Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage

Study Overview
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Brief Summary
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Comparison between Carbetocin and Oxytocin as prophylaxis against Primary Postpartum Hemorrhage.

Detailed Description
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Patients will be allocated randomly by simple randomization into either 1- the control group which will be given 10 IU oxytocin intravenously, OR 2- the treatment group which will be given 100 micrograms of carbetocin intravenously. The trial will be conducted on patients with high risk of developing atonic primary postpartum hemorrhage. The trial will be single blinded. All patients fulfilling the inclusion criteria undergoing elective Caesarean section will be approached by the treating physician and will be asked to participate in the study. An informed written consent will be taken from each patient. The data collected will include base line characteristics such as age, parity, body mass index, the risk for Postpartum hemorrhage in each patient, amount of blood loss, blood units given, complete blood picture (pre and post operative) and coagulation profile.

Official Title
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Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage in High-risk Patients in Sohag University Hospital: A Randomized Controlled Clinical Trial

Conditions
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Atonic Postpartum Hemorrhage, High Risk Pregnancy

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Carbetocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • High risk patients for post-partum hemorrhage who will subjected to Caeserean section either elective or in labour at or after 36 weeks of gestation. This should include one or more of the following: History of postpartum hemorrhage. Delivery of a macrosomic baby (> 4000 g). Multiple gestation. Polyhydramnios. Grand Multiparity. Interstitial or submucous fibroid. (Single larger than 4 cm or Multiple myomata) Chorioamnionitis. Exclusion Criteria: • Patients without high risk for post-partum hemorrhage. Patients at high risk for postpartum hemorrhage but will deliver vaginally. Patients with medical disorders complicating pregnancy. Patients with coagulation defects. Preterm pregnancies.

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trial (Simple randomization)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin<br>the control group will be given 10 iu intravenously. | Drug: Oxytocin<br>* 10 iu will be given intravenously.<br>|
| Active Comparator: Carbetocin<br>the treatment group will be given 100 microgram intravenously. | Drug: Carbetocin<br>* 100 micrograms will be given intravenously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Postpartum Hemorrhage | Amount of Blood Loss in milliliters. Pre-operative patient's Hemoglobin (Hb) level and 24 hours post-operative will be assessed to quantify amount of blood loss. Additionally, all towels prepared for CS will weighed, and the weight will be marked on each pack before autoclaving. All towels (used and unused) will be weighed again after use, and a difference of 1 gm will be considered as equivalent to 1 mL of absorbed blood. | First 24 hours after Delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atonic Postpartum Hemorrhage, Carbetocin, Oxytocin, High Risk Pregnancy