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

Labor Induction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039036
• Other study ID #: STU00204292
• Status: Completed
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Induction

Intervention

Procedure:
• Amniotomy
Artificially rupturing membranes

Device:
• Foley Catheter
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.

Drug:
• Misoprostol
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.

Locations

Country	Name	City	State
United States	Prentice Women's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (11)

Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563. — View Citation

Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca. — View Citation

Garcia-Simon R, Montanes A, Clemente J, Del Pino MD, Romero MA, Fabre E, Oros D. Economic implications of labor induction. Int J Gynaecol Obstet. 2016 Apr;133(1):112-5. doi: 10.1016/j.ijgo.2015.08.022. Epub 2015 Dec 18. — View Citation

Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol. 2006 Sep;49(3):642-57. doi: 10.1097/00003081-200609000-00022. — View Citation

Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2. — View Citation

Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778. — View Citation

Levy R, Ferber A, Ben-Arie A, Paz B, Hazan Y, Blickstein I, Hagay ZJ. A randomised comparison of early versus late amniotomy following cervical ripening with a Foley catheter. BJOG. 2002 Feb;109(2):168-72. doi: 10.1111/j.1471-0528.2002.01137.x. — View Citation

Maslow AS, Sweeny AL. Elective induction of labor as a risk factor for cesarean delivery among low-risk women at term. Obstet Gynecol. 2000 Jun;95(6 Pt 1):917-22. doi: 10.1016/s0029-7844(00)00794-8. — View Citation

Mizrachi Y, Levy M, Bar J, Kovo M. Induction of labor in nulliparous women with unfavorable cervix: a comparison of Foley catheter and vaginal prostaglandin E2. Arch Gynecol Obstet. 2016 Oct;294(4):725-30. doi: 10.1007/s00404-016-4026-9. Epub 2016 Feb 2. — View Citation

Osterman MJ, Martin JA. Recent declines in induction of labor by gestational age. NCHS Data Brief. 2014 Jun;(155):1-8. — View Citation

Smyth RM, Markham C, Dowswell T. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD006167. doi: 10.1002/14651858.CD006167.pub4. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time interval from Foley catheter removal to delivery	Hours	Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
Secondary	Cesarean delivery	binary; yes/no	At time of delivery
Secondary	Chorioamnionitis	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	From time of admission to Labor and Delivery unit to delivery of neonate; up to 72 hours
Secondary	Postpartum Fever	Temperature >/= 38 degrees celsius on 2 separate occasions greater than 6 hours apart	From time of delivery to time of hospital discharge; up to 6 weeks
Secondary	Wound infection	Cellulitis or erythema and induration around the incision and purulent discharge from the incision site with or without fever	From time of delivery to time of hospital discharge; up to 6 weeks
Secondary	Endometritis	fundal tenderness and fever that required treatment with antibiotics	From time of delivery to time of hospital discharge; up to 6 weeks
Secondary	5 minute Apgar Score less than 7 out of 10	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.	5 minutes following delivery; 5 minutes of neonatal life.
Secondary	Neonatal intensive care unit admission	Admission to the neonatal intensive care unit for greater than 24 hours	From time of delivery to hospital discharge; up to 6 weeks
Secondary	Length of Labor	hours	Time from placement of Foley catheter to time of delivery of neonate; up to 5 days
Secondary	Suspected or confirmed neonatal sepsis	As clinical suspected by the neonatology team or with positive cultures	From time of delivery to hospital discharge; up to 6 weeks
Secondary	Postpartum hemorrhage	Delivery estimated blood loss of > 500 cc for vaginal delivery or > 1000 cc for cesarean delivery	From time of delivery to time of hospital discharge; up to 6 weeks
Secondary	Delivery time less than 24 hours	binary; yes/no	From time of placement of Foley catheter to time of delivery of neonate; within 24 hours.