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Completed

NCT Number: NCT00906347

A Trial of Oral Misoprostol for Labor Augmentation

This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.

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Key information

Conditions

Labor Augmentation

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Clinical decision to augment labor
  • Gestational age > than or equal to 36 weeks
  • Singleton gestation
  • Cephalic presentation
  • Reassuring fetal heart rate tracing
  • Cervical dilation between 4 and 8 cm
  • Ruptured membranes with clear amniotic fluid
  • Intrauterine pressure catheter in place
  • Less than 200 MVUs in a 10 minute period
  • 5 or fewer contractions in a 10 minute period
  • English or Spanish speaking patient

Exclusion criteria

  • Non-reassuring fetal heart rate tracing at time of enrollment
  • Meconium stained amniotic fluid
  • Previous uterine incision
  • Maternal fever (defined as greater than 37.9 C)
  • Known fetal anomalies
  • Placenta previa or unexplained vaginal bleeding
  • Estimated fetal weight of 4,500 grams or more
  • Abnormal maternal bony pelvis
  • Grandmultiparity

Treatment and study plan

Misoprostol

Drug

75 micrograms orally every 4 hours for up to 2 doses.

Other names: Cytotec

Oxytocin

Drug

Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital

Other names: Pitocin

Primary outcomes

  1. Uterine Tachysystole

    Time frame: Up to four hours after administration of study drug

    Defined as six contractions in two consecutive 10-minute periods

Secondary outcomes

  1. Infant Apgar Score <4

    Time frame: 5 minutes after delivery

    Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes.

  2. Umbilical Cord Artery pH <7.1

    Time frame: Obtained at delivery

  3. Admission of Neonatal Intensive Care Unit

    Time frame: Until hospital discharge

  4. Maternal Chorioamnionitis

    Time frame: During labor

    Temperature 38 degrees C or higher in the absence of other sources of infection

  5. Maternal Hypovolemia Requiring Blood Transfusion

    Time frame: Until hospital discharge

  6. Method of Delivery

    Time frame: At delivery

  7. Time Elapsed From Start of Labor Augmentation to Delivery

    Time frame: Initiation of augmentation until delivery

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

A Randomized, Controlled Trial of Oral Misoprostol for Labor Augmentation

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 21, 2009
Registry last updated
Nov 15, 2012

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.

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