Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction

Summary

Induction of labor, or causing labor to start before it otherwise starts spontaneously, is sometimes necessary as pregnancy progresses to ensure the safety of both mother and infant. Labor induction often begins with cervical ripening, in which various methods are used to prepare the cervix for contractions and labor. Cervical ripening is beneficial and decreases the need for cesarean section; however, it can be a lengthy process. By tradition, pregnant women are admitted to the hospital at the start of this process and remain inpatient until after the baby is born.

There is increasing interest in allowing the mother to return to her own home during the very first part of this process. She may be more satisfied in a more comfortable environment with her family. Growing scientific evidence supports use of the Foley catheter as an approach to outpatient cervical ripening. The Foley catheter is a safe, effective method that is already used often in the inpatient setting. It does not cause increased health risks for either mother or baby. Previous research studies have shown that it is just as safe and effective when women return to their own homes with a Foley catheter and that women spend less time in the hospital before delivery. More information is needed before this becomes a standard of care. This research study will allow pregnant women to return home for the first night of their labor induction with a Foley catheter in place. In the morning they will return to the hospital and stay until after delivery. They will be compared to a group of women who remain in the hospital for their entire labor induction. The benefits to going home during labor induction may include increasing maternal satisfaction and optimizing the use of resources in the hospital.

Conditions

• Pregnancy

Interventions

DEVICE

Foley catheter

The Foley catheter is a device used to achieve cervical ripening at the start of labor induction. It is a single balloon catheter placed transcervically by a provider, either digitally or using a speculum for visualization. The balloon is placed above the internal os but below the fetal head, amniotic membranes, and placenta and is inflated. In this study, it will be inflated with 60 cc of normal saline and taped to the patient's thigh for traction. Over several hours, the balloon gradually dilates the cervix. The catheter is typically expulsed when the cervix is 3-4 centimeters.

DRUG

Misoprostol

Misoprostol is a prostaglandin E1 analogue that is used for cervical ripening during labor induction. A 25 microgram tablet is placed in the vagina by a provider. A new 25 mcg tablet can be used vaginally every 4 hours for up to 6 total doses.

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Vanessa E Torbenson, MD · Mayo Clinic

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2017-06-08

Completion

2017-06-08

Countries

• United States

Study Locations