Misoprostol+Oxytocin vs. Carbetocin in CS

Study Overview
=================
Brief Summary
-----------------
This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.

Official Title
-----------------
Adjuvant Use of Misoprostol and Oxytocin vs. Carbetocin for the Prevention of Post-partum Hemorrhage in Elective Cesarian Section

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: Oxytocin
* Drug: Carbetocin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks). Exclusion Criteria: hypersensitivity to oxytocin, carbetocin or prostaglandins contraindication to prostaglandins (e.g. glaucoma) history of significant heart disease severe asthma epilepsy history or evidence of liver renal or vascular disease history of coagulopathy thrombocytopenia or anticoagulant therapy women with HELLP syndrome eclampsia women presenting by placental abruption contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol + Oxytocin<br>400 ug sublingual misoprostol + 10 IU Oxytocin IVI | Drug: Misoprostol<br> <br> * Other names: Mesotac;Drug: Oxytocin<br> <br> * Other names: Syntocinon;Drug: Placebo<br> <br> |
| Active Comparator: Carbetocin<br>100 ug Carbetocin IV | Drug: Carbetocin<br> <br> * Other names: Pabal;Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of post-partum hemorrhage |  | 24 hours | 
| amount of blood loss |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants needing extra uterotonic drug (10 IU oxytocin IVI) | An experienced attendant (principal investigator) will assess the need of extra uterotonic drug (10 IU oxytocin IVI) if the uterus is atonic or if blood loss is more than 1000 ml. | 24 hours | 
| Number of participants needing hemostatic surgical interventions |  | intra-operative | 
| Hemoglobin deficit in gm/dl | difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl | 24 hours | 
| APGAR score at 1 minute and 5 minutes |  | 1 minute and 5 minutes | 
| Number of participants with NICU admission |  | 24 hours | 
| Drug side effects |  | 24 hours | 
| Time till resuming bowel habits | Time of passing gas will be recorded how many hours post-operative | 24 hours | 
| hematocrit deficit in % | difference between pre-operative and 24 hours post-operative hematocrit in % | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Misoprostol, Oxytocin, Carbetocin, Prevention, Post-partum hemorrhage