Trial Outcomes & Findings for Prehospital Cervical Ripening Before Induction and the Maternal Experience (NCT NCT01641601)
NCT ID: NCT01641601
Last Updated: 2020-08-05
Results Overview
Time from admission to the hospital until delivery
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
From admission to delivery, expected average of 48 hours
Results posted on
2020-08-05
Participant Flow
Participant milestones
| Measure |
Usual Management
Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis.
|
Outpatient Transcervical Foley Balloon
Patients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols.
Outpatient transcervical Foley balloon: A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Usual Management
Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis.
|
Outpatient Transcervical Foley Balloon
Patients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols.
Outpatient transcervical Foley balloon: A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction.
|
|---|---|---|
|
Overall Study
Study discontinued.
|
3
|
5
|
Baseline Characteristics
Prehospital Cervical Ripening Before Induction and the Maternal Experience
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: From admission to delivery, expected average of 48 hoursPopulation: Study terminated prior to data collection.
Time from admission to the hospital until delivery
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 48 hours after deliveryPopulation: Study terminated prior to data collection.
Maternal satisfaction with the period leading up to admission and the hospital stay, measured by interview.
Outcome measures
Outcome data not reported
Adverse Events
Usual Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Outpatient Transcervical Foley Balloon
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place