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Oral Misoprostol for Labor Augmentation: A Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906126
First Posted: May 21, 2009
Last Update Posted: May 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Texas Southwestern Medical Center
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Misoprostol for Labor Augmentation: A Dose-Finding Pilot Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • uterine hyperstimulation

Secondary Outcome Measures:
  • adequate uterine activity
  • need for oxytocin augmentation
  • time from administration of study drug to delivery
  • route of delivery and indications
  • maternal and neonatal infectious morbidity
  • neonatal outcomes

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kathryn Villano, M.D., University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00906126     History of Changes
Other Study ID Numbers: 122006051
First Submitted: May 19, 2009
First Posted: May 21, 2009
Last Update Posted: May 21, 2009
Last Verified: May 2009

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
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics