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Completed

NCT Number: NCT04573517

Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor

Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon.

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Key information

Conditions

Labor Induction Early Amniotomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch

Galveston, Texas, 77550, United States

About this study

This will be an unblinded randomized clinical trial. The investigators will recruit 174 pregnant women undergoing induction of labor. Recruitment will occur on the Labor and Delivery unit at the time of induction, after the decision has been made to place a Foley balloon for cervical ripening. Enrolled subjects will be randomized to early or delayed amniotomy.

Subjects randomized to early amniotomy will undergo amniotomy within 2 hours of Foley balloon removal. Subjects randomized to delayed amniotomy will undergo amniotomy at least 4 hours after Foley balloon removal.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18
  • Singleton pregnancy
  • Term gestation (37 weeks gestation)
  • Cephalic presentation
  • Undergoing labor induction with transcervical Foley balloon

Exclusion criteria

  • Previous uterine surgery
  • Prelabor rupture of membranes
  • Severe pre-eclampsia, HELLP, or eclampsia
  • HIV, HCV, or HBV
  • Heart disease
  • Fever (≥38 0C) at admission
  • Category II or III fetal heart rate tracing prior to randomization
  • Polyhydramnios
  • Fetal growth restriction <3%
  • EFW > 4200 g
  • Fetal demise or major congenital anomaly
  • Prisoners

Treatment and study plan

Amniotomy

Procedure

Artificial rupture of amniotic membranes

FOLEY BALLOON

Device

The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.

Other names: Foley catheter, Foley bulb

Primary outcomes

  1. Time to Active Phase of Labor

    Time frame: At delivery

    Total time from initiation of labor induction to reaching 6 cm cervical dilation

Secondary outcomes

  1. Time to Delivery

    Time frame: At delivery

    Total time from initiation of labor induction to delivery

  2. Vaginal Delivery Rate

    Time frame: At delivery

    Rate of vaginal delivery within 24, 36, and 48 hours

  3. Cesarean Section Rate

    Time frame: At delivery

    Rate of cesarean section and indications

  4. Maternal Infection Composite

    Time frame: From admission to discharge, up to 2 weeks

    Includes isolated maternal fever, chorioamnionitis, endometritis, wound infection

  5. Umbilical Cord Prolapse

    Time frame: At delivery

    Rates of umbilical cord prolapse

  6. Neonatal Outcome Composite

    Time frame: From admission to discharge, up to 2 weeks

    Neonatal outcome composite including NICU admission, respiratory support, hypoxic ischemic encephalopathy, seizures, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, hypotension requiring pressors, and perinatal death.

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor: a Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2020
Registry last updated
Mar 4, 2025

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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