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Completed

NCT Number: NCT03039036

Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction

Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However, the timing is highly variable. The purpose of this study is to determine if first time mothers undergoing induction of labor with a Foley catheter experience a decrease in their labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least 4 hours after Foley catheter removal). Other aims include the relationship between timing of amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar score <7 at 5 minutes, neonatal need for intensive care.

The investigators hypothesize that induction of labor with Foley catheters followed by early amniotomy will result in a decreased duration of labor compared to those who undergo delayed amniotomy.

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Key information

Conditions

Labor Induction

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

About this study

This randomized clinical trial of consenting nulliparous women undergoing induction of labor with a Foley catheter seeks to determine whether use of early amniotomy (defined as amniotomy within 1 hour of Foley catheter removal) improves obstetrical outcomes when compared with delayed amniotomy (defined as amniotomy at least 4 hours following Foley catheter removal).

This project will include 110 women recruited from the obstetrical service at Prentice Women's Hospital. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter. Following removal of Foley catheter, women will be assessed for safety of amniotomy and if appropriate, randomized to either early amniotomy or delayed amniotomy.

Women will be randomized with equal probability to the intervention group using block randomization stratified by use of Foley catheter alone or Foley catheter-misoprostol use.

Women in the early amniotomy group will undergo amniotomy within 1 hour of Foley catheter removal. Women in the delayed amniotomy group will undergo amniotomy at least 4 hours following Foley removal. The remainder of labor management will be at the discretion of each woman's obstetric provider.

Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to provide informed consent
  • English speaking
  • Women age 18 years old or greater
  • Nulliparous
  • Pregnant with a singleton gestation that is greater than or equal to 37 weeks
  • Undergoing induction of labor with Foley catheter

Exclusion criteria

  • Women not meeting above criteria
  • Fetus in non-cephalic position
  • Intrauterine fetal demise
  • Fetus with major anomalies
  • HIV, hepatitis B or C infection
  • Planned use of oxytocin during the Foley catheter ripening

Treatment and study plan

Amniotomy

Procedure

Artificially rupturing membranes

foley catheter

Device

Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline. It is removed when either 1. it falls out under gentile traction during labor checks or 2. it is de-inflated at 12 hours after placement. If at the time of de-inflation at 12 hours, the desired affect has not been achieved, the provider may choose to place another foley balloon or use an alternative method of induction (misoprostol). This is an eligibility criteria and only patients who are undergoing induction with a Foley Catheter will be approached for enrollment.

Misoprostol

Drug

Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg. Use of this medication will be decided by the provider.

Primary outcomes

  1. Time interval from Foley catheter removal to delivery

    Time frame: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.

    Hours

Secondary outcomes

  1. Cesarean delivery

    Time frame: At time of delivery

    binary; yes/no

  2. Chorioamnionitis

    Time frame: From time of admission to Labor and Delivery unit to delivery of neonate; up to 72 hours

    Maternal Temperature of >/= 39 degrees Celsius or >/= 38 degrees Celsius on two occasions greater than 30 minutes apart and at least one of the following: Fetal tachycardia (defined as sustained (>10 min) fetal heart rate >160), White Bood Cell Count >15, purulent fluid from cervical os, or receipt of antibiotics and diagnosis written in the chart

  3. Postpartum Fever

    Time frame: From time of delivery to time of hospital discharge; up to 6 weeks

    Temperature >/= 38 degrees celsius on 2 separate occasions greater than 6 hours apart

  4. Wound infection

    Time frame: From time of delivery to time of hospital discharge; up to 6 weeks

    Cellulitis or erythema and induration around the incision and purulent discharge from the incision site with or without fever

  5. Endometritis

    Time frame: From time of delivery to time of hospital discharge; up to 6 weeks

    fundal tenderness and fever that required treatment with antibiotics

  6. 5 minute Apgar Score less than 7 out of 10

    Time frame: 5 minutes following delivery; 5 minutes of neonatal life.

    Neonatal Apgar scores consist of measurements of neonatal skin color, respiratory rate, heart rate, muscle tone, and irritability. Each parameter is given a score of 0, 1 or 2 based on standardized parameters. It is standard to perform this on all neonates at 1 minute and 5 minutes of life. Apgar scores are performed and calculated by nursing staff or members of the pediatric team. For this outcome, we are interested in scores less than 7 out of 10 at 5 minutes of life.

  7. Neonatal intensive care unit admission

    Time frame: From time of delivery to hospital discharge; up to 6 weeks

    Admission to the neonatal intensive care unit for greater than 24 hours

  8. Length of Labor

    Time frame: Time from placement of Foley catheter to time of delivery of neonate; up to 5 days

    hours

  9. Suspected or confirmed neonatal sepsis

    Time frame: From time of delivery to hospital discharge; up to 6 weeks

    As clinical suspected by the neonatology team or with positive cultures

  10. Postpartum hemorrhage

    Time frame: From time of delivery to time of hospital discharge; up to 6 weeks

    Delivery estimated blood loss of > 500 cc for vaginal delivery or > 1000 cc for cesarean delivery

  11. Delivery time less than 24 hours

    Time frame: From time of placement of Foley catheter to time of delivery of neonate; within 24 hours.

    binary; yes/no

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

A Randomized Clinical Trial of Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2017
Registry last updated
Apr 3, 2023

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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