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Completed

NCT Number: NCT03725397

Inpatient Versus Outpatient Foley Cervical Ripening Study

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital, York Street Campus, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Outpatient

Behavioral

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

Inpatient

Behavioral

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

Primary outcomes

  1. Time of Foley catheter extrusion

    Time frame: within 24 hours

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

Secondary outcomes

  1. Bishop score

    Time frame: during labor

    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

  2. Total time in cervical ripening

    Time frame: from labor induction to delivery time

    Measure of total time in cervical ripening

  3. Total time slept during pre-induction

    Time frame: during labor

    Total time slept during pre-induction

  4. Total time in hospital

    Time frame: no max but an average of 3 days

    Total time in hospital

  5. Analgesia used during pre-induction

    Time frame: within 24 hours before Pitocin initiation

    Analgesia used during pre-induction

  6. Use of oxytocin

    Time frame: 3 days

    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).

  7. Fever over 38 degrees C

    Time frame: within 7 days of Foley placement

    Did the patient have a fever over 38 degrees C

  8. Neonatal Intensive Care Unit (NICU)

    Time frame: within 7 days of Foley placement

    Was the baby admitted to NICU

  9. APGAR scores

    Time frame: 1 minute of life

    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.

  10. APGAR scores

    Time frame: 5 minutes of life

    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.

  11. Hospital charges

    Time frame: within 30 days after discharge

    All patients will be charged. We are hoping to see lower charges for women in the Out Patient group.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2018
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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