Oral Misoprostol for Labor Augmentation: A Pilot Study

May 20, 2009 updated by: University of Texas Southwestern Medical Center

Oral Misoprostol for Labor Augmentation: A Dose-Finding Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Misoprostol 1
Oral misoprostol 25 micrograms every 4 hours for up to two doses.
Drug: Misoprostol
Oral misoprostol
Other Names:
  • Cytotec
Experimental: Oral Misoprostol 2
Oral misoprostol 50 micrograms every 4 hours for up to two doses.
Drug: Misoprostol
Oral misoprostol
Other Names:
  • Cytotec
Experimental: Oral Misoprostol 3
Oral misoprostol 100 micrograms every 4 hours for up to two doses.
Drug: Misoprostol
Oral misoprostol
Other Names:
  • Cytotec
Experimental: Oral Misoprostol 4
Oral Misoprostol 50 micrograms every 2 hours for up to two doses.
Drug: Misoprostol
Oral misoprostol
Other Names:
  • Cytotec
Experimental: Oral Misoprostol 5
Oral Misoprostol 75 micrograms every 4 hours for up to two doses.
Drug: Misoprostol
Oral misoprostol
Other Names:
  • Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
uterine hyperstimulation

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Kathryn S Villano, M.D., University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

May 21, 2009

Last Update Submitted That Met QC Criteria

May 20, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 122006051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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