Trial Outcomes & Findings for Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin (NCT NCT03138252)
NCT ID: NCT03138252
Last Updated: 2022-05-04
Results Overview
Time from placement of cervical ripening balloon to delivery
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
180 participants
Primary outcome timeframe
Time to delivery
Results posted on
2022-05-04
Participant Flow
Participant milestones
| Measure |
Cervical Ripening Balloon Alone
Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Oxytocin
|
Cervical Ripening Balloon + Oxytocin
Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Oxytocin
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
COMPLETED
|
90
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin
Baseline characteristics by cohort
| Measure |
Cervical Ripening Balloon Alone
n=90 Participants
Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Oxytocin
|
Cervical Ripening Balloon + Oxytocin
n=90 Participants
Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Oxytocin
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
77 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=99 Participants
|
90 participants
n=107 Participants
|
180 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Time to deliveryTime from placement of cervical ripening balloon to delivery
Outcome measures
| Measure |
Cervical Ripening Balloon Alone
n=90 Participants
Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Oxytocin
|
Cervical Ripening Balloon + Oxytocin
n=90 Participants
Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Oxytocin
|
|---|---|---|
|
Time From Cervical Ripening to Delivery
|
16.88 hours
Interval 12.7 to 24.4
|
13.13 hours
Interval 10.8 to 17.7
|
Adverse Events
Cervical Ripening Balloon Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervical Ripening Balloon + Oxytocin
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervical Ripening Balloon Alone
n=90 participants at risk
Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Oxytocin
|
Cervical Ripening Balloon + Oxytocin
n=90 participants at risk
Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Oxytocin
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Peripartum Hysterectomy
|
0.00%
0/90 • 36 hours
|
1.1%
1/90 • 36 hours
|
|
Pregnancy, puerperium and perinatal conditions
Unanticipated neonatal intensive care unit admission
|
0.00%
0/90 • 36 hours
|
1.1%
1/90 • 36 hours
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alison Bauer
University Hospitals Cleveland Medical Center
Phone: 216-844-3787
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place