Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Pregnant women at ≥37 weeks gestation by reliable dating criteria as determined by the American College of Obstetricians and Gynecologists (i.e. gestational age supported by one of the following: ultrasound prior to 20 weeks of gestation, fetal heart tones auscultated by Doppler for 30+ weeks, or documented serum or urine pregnancy test 36+ weeks ago)
Scheduled induction of labor with indication and timing supported by the Family Birth Center induction of labor guideline entitled "Induction of labor: Indications and Timing"
Singleton gestation
Cephalic presentation
Amniotic fluid index greater than or equal to 5 centimeters
Formal prenatal ultrasound documenting the absence of placenta previa
Bishop score <6 and cervical dilation <3cm
The woman is able to give appropriate consent and has undergone an informed consent process.
Maternal age ≥ 18 years old at the time of consent.

Exclusion Criteria

New diagnosis requiring immediate hospitalization for monitoring (such as new onset hypertensive disease of pregnancy)
Vaginal bleeding
Active labor
Premature rupture of membranes as determined by positive ferning and as supported by pooling of fluid in the vaginal vault.
Uterine tachysystole (>5 contractions in 10 minutes)
Nonreassuring fetal heart tracing before or after Foley placement
Chorioamnionitis or maternal fever
Intrauterine fetal demise
Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine surgery)
Abnormal placentation including a low lying placenta
Prior cesarean delivery
Intrauterine growth restriction (growth <10th percentile by formal ultrasound)
Known fetal anomaly
Human immunodeficiency virus, Hepatitis C, or active herpes infection
Maternal cardiopulmonary disease requiring cardiac monitoring during labor
Pregestational diabetes
Rh isoimmunization
Non-English speaking
Distance from the hospital over 60 minutes by car, unreliable communication via telephone, or unreliable transportation

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Vanessa Torbenson, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Vanessa Torbenson, M.D.

Closed for enrollment

More information

Publications

Induction of labour (IOL) is one of the commonest obstetric interventions, with significant impact on both the individual woman and health service delivery. Outpatient IOL is an attractive option to reduce these impacts. To date there is little data comparing outpatient and inpatient IOL methods, and potential safety concerns (hyperstimulation) if prostaglandins, the standard inpatient IOL medications, are used in the outpatient setting. The purpose of this study was to assess feasibility, clinical effectiveness and patient acceptability of outpatient Foley catheter (OPC) vs. inpatient vaginal PGE2 (IP) for induction of labour (IOL) at term. Read More on PubMed
Mechanical methods were the first methods developed to ripen the cervix and induce labour. During recent decades they have been substituted by pharmacological methods. Potential advantages of mechanical methods, compared with pharmacological methods, may include simplicity of preservation, lower cost and reduction of the side effects. Read More on PubMed
To compare use of the Foley catheter for preinduction cervical ripening in an inpatient versus outpatient setting. Read More on PubMed

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