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

The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery: a Randomised Controlled Trial

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Bezmialem Vakıf University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: before uterine incision oxytocin group; IV infusion of 20 IU of oxytocin started before uterine incision	Other: before uterine incision oxytocin; blood loss during elective cesarean section
Active Comparator: after clamping the umbilical cord oxytocin group; IV infusion of 20 IU of oxytocin started immediately after clamping the umbilical cord	Other: after clamping the umbilical cord oxytocin; blood loss during elective cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood loss during elective cesarean section	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	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative blood loss	The hemoglobin and hematocrit values will be measured 24 hours after CS	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain score	The Visual Analogue Scale (VAS) will be implemented postoperative day 0 and postoperative 1st day	24 hours
neonatal wellbeing	Apgar scores (1 and 5 minutes) will be compared	2 hours

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Oxytocin; cesarean section; uterine atony; Postpartum Hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Intraoperative Complications; Dystocia; Hemorrhage; Postpartum Hemorrhage; Uterine Inertia; Blood Loss, Surgical; Postoperative Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: BezmialemVU Oxytocin effect

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No