mL or more after birth. All women giving birth should be given a preventive uterotonic drug, according to the World Health Organization (WHO). Despite the use of a uterotonic drug as a preventative measure, PPH remains a frequent complication, accounting for one-quarter of all maternal fatalities worldwide. When prophylaxis fails and PPH develops, it is advised that uterotonic medicines be used as first-line therapy. However, it's unclear whether the uterotonic drug is better for treating PPH as first-line therapy.

Official Title
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The Effect of Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery: a Randomized Controlled Trial

Conditions
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Labor Complication

Intervention / Treatment
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* Drug: oxytocin
* Drug: misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vaginal birth in women who had blood loss >300 ml Exclusion Criteria: <37 weeks of pregnancy, genital tract injuries, coagulation deficit, hypertension, preeclampsia, cardiac, renal, or hepatic disease, epilepsy,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blinded a randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oxytocin<br>20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland) | Drug: oxytocin<br>* 20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)<br>* Other names: Active Comparator;|
| Experimental: misoprostol<br>800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA) | Drug: misoprostol<br>* 800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)<br>* Other names: Active Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measured excessive bleeding blood loss ≥ 300 mills after PPH treatment | measured amount of blood loss ≥ 300 mills after PPH treatment | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in hemoglobin | measure change of hemoglobin | 12 hours | 
| need for additional interventions | number of patients need additional interventions ,like uterine aetry ligation | 24 hours |