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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967171
• Other study ID #: BezmialemVU Oxytocin effect
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: September 2019
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 1, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Atony, Uterine
• Blood Loss, Postoperative
• Blood Loss, Surgical
• Cesarean Section Complications
• Hemorrhage
• Postoperative Hemorrhage
• Postoperative Pain
• Postpartum Hemorrhage
• Uterine Inertia

Intervention

Other:
• before uterine incision oxytocin
blood loss during elective cesarean section
• after clamping the umbilical cord oxytocin
blood loss during elective cesarean section

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative pain score	The Visual Analogue Scale (VAS) will be implemented postoperative day 0 and postoperative 1st day	24 hours
Other	neonatal wellbeing	Apgar scores (1 and 5 minutes) will be compared	2 hours
Primary	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	postoperative blood loss	The hemoglobin and hematocrit values will be measured 24 hours after CS	24 hours