Induction of Labor Affected Fetus / Newborn
Conditions
Keywords
Cervical Ripening
Brief summary
Induction of labor is a frequently planned obstetric procedure. Induction for women with an unfavorable cervix (bishop score \<6) increases the risk of cesarean section. This risk may be reduced by ripening or softening the cervix before the induction of labor. This protocol outlines a randomized trial of 200 women evaluating the placement and use of Cervidil to the post vaginal fornix to soften the cervix in preparation for induction. This trial is looking at inpatient vs outpatient pre-induction cervical ripening using Cervidil and the effects on (1) maternal and newborn outcomes including time of admission to delivery, (2) system healthcare cost, (3) cost to patient, and (4) patient satisfaction. The investigators hypothesize when compared to patients admitted to the hospital for cervical ripening: 1. From the time of admission, patients in the outpatient cervical ripening arm will progress to complete cervical dilation in less time. 2. The total overall cost of care for the encounter will be reduced for the group in the outpatient cervical ripening arm. 3. Patients in the outpatient cervical ripening arm will have more overall satisfaction.
Interventions
DRUGOutpatient Dinoprostone 10mg
Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.
DRUGInpatient Dinoprostone 10 mg
Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.
Sponsors
Ferring Pharmaceuticals
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
Yes
Inclusion criteria
* Accurate gestational age dating by Intermountain dating criteria placing the patient between 39 0/7 and 41 6/7 weeks gestational at time of cervical ripening * Planning to undergo cervical ripening for induction of labor * Participants must live \<20 minutes away from the enrolling facility, or must stay \< 20 minutes away. * Pregnant women between the ages of 18 and 41 at the time of enrollment. * Fetus in vertex position
Exclusion criteria
* Gestational age \< 39 weeks or \> 41 weeks and 6 days * Hypertension (chronic, transitional, gestational, preeclampsia) * Multiple gestation * Intrauterine Growth Restriction * Anticoagulant therapy or at high risk for thromboembolism * Cardiac disease other than class I per American Heart Association (AHA) * Prior incision in the contractile portion of the uterus * Placenta previa * Oligohydramnios per American College of Obstetricians and Gynecologists (ACOG) criteria: AFI \< 5 or deepest vertical pocket \<= 2 * Polyhydramnios per ACOG criteria: Amniotic Fluid Index (AFI) \>= 24 * Cervical dilation \>= 3cm * Known fetal anomaly that would require advanced neonatal care * Pitocin-induction of labor is otherwise contraindicated * Patient is receiving other uterotonics (e.g. oxytocin, Cytotec, etc.) * Fetal distress * Unexplained vaginal bleeding during the pregnancy * Sensitivity to prostaglandin * Evidence of or suspicion of marked cephalo-pelvic disproportion (per the Cervidil package insert revision 02/2016, Ferring Pharmaceuticals Inc. Parsippany, NJ)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dilation Completion Time | Time of admission to completion of dilation (up to 48 hours) | Time of admission for induction to complete dilation. |
| Total Cost of Induction Charged to Patient | Through study completion (up to 1 year) | Total hospital charges to patient, as obtained by Intermountain Healthcare billing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Delivery Rate | Through study completion (up to 1 year) | Number of patients enrolled who delivered vaginally |
| Operative Vaginal Delivery Rate | Through study completion (up to 1 year) | Number of patients enrolled who required an operative vaginal delivery |
| Cesarean Delivery Rate | Through study completion (up to 1 year) | Number of patients enrolled who had a c-section delivery |
| Patient Satisfaction: Survey | Time of delivery to discharge (up to 96 hours) | Measured by patient satisfaction/pain/anxiety survey. Questions about patient satifisfaction, pain, and anxiety will have Likert scale responses that range from 2 to 10 choices. Each question will be evaluated independently between cases and controls. |
| Start of Oxytocin Until Delivery | Time oxytocin is administered to time of delivery (up to 24 hours) | Length of time between patient receiving oxytocin and delivery |
| Time of Delivery Until Discharge | Time of delivery to discharge (up to 96 hours) | Length of time between delivery and discharge. |
| Time of Admission Until Discharge | Time of admission to labor and delivery to discharge (up to 96 hours) | Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infant 5 Minute APGAR Score | From delivery to 5 minutes following delivery | APGAR score 5 minutes after delivery. The score ranges from 0 to 10 and a score of 7 or above is considered good health. |
| Time of Admission to Postpartum | Time of admission to postpartum until discharge (up to 96 hours) | Length of stay on postpartum unit. |
| NICU Admission | Time of admission to NICU to discharge (up to 3 weeks) | Length of time spent in NICU |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Outpatient Cervical Ripening Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction. | 4 |
| Inpatient Cervical Ripening The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized. | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Inpatient Cervical Ripening | Total | Outpatient Cervical Ripening |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 8 Participants | 4 Participants |
| Age, Continuous | 30.5 Years | 27.5 Years | 24.5 Years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 4 participants | 8 participants | 4 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 1 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
Dilation Completion Time
Time of admission for induction to complete dilation.
Time frame: Time of admission to completion of dilation (up to 48 hours)
Population: Trial terminated prior to meeting sufficient sample size for analysis.
Primary
Total Cost of Induction Charged to Patient
Total hospital charges to patient, as obtained by Intermountain Healthcare billing
Time frame: Through study completion (up to 1 year)
Population: Trial terminated prior to meeting sample size for sufficient analysis.
Secondary
Cesarean Delivery Rate
Number of patients enrolled who had a c-section delivery
Time frame: Through study completion (up to 1 year)
Population: Trial terminated prior to meeting sufficient sample size for analysis.
Secondary
Operative Vaginal Delivery Rate
Number of patients enrolled who required an operative vaginal delivery
Time frame: Through study completion (up to 1 year)
Population: Trial terminated prior to meeting sufficient sample size for analysis.
Secondary
Patient Satisfaction: Survey
Measured by patient satisfaction/pain/anxiety survey. Questions about patient satifisfaction, pain, and anxiety will have Likert scale responses that range from 2 to 10 choices. Each question will be evaluated independently between cases and controls.
Time frame: Time of delivery to discharge (up to 96 hours)
Population: Trial terminated prior to meeting sufficient sample size for analysis.
Secondary
Start of Oxytocin Until Delivery
Length of time between patient receiving oxytocin and delivery
Time frame: Time oxytocin is administered to time of delivery (up to 24 hours)
Population: Trial terminated prior to meeting sufficient sample size for analysis.
Secondary
Time of Admission Until Discharge
Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge
Time frame: Time of admission to labor and delivery to discharge (up to 96 hours)
Population: Trial terminated prior to meeting sufficient sample size for analysis.
Secondary
Time of Delivery Until Discharge
Length of time between delivery and discharge.
Time frame: Time of delivery to discharge (up to 96 hours)
Population: Trial terminated prior to meeting sufficient sample size for analysis.
Secondary
Vaginal Delivery Rate
Number of patients enrolled who delivered vaginally
Time frame: Through study completion (up to 1 year)
Population: Trial terminated prior to meeting sufficient sample size for analysis.
Other Pre-specified
Infant 5 Minute APGAR Score
APGAR score 5 minutes after delivery. The score ranges from 0 to 10 and a score of 7 or above is considered good health.
Time frame: From delivery to 5 minutes following delivery
Population: Trial terminated prior to meeting sufficient sample size for analysis.
Other Pre-specified
NICU Admission
Length of time spent in NICU
Time frame: Time of admission to NICU to discharge (up to 3 weeks)
Population: Trial terminated prior to meeting sufficient sample size for analysis.
Other Pre-specified
Time of Admission to Postpartum
Length of stay on postpartum unit.
Time frame: Time of admission to postpartum until discharge (up to 96 hours)
Population: Trial terminated prior to meeting sufficient sample size for analysis.