Cervical Ripening
Conditions
Brief summary
The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in conjunction with low dose oxytocin is more effective at shortening labor induction times than the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be randomly divided into a Balloon with oxytocin or Balloon only group. The Balloon will be placed by either Resident or Attending Physicians and left in place for 12 hours (protocol) in both groups or until it falls out. After either 12 hours or the Balloon falls out, oxytocin will be used for the remainder of the induction per current hospital protocol. Time to delivery, mode of delivery, average number of hours Balloon remained in place, non-reassuring fetal heart tracings, adverse outcomes (ie fetal malpresentation, postpartum hemorrhage) will be recorded.
Interventions
DEVICECook catheter
DRUGOxytocin
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. singleton pregnancy 2. reassuring fetal status at time of presentation 3. Bishop Score \<6
Exclusion criteria
1. Closed cervix 2. Breech presentation 3. Multiple gestations 4. Recent vaginal bleeding 5. Placenta previa 6. non reassuring fetal status 7. Active genital herpes infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Delivery (in Hours) | Up to 60 hours | Cook Only group Cook + Pitocin group N Mean (hrs) (SD) 16 27.9 (9.6) 10 23 14.6) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cook Catheter Control
Cook catheter | 16 |
| Cook Catheter Plus Low Dose Oxytocin Test group
Cook catheter
Oxytocin | 10 |
| Total | 26 |
Baseline characteristics
| Characteristic | Cook Catheter Plus Low Dose Oxytocin | Total | Cook Catheter |
|---|---|---|---|
| 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 | 10 Participants | 26 Participants | 16 Participants |
| Age, Continuous | 24 years STANDARD_DEVIATION 1.3 | 23 years STANDARD_DEVIATION 1.2 | 22 years STANDARD_DEVIATION 1.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 23 Participants | 14 Participants |
| Region of Enrollment United States | 10 Participants | 26 Participants | 16 Participants |
| Sex: Female, Male Female | 10 Participants | 26 Participants | 16 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 / 16 | 0 / 10 |
| other Total, other adverse events | 0 / 16 | 0 / 10 |
| serious Total, serious adverse events | 0 / 16 | 0 / 10 |
Outcome results
Primary
Time to Delivery (in Hours)
Cook Only group Cook + Pitocin group N Mean (hrs) (SD) 16 27.9 (9.6) 10 23 14.6)
Time frame: Up to 60 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cook Catheter | Time to Delivery (in Hours) | 27 hours |
| Cook Catheter Plus Low Dose Oxytocin | Time to Delivery (in Hours) | 23 hours |
p-value: 0.208Wilcoxon (Mann-Whitney)