Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction

• Status: Terminated
• Trial end date: 2017-06-08
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Misoprostol

Criteria

Inclusion Criteria

1. 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)

2. 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"

3. Singleton gestation

4. Cephalic presentation

5. Amniotic fluid index greater than or equal to 5 centimeters

6. Formal prenatal ultrasound documenting the absence of placenta previa

7. Bishop score <6 and cervical dilation <3cm

8. The woman is able to give appropriate consent and has undergone an informed consent process.

9. Maternal age ≥ 18 years old at the time of consent.

Exclusion Criteria

1. New diagnosis requiring immediate hospitalization for monitoring (such as new onset hypertensive disease of pregnancy)

2. Vaginal bleeding

3. Active labor

4. Premature rupture of membranes as determined by positive ferning and as supported by pooling of fluid in the vaginal vault.

5. Uterine tachysystole (>5 contractions in 10 minutes)

6. Nonreassuring fetal heart tracing before or after Foley placement

7. Chorioamnionitis or maternal fever

8. Intrauterine fetal demise

9. Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine surgery)

10. Abnormal placentation including a low lying placenta

11. Prior cesarean delivery

12. Intrauterine growth restriction (growth <10th percentile by formal ultrasound)

13. Known fetal anomaly

14. Human immunodeficiency virus, Hepatitis C, or active herpes infection

15. Maternal cardiopulmonary disease requiring cardiac monitoring during labor

16. Pregestational diabetes

17. Rh isoimmunization

18. Non-English speaking

19. Distance from the hospital over 60 minutes by car, unreliable communication via telephone, or unreliable transportation