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

NCT03967171 | Completed

• 1 other identifier: BezmialemVU Oxytocin effect
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Oxytocin; cesarean section; uterine atony; Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• postoperative blood loss

  24 hours

Other Outcomes (2)

• postoperative pain score

  24 hours

• neonatal wellbeing

  2 hours

Study Arms (2)

before uterine incision oxytocin group

EXPERIMENTAL

IV infusion of 20 IU of oxytocin started before uterine incision

Other: before uterine incision oxytocin

after clamping the umbilical cord oxytocin group

ACTIVE COMPARATOR

IV infusion of 20 IU of oxytocin started immediately after clamping the umbilical cord

Other: after clamping the umbilical cord oxytocin

Interventions

before uterine incision oxytocin OTHER

blood loss during elective cesarean section

before uterine incision oxytocin group

after clamping the umbilical cord oxytocin OTHER

blood loss during elective cesarean section

after clamping the umbilical cord oxytocin group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• single fetus at term \>37 weeks of gestational age

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University Hospital

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage; Pain, Postoperative; Uterine Inertia

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms; Dystocia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: May 1, 2019
• Primary Completion: June 20, 2019
• Study Completion: July 1, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)