The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery

Not Applicable

Completed

• Conditions: Cesarean Section Complications; Postoperative Pain; Atony, Uterine; Postpartum Hemorrhage; Blood Loss, Surgical; Blood Loss, Postoperative
• Interventions: Other: after clamping the umbilical cord oxytocin; Other: before uterine incision oxytocin

• Registration Number: NCT03967171
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

This study compares the effect of starting intravenous oxytocin infusion early before uterine incision versus late after umbilical cord clamping on the blood loss during elective cesarean section

Detailed Description

Postpartum hemorrhage (PPH) is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. The average blood loss during cesarean section is 1000 ml which is nearly double the blood loss during vaginal delivery. Worldwide, the most commonly used uterotonic for the prevention of PPH is oxytocin. Several regimens of oxytocin have been tested during cesarean section with variable wanted (uterotonic) and unwanted (cardiovascular) effects. In the current study, we tested the hypothesis that initiating IV oxytocin infusion earlier before uterine incision would induce a rapid acceptable uterine contraction and minimize the intraoperative blood loss than the same dose administered after delivery of the fetus.

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Primary Completion: 2019-06-20
• Study Completion: 2019-07-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

Inclusion Criteria

• single fetus at term >37 weeks of gestational age

Exclusion Criteria

• history of previous cesarean section
• history of previous uterine surgery
• multiple gestation, placenta previa, polyhydramnious, fetal macrosomia
• women at high risk for uterine atony such as anemia (Hb < 8 gm/dL)
• uterine atony history
• gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
after clamping the umbilical cord oxytocin group	after clamping the umbilical cord oxytocin	IV infusion of 20 IU of oxytocin started immediately after clamping the umbilical cord
before uterine incision oxytocin group	before uterine incision oxytocin	IV infusion of 20 IU of oxytocin started before uterine incision

Primary Outcome Measures

Name	Time	Method
blood loss during elective cesarean section	2 hours	The intraoperative blood loss will be measured by adding the volume of the suction bottle with the blood soaked sponges (know dry weight). The blood loss was estimated after excluded amniotic fluid volume in the suction bottle in each case

Secondary Outcome Measures

Name	Time	Method
postoperative blood loss	24 hours	The hemoglobin and hematocrit values will be measured 24 hours after CS

Trial Locations

Locations (1)

Bezmialem Vakıf University Hospital; 🇹🇷 Istanbul, Turkey