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Completed

NCT Number: NCT01279343

Cervical Foley Plus Vaginal Misoprostol for Labor Induction

The purpose of this study is to compare the efficacy of the combination of the supracervical foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter induction to delivery time.

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Key information

Conditions

Induction of Labor

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

More than 22% of all gravid women undergo induction of labor in the United States for various indications. Although there are several techniques and methods for induction of labor, the best agent and method still remains uncertain. To date, there has been no randomized trial comparing foley bulb plus vaginal misoprostol versus vaginal misoprostol alone. The combination of a mechanical device (foley bulb) and synthetic prostaglandin may have an additive or synergistic effect, resulting in greater degree of cervical ripening and shorter induction to delivery time (IDT). The addition of a synthetic prostaglandin to the foley bulb may also overcome the frequent observation of cervical dilation to 4cm by the foley bulb without effacement.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • singleton pregnancy
  • vertex presentation
  • unfavorable cervix(Bishop's score less than or equal to 6)
  • greater than 24 weeks gestation

Exclusion criteria

  • fetal malpresentation
  • multifetal gestation
  • spontaneous labor
  • more than 5 uterine contractions in 10 minutes
  • contraindication to prostaglandins
  • non-reassuring fetal heart rate tracing
  • intrauterine growth restriction
  • anomalous fetus
  • fetal demise
  • previous cesarean delivery or other significant uterine surgery

Treatment and study plan

Foley bulb

Device

This is a randomized trial comparing foley bulb with the use of misoprostol versus use of misoprostol alone for cervical ripening and labor induction.

Other names: cytotec

Primary outcomes

  1. Time From Start of Labor Induction to Vaginal Delivery

    Time frame: 72 hours

Secondary outcomes

  1. Successful Number of Vaginal and Cesarean Deliveries

    Time frame: 72 hours

    To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries.

  2. Number of Participants Experiencing Tachysystole With Deceleration

    Time frame: 72 hours

  3. Number of Participants With Post-partum Hemorrhage

    Time frame: 96 hours

  4. Chorioamnionitis

    Time frame: 96 hours

  5. Neonatal APGAR Scores

    Time frame: 5 minutes

    APGAR scores will be recorded at 1 and 5 minutes after birth. In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score:

    Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort)

  6. NICU Admission

    Time frame: 96 hours

  7. Time to Complete Cervical Dilation

    Time frame: 72 hours

    We will record the start time of induction until the patient's cervix is 10cm dilated

  8. Delivery Within 24 Hours

    Time frame: Delivery within 24 hours of induction

  9. Admission to NICU or Special Care Nursery

    Time frame: birth to 96 hours of age

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Cervical Foley Plus Vaginal Misoprostol Versus Vaginal Misoprostol for Cervical Ripening and Labor Induction: A Randomized Trial

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 19, 2011
Registry last updated
May 3, 2019

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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