Induced; Birth
Conditions
Brief summary
To compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting
Detailed 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.
Interventions
BEHAVIORALOutpatient
The offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home.
BEHAVIORALInpatient
Women with a transcervical Foley catheter to be admitted to the hospital overnight which has been a standard of care.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
randomized double blinded
Intervention model description
two cohort double blinded clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of Foley catheter extrusion | within 24 hours | Antepartum time of Foley catheter extrusion before patient being brought to labor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total time in cervical ripening | from labor induction to delivery time | Measure of total time in cervical ripening |
| Total time slept during pre-induction | during labor | Total time slept during pre-induction |
| Total time in hospital | no max but an average of 3 days | Total time in hospital |
| Analgesia used during pre-induction | within 24 hours before Pitocin initiation | Analgesia used during pre-induction |
| Bishop score | 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 |
| Fever over 38 degrees C | within 7 days of Foley placement | Did the patient have a fever over 38 degrees C |
| Neonatal Intensive Care Unit (NICU) | within 7 days of Foley placement | Was the baby admitted to NICU |
| APGAR scores | 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. |
| Hospital charges | within 30 days after discharge | All patients will be charged. We are hoping to see lower charges for women in the Out Patient group. |
| Use of oxytocin | 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). |
Countries
United States
Outcome results
None listed