Inpatient Versus Outpatient Foley Cervical Ripening Study

Induced; Birth Clinical Trial

Official title:

Inpatient Versus Outpatient Foley Cervical Ripening Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725397
• Other study ID #: 2000022710
• Status: Completed
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: June 27, 2022

Study information

• Verified date: February 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting

Description:

The aim of the current study is to compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting in a diverse, urban population within the United States. We hypothesize that there will be no differences in time-to-delivery, failed induction rates, cesarean section rates, or maternal/neonatal morbidity and that there will be no differences in total length of stay (LOS), hours of sleep, active labor duration, and perceived satisfaction between groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 27, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for Induction of Labor is present

• Gestational age > 37 completed weeks with absence of comorbidities with an optimal dating (ultrasonography was performed before 22 weeks gestation)

• Singleton fetus in cephalic presentation confirmed with an ultrasound at the time of presentation for induction of labor

• Cervical exam with Bishop Score <6

• Intact membranes

• Normal vital signs (blood pressure < 140/90, normal body temperature) at the time of presentation for Induction of Labor and within the last 24 hours

• Maternal age =18 years of age

Exclusion Criteria:

• Any contraindication for vaginal birth by institutional policy

• Multiple gestation

• History of cesarean delivery

• Oligohydramnios/polyhydramnios/anhydramnios (MVP <2cm)

• Rupture of membranes

• Poorly controlled diabetes (Hgb A1C>8% and/or fingerstick glucose above target >50% of the time in the past week)

• Poorly controlled chronic hypertension, gestational hypertension or preeclampsia (patient requiring IV antihypertensives within 4 hours of arrival)

• Vaginal bleeding

• Any conditions that require continuous electronic fetal monitoring either by institutional policy or provider determination (intrahepatic cholestasis of pregnancy, intrauterine growth restriction, abnormal non-stress test, others)

• Fetal anomaly with anticipated neonatal intensive care unit admission

• Fetal demise

• HIV infection, presence of genital herpetic lesion

• History of substance abuse during this pregnancy

• History of precipitous delivery (delivery <3hrs from onset of labor)

• Poor access to care (social, distance to hospital > 45 min, limited transportation)

• Poor social situation, history of domestic violence, untreated/uncontrolled psychiatric condition

• Inability to give informed consent, history of mental retardation

• Strong preference for inpatient management

• Inability to understand English or Spanish

Related Conditions & MeSH terms

• Induced; Birth

Intervention

Behavioral:
• Outpatient
The offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home.
• Inpatient
Women with a transcervical Foley catheter to be admitted to the hospital overnight which has been a "standard of care".

Locations

Country	Name	City	State
United States	Yale New Haven Hospital, York Street Campus	New Haven	Connecticut
United States	Yale New Haven Hospital- St. Raphael	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of Foley catheter extrusion	Antepartum time of Foley catheter extrusion before patient being brought to labor	within 24 hours
Secondary	Bishop score	Bishop scoring system used to consider having cervical ripening.Women with favorable cervices (BS 8 or more) are considered to have a cervix ripe and ready to proceed to induction. BS <6 are considered unripe, and therefore may benefit from additional ripening modalities	during labor
Secondary	Total time in cervical ripening	Measure of total time in cervical ripening	from labor induction to delivery time
Secondary	Total time slept during pre-induction	Total time slept during pre-induction	during labor
Secondary	Total time in hospital	Total time in hospital	no max but an average of 3 days
Secondary	Analgesia used during pre-induction	Analgesia used during pre-induction	within 24 hours before Pitocin initiation
Secondary	Use of oxytocin	Pitocin is given as a continuous infusion and the dose is titrated according to the contraction pattern (goal max contractions but not hyperstimulation). We will calculate the total time of Pitocin infusion as well as total dose (rate of infusion x time).	3 days
Secondary	Fever over 38 degrees C	Did the patient have a fever over 38 degrees C	within 7 days of Foley placement
Secondary	Neonatal Intensive Care Unit (NICU)	Was the baby admitted to NICU	within 7 days of Foley placement
Secondary	APGAR scores	Apgar score is a universal (international) scoring system. The 1-minute score determines how well the baby tolerated the birthing process. The 5-minute score tells the health care provider how well the baby is doing outside the mother's womb.	1 minute of life
Secondary	APGAR scores	Apgar score is a universal (international) scoring system. The 1-minute score determines how well the baby tolerated the birthing process. The 5-minute score tells the health care provider how well the baby is doing outside the mother's womb.	5 minutes of life
Secondary	Hospital charges	All patients will be charged. We are hoping to see lower charges for women in the Out Patient group.	within 30 days after discharge