Cervical Ripening, Induction of Labor
Conditions
Keywords
Cervical Ripening, Induction of Labor
Brief summary
In term women presenting for labor induction, combined use of the controlled release dinoprostone vaginal insert and Foley catheter for cervical ripening will decrease the median time from induction to vaginal delivery by at least four hours compared to the Foley catheter alone.
Detailed description
Those who provide informed consent will be allocated by an online randomization system either to placement of a transcervical Foley catheter and an intravaginal dinoprostone controlled release insert or a Foley catheter alone. Randomization will be stratified by parity (nulliparous or parous). In both study groups, the balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension. Also in both groups, the Foley catheter will be removed if any of the following occurs: 1) expulsion, 2) fetal heart rate tracing mandating evaluation for membrane rupture and placement of internal monitors, 3) spontaneous membrane rupture, or 4) if 12 hours has elapsed since placement. The dinoprostone insert will be removed if: 1) the fetal heart rate tracing mandates evaluation for membrane rupture and placement of internal monitors, 2) tachysystole develops (more than 5 contractions per 10 minutes averaged over 30 minutes, 3) spontaneous membrane rupture, or 4) 12 hours has elapsed since placement. Though these are the criteria for insert removal, in keeping with the pragmatic design of this trial, the decision regarding removal will be left to the discretion of the attending physician. Women will remain recumbent for 30 minutes after agent placement and, except for trips to the restroom, will undergo continuous monitoring of uterine contractions and fetal heart rate. Oxytocin, according to standard intravenous protocol, will be allowed only after removal of cervical ripening agent(s). After specified cervical ripening, labor management will be at the discretion of the attending obstetrician, in keeping with the pragmatic nature of the study design. Antibiotics will be administered if indicated for prophylaxis against early-onset neonatal infection with group B streptococci or for treatment of chorioamnionitis. Cesarean delivery will be performed, per the discretion of the attending obstetrician, for standard maternal or fetal indications. Medical records will be reviewed no less than 30 days after delivery. Demographic, intrapartum, and outcome data will be entered into a computerized database.
Interventions
DRUGCervidil 10 MG Vaginal Insert
Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system, an integral part of which is a long tape. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.
DEVICEFoley Catheter
The balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension.
Sponsors
Ferring Pharmaceuticals
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Cervix ≤2 cm dilated; if 2 cm, \<80% effaced 2. Gestational age 37 weeks or more 3. Singleton gestation 4. Cephalic presentation 5. Live fetus
Exclusion criteria
1. Contractions more frequent than every 5 minutes 2. Premature rupture of membranes 3. Prior uterine incision 4. Temperature 38C or higher 5. Fetal anomalies 6. Placenta previa 7. Suspected abruption or undiagnosed bleeding more than spotting 8. Fetal heart rate tracing prior to enrollment with no more than minimal variability, late decelerations, or more than two variable decelerations 9. HIV infection 10. Allergy to either latex or dinoprostone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Median Times From Placement of Foley Catheter to Vaginal Delivery | 48 hours | median time estimation for use of dinoprostone and foley catheter and foley catheter alone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours | 24 hours | To evaluate the proportion of patients that delivered vaginally by 12 hours and proportion of patients delivered vaginally by 24 hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nulliparous Foley Catheter & Dinoprostone Insert patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently | 26 |
| Nulliparous Foley Catheter Alone patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone | 24 |
| Parous Foley Catheter & Dinoprostone Insert patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently | 25 |
| Parous Foley Catheter Alone patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction with the intracervical Foley catheter alone | 25 |
| Total | 100 |
Baseline characteristics
| Characteristic | Nulliparous Foley Catheter & Dinoprostone Insert | Nulliparous Foley Catheter Alone | Parous Foley Catheter & Dinoprostone Insert | Parous Foley Catheter Alone | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 24 Participants | 25 Participants | 25 Participants | 100 Participants |
| BMI | 33 body mass index STANDARD_DEVIATION 1.5 | 35 body mass index STANDARD_DEVIATION 0.27 | 33.9 body mass index STANDARD_DEVIATION 6.8 | 34.8 body mass index STANDARD_DEVIATION 5.6 | 34.2 body mass index STANDARD_DEVIATION 3.4 |
| Chronic hyptertension | 3 Participants | 4 Participants | 2 Participants | 3 Participants | 12 Participants |
| Diabetes | 6 Participants | 7 Participants | 3 Participants | 2 Participants | 18 Participants |
| Fetal growth restriction | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Gestational age | 38.5 gestational age (weeks) STANDARD_DEVIATION 1.5 | 38.9 gestational age (weeks) STANDARD_DEVIATION 1.2 | 38.8 gestational age (weeks) STANDARD_DEVIATION 1.3 | 38.9 gestational age (weeks) STANDARD_DEVIATION 1.2 | 38.8 gestational age (weeks) STANDARD_DEVIATION 1.3 |
| Gestational hypertension | 5 Participants | 9 Participants | 8 Participants | 1 Participants | 23 Participants |
| Preeclampsia | 5 Participants | 0 Participants | 1 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 4 Participants | 2 Participants | 1 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic | 12 Participants | 6 Participants | 10 Participants | 13 Participants | 41 Participants |
| Race/Ethnicity, Customized Native American | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 13 Participants | 11 Participants | 8 Participants | 44 Participants |
| Sex: Female, Male Female | 26 Participants | 24 Participants | 25 Participants | 25 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 3 / 26 | 0 / 24 | 3 / 25 | 4 / 25 |
| serious Total, serious adverse events | 0 / 26 | 4 / 24 | 0 / 25 | 1 / 25 |
Outcome results
Primary
The Median Times From Placement of Foley Catheter to Vaginal Delivery
median time estimation for use of dinoprostone and foley catheter and foley catheter alone
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nulliparous Foley Catheter & Dinoprostone Insert | The Median Times From Placement of Foley Catheter to Vaginal Delivery | 21.2 hours |
| Nulliparous Foley Catheter Alone | The Median Times From Placement of Foley Catheter to Vaginal Delivery | 31.3 hours |
| Parous Foley Catheter & Dinoprostone Insert | The Median Times From Placement of Foley Catheter to Vaginal Delivery | 17.1 hours |
| Parous Foley Catheter Alone | The Median Times From Placement of Foley Catheter to Vaginal Delivery | 14.8 hours |
Secondary
To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours
To evaluate the proportion of patients that delivered vaginally by 12 hours and proportion of patients delivered vaginally by 24 hours.
Time frame: 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nulliparous Foley Catheter & Dinoprostone Insert | To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours | Delivered vaginally by 12 hours | 2 Participants |
| Nulliparous Foley Catheter & Dinoprostone Insert | To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours | Delivered vaginally by 24 hours | 15 Participants |
| Nulliparous Foley Catheter Alone | To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours | Delivered vaginally by 24 hours | 6 Participants |
| Nulliparous Foley Catheter Alone | To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours | Delivered vaginally by 12 hours | 1 Participants |
| Parous Foley Catheter & Dinoprostone Insert | To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours | Delivered vaginally by 12 hours | 3 Participants |
| Parous Foley Catheter & Dinoprostone Insert | To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours | Delivered vaginally by 24 hours | 19 Participants |
| Parous Foley Catheter Alone | To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours | Delivered vaginally by 12 hours | 6 Participants |
| Parous Foley Catheter Alone | To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours | Delivered vaginally by 24 hours | 21 Participants |