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To compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatients with a transcervical Foley catheter | Experimental | Women with a transcervical Foley catheter in place that will spend the night at home. |
|
| Inpatients with a transcervical Foley catheter | Active Comparator | Women to be admitted to the hospital overnight which has been a "standard of care". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient | Behavioral | The offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time of Foley catheter extrusion | Antepartum time of Foley catheter extrusion before patient being brought to labor | within 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Total time in cervical ripening |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Kohari, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital- St. Raphael | New Haven | Connecticut | 06511 | United States | ||
| Yale New Haven Hospital, York Street Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32852803 | Derived | 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. |
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| ID | Term |
|---|---|
| D007291 | Inosine Monophosphate |
| ID | Term |
|---|---|
| D007292 | Inosine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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two cohort double blinded clinical trial
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randomized double blinded
| Inpatient | Behavioral | Women with a transcervical Foley catheter to be admitted to the hospital overnight which has been a "standard of care". |
|
Measure of total time in cervical ripening |
| from labor induction to delivery time |
| Total time slept during pre-induction | Total time slept during pre-induction | during labor |
| Total time in hospital | Total time in hospital | no max but an average of 3 days |
| Analgesia used during pre-induction | Analgesia used during pre-induction | within 24 hours before Pitocin initiation |
| 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 |
| Fever over 38 degrees C | Did the patient have a fever over 38 degrees C | within 7 days of Foley placement |
| Neonatal Intensive Care Unit (NICU) | Was the baby admitted to NICU | within 7 days of Foley placement |
| 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 |
| 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 |
| 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 |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |