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OpenTrials
Completed

NCT Number: NCT00906126

Oral Misoprostol for Labor Augmentation: A 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.

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Key information

Conditions

Arrest of Dilation in Labor

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

Oral misoprostol

Other names: Cytotec

Primary outcomes

  1. uterine hyperstimulation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
May 21, 2009
Registry last updated
May 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.