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Oral Misoprostol for Labor Augmentation: A Pilot Study

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.
ClinicalTrials.gov Identifier: NCT00906126
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : May 21, 2009
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Arrest of Dilation in Labor Drug: Misoprostol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. uterine hyperstimulation

Secondary Outcome Measures :
  1. adequate uterine activity
  2. need for oxytocin augmentation
  3. time from administration of study drug to delivery
  4. route of delivery and indications
  5. maternal and neonatal infectious morbidity
  6. neonatal outcomes


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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

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

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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 Posted: May 21, 2009    Key Record Dates
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:
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Dilatation, Pathologic
Pathological Conditions, Anatomical
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics