Inpatient Versus Outpatient Foley Cervical Ripening Study

NCT03725397 | Completed DMC

• 1 other identifier: 2000022710
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Induced; Birth

Outcome Measures

Primary Outcomes (1)

• Time of Foley catheter extrusion

  Antepartum time of Foley catheter extrusion before patient being brought to labor

  within 24 hours

Secondary Outcomes (11)

• Bishop score

  during labor

• Total time in cervical ripening

  from labor induction to delivery time

• Total time slept during pre-induction

  during labor

• Total time in hospital

  no max but an average of 3 days

• Analgesia used during pre-induction

  within 24 hours before Pitocin initiation

Study Arms (2)

Outpatients with a transcervical Foley catheter

EXPERIMENTAL

Women with a transcervical Foley catheter in place that will spend the night at home.

Behavioral: Outpatient

Inpatients with a transcervical Foley catheter

ACTIVE COMPARATOR

Women to be admitted to the hospital overnight which has been a "standard of care".

Behavioral: Inpatient

Interventions

Outpatient BEHAVIORAL

The offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home.

Outpatients with a transcervical Foley catheter

Inpatient BEHAVIORAL

Women with a transcervical Foley catheter to be admitted to the hospital overnight which has been a "standard of care".

Inpatients with a transcervical Foley catheter

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women of diverse ethnic and social background who are at term and have medical indications for delivery and who are recommended to undergo cervical ripening followed by induction of labor. These will be women who are generally healthy and their pregnancy has been uncomplicated.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (2)

Yale New Haven Hospital- St. Raphael

New Haven, Connecticut, 06511, United States

Location

Yale New Haven Hospital, York Street Campus

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

• Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.

  PMID: 32852803 DERIVED

MeSH Terms

Interventions

Inosine Monophosphate

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Katherine Kohari, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: randomized double blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two cohort double blinded clinical trial

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: October 31, 2018
• Study Start: January 8, 2019
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

US (2)