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A Trial of Oral Misoprostol for Labor Augmentation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00906347
First received: May 19, 2009
Last updated: November 8, 2012
Last verified: May 2009
History of Changes
  Purpose

This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.


Condition Intervention Phase
Labor Augmentation
 Drug: Misoprostol
Drug: Oxytocin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of Oral Misoprostol for Labor Augmentation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Uterine Tachysystole [ Time Frame: Up to four hours after administration of study drug ] [ Designated as safety issue: Yes ]
    Defined as six contractions in two consecutive 10-minute periods


Secondary Outcome Measures:
  • Infant Apgar Score <4 [ Time Frame: 5 minutes after delivery ] [ Designated as safety issue: Yes ]
    Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes.

  • Umbilical Cord Artery pH <7.1 [ Time Frame: Obtained at delivery ] [ Designated as safety issue: Yes ]
  • Admission of Neonatal Intensive Care Unit [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]
  • Maternal Chorioamnionitis [ Time Frame: During labor ] [ Designated as safety issue: No ]
    Temperature 38 degrees C or higher in the absence of other sources of infection

  • Maternal Hypovolemia Requiring Blood Transfusion [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]
  • Method of Delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Time Elapsed From Start of Labor Augmentation to Delivery [ Time Frame: Initiation of augmentation until delivery ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: December 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxytocin augmentation
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
 Drug: Oxytocin
Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
Other Name: Pitocin
Active Comparator: Misoprostol augmentation
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
 Drug: Misoprostol
75 micrograms orally every 4 hours for up to 2 doses.
Other Name: Cytotec

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical decision to augment labor
  • Gestational age > than or equal to 36 weeks
  • Singleton gestation
  • Cephalic presentation
  • Reassuring fetal heart rate tracing
  • Cervical dilation between 4 and 8 cm
  • Ruptured membranes with clear amniotic fluid
  • Intrauterine pressure catheter in place
  • Less than 200 MVUs in a 10 minute period
  • 5 or fewer contractions in a 10 minute period
  • English or Spanish speaking patient

Exclusion Criteria:

  • Non-reassuring fetal heart rate tracing at time of enrollment
  • Meconium stained amniotic fluid
  • Previous uterine incision
  • Maternal fever (defined as greater than 37.9 C)
  • Known fetal anomalies
  • Placenta previa or unexplained vaginal bleeding
  • Estimated fetal weight of 4,500 grams or more
  • Abnormal maternal bony pelvis
  • Grandmultiparity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906347

Locations
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: April Bleich, MD University of Texas Southwestern Medical Center
Study Director: Kenneth Leveno, MD University of Texas Southwestern Medical Center
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00906347     History of Changes
Other Study ID Numbers: 102008-030
Study First Received: May 19, 2009
Results First Received: October 5, 2012
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Labor augmentation
Oral misoprostol

Additional relevant MeSH terms:
Oxytocin
Misoprostol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 22, 2013