Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women

Pregnancy Related Clinical Trial

— OFFSITE II  

Official title:

Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women: A Randomized-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03472937
• Other study ID #: F9999999
• Status: Completed
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: December 13, 2019

Study information

• Verified date: February 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. The objective of the study is to determine if outpatient compared to inpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing induction shortens the time spent in labor and delivery (from the time of admission to the time of delivery).

Description:

Approximately 20-25% of pregnant women undergo an induction of labor, and a large percentage of these women require cervical ripening in order to "ready" the cervix for induction. In the setting of an unfavorable cervix, induction of labor with oxytocin alone can be associated with longer times to delivery, uterine tachysystole (uterine contractions that are too frequent), and increased rates of cesarean delivery.

Outpatient cervical ripening is an attractive option for both women and their physicians, as this allows for the potential to spend less time in the hospital and more time in the comforts of the patient's own home.

The investigators will conduct a randomized controlled trial comparing outpatient to inpatient cervical ripening using a transcervical Foley catheter. Women will be randomized to undergo inpatient or outpatient transcervical Foley catheter cervical ripening beyond their 39th week of gestation. Women and their infants will be followed until the time of their discharge from the hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 13, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18

• Nulliparous

• Singleton gestation

• Gestational age between 39+0 and 42+0 weeks

• Vertex presentation

• Modified Bishop score <5 and cervical dilation = 2 cm

• No prior cesarean or prior uterine surgery

• Resides within 30 minutes of UAB Hospital

• Access to a telephone

• Reliable transportation

Exclusion Criteria:

• Unsuitable for outpatient cervical ripening (e.g., IUGR, oligohydramnios, polyhydramnios, gestational hypertension or preeclampsia, complex maternal disease, provider discretion). Patients with well controlled Class A or B DM or chronic hypertension will be eligible.

• Latex allergy

• Contraindication to induction of labor

• Evidence of labor

• Fetal demise

• Fetal anomaly

• Inability to give consent (e.g., inability to read or write)

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Procedure:
• Transcervical Foley catheter placement for cervical ripening
Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (14)

ACOG Committee on Practice Bulletins -- Obstetrics. ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-97. doi: 10.1097/AOG.0b013e3181b48ef5. Review. — View Citation

Amorosa JM, Stone JL. Outpatient cervical ripening. Semin Perinatol. 2015 Oct;39(6):488-94. doi: 10.1053/j.semperi.2015.07.014. Epub 2015 Sep 11. Review. — View Citation

Biem SR, Turnell RW, Olatunbosun O, Tauh M, Biem HJ. A randomized controlled trial of outpatient versus inpatient labour induction with vaginal controlled-release prostaglandin-E2: effectiveness and satisfaction. J Obstet Gynaecol Can. 2003 Jan;25(1):23-31. — View Citation

Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007701. doi: 10.1002/14651858.CD007701.pub2. Review. Update in: Cochrane Database Syst Rev. 2017 Sep 13;9:CD007701. — View Citation

Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25. — 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. Review. — View Citation

Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007372. doi: 10.1002/14651858.CD007372.pub3. Review. — View Citation

McKenna DS, Costa SW, Samuels P. Prostaglandin E2 cervical ripening without subsequent induction of labor. Obstet Gynecol. 1999 Jul;94(1):11-4. — View Citation

O'Brien JM, Mercer BM, Cleary NT, Sibai BM. Efficacy of outpatient induction with low-dose intravaginal prostaglandin E2: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 1995 Dec;173(6):1855-9. — View Citation

Rayburn W, Gosen R, Ramadei C, Woods R, Scott J Jr. Outpatient cervical ripening with prostaglandin E2 gel in uncomplicated postdate pregnancies. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1417-23. — View Citation

Sawai SK, O'Brien WF, Mastrogiannis DS, Krammer J, Mastry MG, Porter GW. Patient-administered outpatient intravaginal prostaglandin E2 suppositories in post-date pregnancies: a double-blind, randomized, placebo-controlled study. Obstet Gynecol. 1994 Nov;84(5):807-10. — View Citation

Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17. — View Citation

Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. — View Citation

Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E2 (OPRA study). BJOG. 2015 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total time from admission to delivery		From baseline to the time of delivery (baseline is from admission)
Secondary	Modified Bishop score on admission		At baseline
Secondary	Evaluation of patient satisfaction with care	Assessed through survey adapted from "Six Simple Questions Survey," which has been published by Harvey et al (Harvey et al. Evaluation of satisfaction with midwifery care. Midwifery. 2002 Dec; 18(4):260-7.) This survey has 6 questions to assess perceptions of satisfaction with care. The questions include questions such as, "I had appropriate and adequate control over my care," "The person(s) responsible for my care are/were caring and compassionate," and "Problems that have arisen up to now have not been dealt with effectively." The scare ranges from 1-7, with 1 representing Strongly Disagree and 7 representing Strongly Agree.	Within 2-4 days after delivery
Secondary	Evaluation of patient experience on labor and delivery	Assessed through survey adapted from "Labor and Delivery Index (LADY-X" Survey, which has been published by Gartner et al (Gartner et al. Calculating Preference Weights for the Labor and Delivery Index: A Discrete Choice Experiment on Women's Birth Experiences. Value Health. 2015 Sep; 18(6):856-864.) This survey has 7 questions to assess experiences during labor and birth. Each question then has 3 answer choices that describe how good/poor the experience was. An example of a question is, "Taking your wishes seriously during childbirth." The answers then include "very seriously, sufficiently seriously, or insufficiently seriously."	Within 2-4 days after delivery
Secondary	Evaluation of pain experienced during childbirth	Assessed through survey that contains 4 questions. The first 3 questions assess pain (worst pain during labor, overall pain during labor, and worse pain during placement of the Foley balloon). The 4th question asks how likely a patient is to recommend her method of induction to a friend/family member. The scale ranges from 0-100, with 0 representing no pain or very unlikely and 100 representing pain as bad as it could possibly be or very likely. The patient is instructed to place a hash mark over the line.	From placement of Foley bulb to delivery
Secondary	Vaginal bleeding greater than bloody show	Vaginal bleeding that is like a period or more	From placement of Foley bulb to delivery
Secondary	Total hospital duration		From hospital admission to hospital discharge (generally less than one week)
Secondary	Rates of acetaminophen use		From placement of Foley bulb to 24 hours
Secondary	Rates of calls to the obstetrical triage unit		From placement of Foley bulb to 24 hours
Secondary	Early admission or early visit to the obstetrical triage unit prior to scheduled induction of labor time		From placement of Foley bulb to 24 hours
Secondary	Rates of spontaneous rupture of membranes between Foley bulb placement and admission		From placement of Foley bulb to 24 hours
Secondary	Non-reassuring fetal heart rate tracings 30-minutes after Foley bulb placement		From placement of Foley bulb to 30 minutes
Secondary	Total duration of time of neuraxial anesthesia use		From baseline to delivery
Secondary	Total time of oxytocin infusion		From baseline to delivery
Secondary	Maximum oxytocin rate		From baseline to delivery
Secondary	Highest maternal intrapartum temperature		From baseline to delivery
Secondary	Rates of chorioamnionitis		From baseline to delivery
Secondary	Rates of endometritis		From delivery until 30 days post-discharge
Secondary	Mode of delivery	Rates of vaginal delivery, cesarean delivery, and operative vaginal delivery (vacuum or forceps)	From baseline to delivery
Secondary	Postpartum hemorrhage		At delivery
Secondary	Rates of hospital readmission within 30 days		From hospital discharge until 30 days post-discharge
Secondary	Rates of 5-minute Apgar score <7		From time of delivery up to 5 minutes post-delivery
Secondary	Rates of umbilical cord artery pH <7.1		From time of delivery up to 5 minutes post-delivery
Secondary	Rates of umbilical cord artery base deficit <-12		From time of delivery up to 5 minutes post-delivery
Secondary	Rates of neonatal intensive care unit admissions		After delivery and before neonatal discharge (generally less than one week)

External Links

•   WHO Recommendations for Induction of Labour