A Study to Compare Outpatient Foley Catheter to Usual Inpatient Care for Cervical Ripening
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 18-010661
Sponsor Protocol Number: 18-010661
About this study
The purpose of this study is to compare the length of pre-delivery hospitalization in women undergoing outpatient Foley catheter versus inpatient cervical ripening for induction of labor.
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.
- 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 < 9 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.
- New diagnosis requiring immediate hospitalization for monitoring (such as preeclampsia).
- 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 major 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.
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
Mayo Clinic principal investigator
Vanessa Torbenson, M.D.
Closed for enrollment
Publications are currently not available