IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Oxytocin

• Registration Number: NCT01608958
• Lead Sponsor: Gynuity Health Projects

Brief Summary

The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.

Detailed Description

The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-31
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-25
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 653

Inclusion Criteria

• All women who present in active labor for a live birth at the study hospital will be considered for participation in the study

Exclusion Criteria

Women who are:

• Planned or transferred for delivery via Cesarean section
• Not delivering a live birth
• Unable to provide informed consent due to mental impairment, distress during labor or other reason
• Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IV infusion	Oxytocin	Oxytocin 10 IU will be administered IV infusion according to randomization assignment as soon as possible after delivery of the baby.
IM Injection	Oxytocin	Oxytocin 10 IU will be administered IM according to randomization assignment as soon as possible after delivery of the baby.

Primary Outcome Measures

Name	Time	Method
Mean blood loss (ml)	minimum of 1 hour after delivery of baby

Secondary Outcome Measures

Name	Time	Method
Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy	minimum of 1 hour after delivery of baby
Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml	minimum of 1 hour after delivery of baby
Time to placental delivery	minimum of 1 hour after delivery of baby
Side effects 1 hour postpartum	1 hour postpartum
Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward	arrival to labor ward
Change in hemoglobin from pre-delivery to postpartum	12-24 hours after delivery	Post-delivery hemoglobin using a Hemocue® Hemoglobin machine + cuvette will be taken at least 24 after delivery and before the woman leaves the facility. If the woman has received IV fluids, hemoglobin will be measured at least 12 hours after removal of the IV prior to discharge.

Trial Locations

Locations (3)

Hospital Gineco-Obstétrico Isidro Ayora; 🇪🇨 Quito, Ecuador

SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi; 🇹🇷 Ankara, Turkey

Huong Vuong Hospital; 🇻🇳 Ho Chi Minh City, Vietnam