Outpatient
BehavioralThe offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home.
NCT Number: NCT03725397
To compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting
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Notify Me18 year and older
Female
Interventional
Not applicable
Yale New Haven Hospital, York Street Campus, New Haven, Connecticut, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home.
Women with a transcervical Foley catheter to be admitted to the hospital overnight which has been a "standard of care".
Time frame: within 24 hours
Antepartum time of Foley catheter extrusion before patient being brought to labor
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
Time frame: from labor induction to delivery time
Measure of total time in cervical ripening
Time frame: during labor
Total time slept during pre-induction
Time frame: no max but an average of 3 days
Total time in hospital
Time frame: within 24 hours before Pitocin initiation
Analgesia used during pre-induction
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).
Time frame: within 7 days of Foley placement
Did the patient have a fever over 38 degrees C
Time frame: within 7 days of Foley placement
Was the baby admitted to NICU
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.
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.
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.
Yale University
Other
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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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