Cervical Ripening, Induction of Labor, Multiparity
Conditions
Brief summary
Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix. Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing morbidity or increasing the need for operative delivery.
Interventions
DRUGOxytocin
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \> 18 years * Gestational age \> 34 + 0/7 weeks * Prior spontaneous vaginal delivery * Clinical or U/S EFW of \<4500 grams * Singleton gestation * Cervical dilation \<2 cm
Exclusion criteria
* Any contraindication to cervical ripening balloon, pitocin, or vaginal delivery * Placenta within 2 cm of cervical os * Placental abruption, chorioamninoitis, or systemic infection prior to induction * Rupture of membranes prior to induction -\>1 prior C/S
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Cervical Ripening to Delivery | Time to delivery | Time from placement of cervical ripening balloon to delivery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 90 |
| 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 | 90 |
| Total | 180 |
Baseline characteristics
| Characteristic | Cervical Ripening Balloon Alone | Cervical Ripening Balloon + Oxytocin | Total |
|---|---|---|---|
| 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 | 90 Participants | 90 Participants | 180 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 77 Participants | 76 Participants | 153 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 | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 9 Participants | 13 Participants | 22 Participants |
| Region of Enrollment United States | 90 participants | 90 participants | 180 participants |
| Sex: Female, Male Female | 90 Participants | 90 Participants | 180 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 / 90 | 0 / 90 |
| other Total, other adverse events | 0 / 90 | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 | 2 / 90 |
Outcome results
Primary
Time From Cervical Ripening to Delivery
Time from placement of cervical ripening balloon to delivery
Time frame: Time to delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cervical Ripening Balloon Alone | Time From Cervical Ripening to Delivery | 16.88 hours |
| Cervical Ripening Balloon + Oxytocin | Time From Cervical Ripening to Delivery | 13.13 hours |