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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014