Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT

Postpartum Hemorrhage Clinical Trial

Official title:

Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790062
• Other study ID #: F070910007
• Secondary ID: 5K12HD001258-09
• Status: Completed
• Phase: Phase 4
• First received: November 12, 2008
• Last updated: December 10, 2013
• Start date: November 2008
• Est. completion date: June 2010

Study information

• Verified date: December 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a double-blind 3-arm randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not known.

Description:

Same as brief summary. Prospective interim monitoring (stopping) rules will be assessed upon recruitment of 2/3rds of the sample size of 1800. Interim review was conducted by a 3-member DSMB in January of 2010 and their recommendations were implemented.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1798
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• > 24 weeks, viable pregnancy, singleton or twins

Exclusion Criteria:

• No consent

• Contraindication to oxytocin

• Antepartum fetal demise

• Intrapartum use of concentrated oxytocin

• Planned cesarean

• DIC or coagulopathy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Uterine Atony
• Uterine Inertia

Intervention

Drug:
• Oxytocin
See arms

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tita AT, Szychowski JM, Rouse DJ, Bean CM, Chapman V, Nothern A, Figueroa D, Quinn R, Andrews WW, Hauth JC. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):293-300. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment	The primary composite is defined as the number of subjects with any treatment of uterine atony or hemorrhage.	Prior to initial discharge from hospital	No
Secondary	The Primary Outcome in a Subgroup of Women With Risk Factors for Atony or Postpartum Hemorrhage		Initial hospital discharge (2-3 days)	No
Secondary	Change in Pre- to Post-delivery Hematocrit (%)	change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)	During delivery hospitalization: Admission hematocrit - post-delivery hematocrit	No
Secondary	Each Individual Treatment or Intervention in the Primary Outcome	the number of individuals with each of the component treatments or individual outcomes in the primary composite.	prior to discharge	No
Secondary	Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)	the number of individuals with a clinically estimated postpartum blood loss of 500cc or more	Initial hospital discharge (2-3 days)	No
Secondary	Hospital Stay > 4 Days	Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge	Initial hospital discharge (2 days or more)	No
Secondary	Hypotension Warranting Pressor Agent or Fluid Bolus	number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)	Initial hospital discharge (2-3 days or more)	Yes

External Links

•   PUBMED Abstract of Results