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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


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
See also
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Completed NCT05429580 - Prophylactic Tranexamic Acid Use After Vaginal Delivery N/A
Terminated NCT03064152 - Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery N/A
Recruiting NCT05382403 - Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage N/A
Completed NCT02910310 - Introduction of UBT for PPH Management in Three Countries N/A
Completed NCT02805426 - Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage Phase 4
Not yet recruiting NCT02853552 - Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding Phase 4

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