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

NCT00790062 | Completed Phase 4 Results DMC

• 2 other identifiers: F0709100075K12HD001258-09
• Study Type: interventional
• Target: 1,798
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Atony; Postpartum Hemorrhage

Keywords

Uterine atony; Postpartum hemorrhage; clinical trial; Prophylactic oxytocin

Outcome Measures

Primary Outcomes (3)

• Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment

  the number of subjects with any treatment of uterineatony or hemorrhage.

  baseline to discharge (2 - 3 days)

• Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage

  In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus.

  Initial hospital discharge (2-3 days)

• Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors

  The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia.

  baseline to discharge (2-3 days)

Secondary Outcomes (5)

• Change in Pre- to Post-delivery Hematocrit (%)

  During delivery hospitalization: Admission hematocrit - post-delivery hematocrit

• Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome

  prior to discharge

• Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)

  Initial hospital discharge (2-3 days)

• Number of Subjects With Hospital Stays Greater Than 4 Days

  Initial hospital discharge (2 days or more)

• Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus

  Initial hospital discharge (2-3 days or more)

Study Arms (3)

Oxytocin 10 units/500cc

ACTIVE COMPARATOR

1 dose only for prophylaxis given over 1 hour

Drug: Oxytocin

Oxytocin 40 units/500cc

EXPERIMENTAL

One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.

Drug: Oxytocin

Oxytocin 80U/500cc

EXPERIMENTAL

1 dose only given over 1 hour

Drug: Oxytocin

Interventions

Oxytocin DRUG

See arms

Also known as: Pitocin

Oxytocin 10 units/500cc; Oxytocin 40 units/500cc; Oxytocin 80U/500cc

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 24 weeks, viable pregnancy, singleton or twins

You may not qualify if:

• No consent
• Contraindication to oxytocin
• Antepartum fetal demise
• Intrapartum use of concentrated oxytocin
• Planned cesarean
• DIC or coagulopathy

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related 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: 10.1097/AOG.0b013e318242da74.

  PMID: 22227638 RESULT

Related Links

• PUBMED Abstract of Results

MeSH Terms

Conditions

Uterine Inertia; Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Dystocia; 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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Alan T. N. Tita, MD
• Organization: University of Alabama at Birmingham

atit@uab.edu

(205) 934-9616

Study Officials

• Alan T Tita, MD, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: GT60

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 13, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 8, 2016
• Results First Posted: January 30, 2014

Record last verified: 2016-03

Locations

US (1)