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

University of Alabama at Birmingham126 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Pregnancy Related

Interventions

Transcervical Foley catheter placement for cervical ripeningPROCEDURE

Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Total time from admission to delivery

Time frame: From baseline to the time of delivery (baseline is from admission)

Secondary Outcomes

Modified Bishop score on admission

Time frame: At baseline

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.

Time frame: Within 2-4 days after delivery

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."

Time frame: Within 2-4 days after delivery

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.

Data from ClinicalTrials.gov

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