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

Postpartum Hemorrhage Clinical Trial

Official title:

Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608958
• Other study ID #: 3000
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: March 25, 2016
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 653
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Oxytocin
10 IU oxytocin in 500 ml infusion
• Oxytocin
10 IU oxytocin IM injection

Locations

Country	Name	City	State
Ecuador	Hospital Gineco-Obstétrico Isidro Ayora	Quito
Turkey	SB Etlik Zübeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi	Ankara
Vietnam	Huong Vuong Hospital	Ho Chi Minh City

Sponsors (4)

Lead Sponsor	Collaborator
Gynuity Health Projects	Center for Research and Consultancy in Reproductive Health, Huong Vuong Hospital, MOH Etlik Zubeyde Hanim Women's Health Training and Research Hospital

Countries where clinical trial is conducted

Ecuador,  Turkey,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean blood loss (ml)		minimum of 1 hour after delivery of baby	No
Secondary	Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml		minimum of 1 hour after delivery of baby	No
Secondary	Change in hemoglobin from pre-delivery to postpartum	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.	12-24 hours after delivery	No
Secondary	Time to placental delivery		minimum of 1 hour after delivery of baby	No
Secondary	Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy		minimum of 1 hour after delivery of baby	No
Secondary	Side effects 1 hour postpartum		1 hour postpartum	No
Secondary	Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward		arrival to labor ward	No