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Oral Misoprostol for Labor Augmentation: A Pilot Study

This study has been completed.
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00906126
First received: May 19, 2009
Last updated: May 20, 2009
Last verified: May 2009
History of Changes
  Purpose

A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment labor in nulliparous women diagnosed with arrest of dilation.


Condition Intervention Phase
Arrest of Dilation in Labor
 Drug: Misoprostol
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Misoprostol for Labor Augmentation: A Dose-Finding Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest
Drug Information available for: Misoprostol
U.S. FDA Resources

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

Primary Outcome Measures:
  • uterine hyperstimulation [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • adequate uterine activity [ Designated as safety issue: No ]
  • need for oxytocin augmentation [ Designated as safety issue: No ]
  • time from administration of study drug to delivery [ Designated as safety issue: No ]
  • route of delivery and indications [ Designated as safety issue: No ]
  • maternal and neonatal infectious morbidity [ Designated as safety issue: Yes ]
  • neonatal outcomes [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: April 2007
Study Completion Date: May 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Misoprostol 1
Oral misoprostol 25 micrograms every 4 hours for up to two doses.
 Drug: Misoprostol
Oral misoprostol
Other Name: Cytotec
Experimental: Oral Misoprostol 2
Oral misoprostol 50 micrograms every 4 hours for up to two doses.
 Drug: Misoprostol
Oral misoprostol
Other Name: Cytotec
Experimental: Oral Misoprostol 3
Oral misoprostol 100 micrograms every 4 hours for up to two doses.
 Drug: Misoprostol
Oral misoprostol
Other Name: Cytotec
Experimental: Oral Misoprostol 4
Oral Misoprostol 50 micrograms every 2 hours for up to two doses.
 Drug: Misoprostol
Oral misoprostol
Other Name: Cytotec
Experimental: Oral Misoprostol 5
Oral Misoprostol 75 micrograms every 4 hours for up to two doses.
 Drug: Misoprostol
Oral misoprostol
Other Name: Cytotec

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • nulliparous
  • gestational age of at least 36 weeks
  • singleton gestation
  • cephalic presentation
  • reassuring fetal heart rate
  • 4 cm or greater cervical dilation
  • ruptured membranes with clear amnionic fluid
  • intrauterine pressure catheter in place
  • less than 200 MVU's

Exclusion Criteria:

  • non-reassuring fetal heart rate
  • meconium-stained amnionic fluid
  • previous uterine incision
  • maternal fever
  • pregnancy-induced hypertension or other pregnancy-related complications
  • known fetal anomalies
  • placenta previa or unexplained vaginal bleeding
  • estimated fetal weight of 4,500 grams or greater
  • evidence of cephalopelvic disproportion
  • any moderate or severe preexisting disease
  • contraindication to the use of prostaglandins
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906126

Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Kathryn S Villano, M.D. University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Kathryn Villano, M.D., University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00906126     History of Changes
Other Study ID Numbers: 122006051
Study First Received: May 19, 2009
Last Updated: May 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
oral misoprostol
labor augmentation
arrest of dilation
nulliparous

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

ClinicalTrials.gov processed this record on June 17, 2013