Trial Outcomes & Findings for A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening (NCT NCT03806231)

Results Overview

Time of admission for induction to complete dilation.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

8 participants

Primary outcome timeframe

Time of admission to completion of dilation (up to 48 hours)

Results posted on

2021-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	4	4
Overall Study COMPLETED	2	4
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Outpatient Cervical Ripening n=4 Participants 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.	Inpatient Cervical Ripening n=4 Participants 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.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	4 Participants n=4 Participants	8 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Age, Continuous	24.5 Years n=4 Participants	30.5 Years n=4 Participants	27.5 Years n=8 Participants
Sex: Female, Male Female	4 Participants n=4 Participants	4 Participants n=4 Participants	8 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=4 Participants	4 participants n=4 Participants	8 participants n=8 Participants

PRIMARY outcome

Timeframe: Time of admission to completion of dilation (up to 48 hours)

Population: Trial terminated prior to meeting sufficient sample size for analysis.

Time of admission for induction to complete dilation.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Through study completion (up to 1 year)

Population: Trial terminated prior to meeting sample size for sufficient analysis.

Total hospital charges to patient, as obtained by Intermountain Healthcare billing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of delivery to discharge (up to 96 hours)

Population: Trial terminated prior to meeting sufficient sample size for analysis.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion (up to 1 year)

Population: Trial terminated prior to meeting sufficient sample size for analysis.

Number of patients enrolled who delivered vaginally

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion (up to 1 year)

Population: Trial terminated prior to meeting sufficient sample size for analysis.

Number of patients enrolled who required an operative vaginal delivery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion (up to 1 year)

Population: Trial terminated prior to meeting sufficient sample size for analysis.

Number of patients enrolled who had a c-section delivery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time oxytocin is administered to time of delivery (up to 24 hours)

Population: Trial terminated prior to meeting sufficient sample size for analysis.

Length of time between patient receiving oxytocin and delivery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of delivery to discharge (up to 96 hours)

Population: Trial terminated prior to meeting sufficient sample size for analysis.

Length of time between delivery and discharge.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of admission to labor and delivery to discharge (up to 96 hours)

Population: Trial terminated prior to meeting sufficient sample size for analysis.

Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From delivery to 5 minutes following delivery

Population: Trial terminated prior to meeting sufficient sample size for analysis.

APGAR score 5 minutes after delivery. The score ranges from 0 to 10 and a score of 7 or above is considered good health.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Time of admission to postpartum until discharge (up to 96 hours)

Population: Trial terminated prior to meeting sufficient sample size for analysis.

Length of stay on postpartum unit.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Time of admission to NICU to discharge (up to 3 weeks)

Population: Trial terminated prior to meeting sufficient sample size for analysis.

Length of time spent in NICU

Outcome measures

Outcome data not reported

Adverse Events

Outpatient Cervical Ripening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inpatient Cervical Ripening

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Outpatient Cervical Ripening n=4 participants at risk 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.	Inpatient Cervical Ripening n=4 participants at risk 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.
Pregnancy, puerperium and perinatal conditions Non-Serious Adverse Event	0.00% 0/4 • Enrollment period - Approximately 5 months	25.0% 1/4 • Number of events 1 • Enrollment period - Approximately 5 months

Additional Information

Molly Adams, Clinical Research Project Coordinator

Intermountain Healthcare

Phone: (801)507-7030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place