Back to resultsOxytocin Administration During Cesarean Section
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Primigravida or multigravida
- Term (37 - 42 weeks),
- Singleton pregnancies
- Booked for elective caesarean section.
- Accepting to participate in the study.
Exclusion Criteria:
• Medical disorders involving the heart, liver, kidney or brain.
- Diabetes mellitus and hypertension.
- Blood disorders (e.g. coagulopathies, thrombocytopenia)
- Patients requiring blood transfusion due to anemia.
- Risk factors for uterine atony e.g. macrosomia, polyhydramnios and multiple pregnancy.
- Previous 2 or more cesarean section
- Placenta previa or placental abruption
- Previous major obstetric haemorrhage (>1000 ml) in previous deliveries.
- Known fibroid or adenomyosis.
- Women who received anticoagulant therapy.
- Severe preeclampsis.
- Uterine anomalies.
Sites / Locations
- Assiut Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group
Control group
Arm Description
100 women were assigned to receive an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour minutes diluted into 500 mL of normal 0.9% sodium chloride) immediately after opening the visceral peritoneum just before incising the uterine wall during Cesarean section
100 women were assigned to an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour diluted into 500 mL of normal 0.9% sodium chloride) immediately after clamping the umbilical cord during cesarean section
Outcomes
Primary Outcome Measures
rate of blood loss
collection of the blood in the drape below the patient
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03344302
Brief Title
Oxytocin Administration During Cesarean Section
Official Title
Oxytocin Administration During Cesarean Section Before Versus After Fetal Delivery Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall. This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy The guidelines of the Royal College of Obstetricians and Gynaecologists on caesarean section recommend a slow intravenous bolus dose of 5 IU of oxytocin after delivery of the infant. Intravenous oxytocin has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin infusion at caesarean section is in maintaining uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhage occurs
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
100 women were assigned to receive an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour minutes diluted into 500 mL of normal 0.9% sodium chloride) immediately after opening the visceral peritoneum just before incising the uterine wall during Cesarean section
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
100 women were assigned to an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour diluted into 500 mL of normal 0.9% sodium chloride) immediately after clamping the umbilical cord during cesarean section
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
intravenous infusion of oxytocin 30 units over 5 minutes diluted into 500 mL of normal 0.9% sodium chloride
Primary Outcome Measure Information:
Title
rate of blood loss
Description
collection of the blood in the drape below the patient
Time Frame
4 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primigravida or multigravida
Term (37 - 42 weeks),
Singleton pregnancies
Booked for elective caesarean section.
Accepting to participate in the study.
Exclusion Criteria:
• Medical disorders involving the heart, liver, kidney or brain.
Diabetes mellitus and hypertension.
Blood disorders (e.g. coagulopathies, thrombocytopenia)
Patients requiring blood transfusion due to anemia.
Risk factors for uterine atony e.g. macrosomia, polyhydramnios and multiple pregnancy.
Previous 2 or more cesarean section
Placenta previa or placental abruption
Previous major obstetric haemorrhage (>1000 ml) in previous deliveries.
Known fibroid or adenomyosis.
Women who received anticoagulant therapy.
Severe preeclampsis.
Uterine anomalies.
Facility Information:
Facility Name
Assiut Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Oxytocin Administration During Cesarean Section
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