Pre-induction Dilation of Cervix
Conditions
Keywords
Labor, Foley, Dilapan, Cervical Dilators, Induction
Brief summary
Women undergoing mechanical cervical ripening for labor induction will be randomized to Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.
Detailed description
Historically, mechanical methods were the first methods developed to ripen the cervix or to induce labor. Dilapan-S® a synthetic osmotic cervical dilator made of a patented hydrogel (AQUACRYL), works by stimulating the release of endogenous prostaglandins, which degrade collagen fibers and soften the cervix. Additionally, it dilates the cervix gradually and the effect is gentle as well as predictable. Recently, Dilapan-S® has been approved by the FDA as a mechanical dilator for cervical ripening. There are no data comparing this newly approved Dilapan-S® to the Foley catheter, the most commonly used mechanical dilator method. Therefore, The investigators propose a randomized controlled trial to determine the efficacy of Dilapan-S® compared with Foley catheter for cervical ripening before induction of labor in pregnant women greater than 37 weeks.
Interventions
DEVICEDilapan
Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
DEVICEFoley Catheter
Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.
Sponsors
Medicem International CR s.r.o.
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant woman scheduled for induction of labor. * Age between 18 and 45 years. * Understanding and capable to sign informed consent. * Singleton pregnancy. * Gestational age ≥ 37 0/7 weeks. * Live fetus in cephalic presentation. * Intact membranes. * Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced.
Exclusion criteria
* Iodine allergy. * Active labor or oxytocin has been administered. * Chorioamnionitis. * Prior uterine or cervical surgery. * Non reassuring fetal status requiring immediate delivery. * Non-cephalic fetal presentation. * Active vaginal bleeding from cervical os. * Placenta previa. * EFW \> 5000 gm(non diabetic) or \> 4500gm (diabetic). * Other contraindication to vaginal delivery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Vaginal Delivery | Through study completion, an average of 1-2 years | Proportion of patients that delivered vaginal. (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of Vaginal Delivery | 2-4 days | Delivery time frame in mins from cervical dilator insertion |
| Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation | 1-2 days | time from hospital admission to reach active stage of labor defined as ≥ 6 cm (mins) |
| Change in Bishop Scores | 12-24 hrs | Change in Bishop score from insertion to extraction of device. The total score is calculated by assessing the following five components on manual vaginal examination by a trained professional: Cervical dilation in centimeters. Cervical effacement as a percentage. Cervical consistency by provider assessment/judgement. The highest possible score is 13 and the lowest possible score is 0. Bishop scores of less than 6 usually require that a cervical ripening method (pharmacologic or physical, such as a foley bulb) be used before other method |
| Operative Deliveries | 1-4 days | Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance. |
| Cesarean Deliveries | 1-4 days | Proportion of patients that delivered by cesarean (%). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device Placement to Delivery Interval | 1-4 days | Interval from device placement to delivery (mins) |
| Time After Mechanical Dilator | 1-2 days | Induction (Oxytocin/Prostaglandin initiation) to delivery interval (mins) |
| Analgesia Requirement | 1-2 days | Rate of women who require any analgesia used during insertion of the device |
| Device Complications | 1-2 days | Rates of complications resulting from device insertion (%): Vaginal bleeding Vaso-vagal reaction from manipulation of the cervix Cervical laceration Retraction into the uterine cavity Rupture of membranes (Date/Time) Entrapment of the device Fragmentation of the device in the genital tract Rates of complications associated with cervical ripening(%) Uterine tachysystole/hypertonus Non reassuring fetal status Systemic adverse events (nausea, vomiting, diarrhea, fever, hypotension, tachycardia) |
| Comparison of Labor Curves Between Both Interventions | 1-2 days | Labor curves using Kaplan Meier method comparing Dilapan-S to Foley balloon |
| Spontaneous Labor | 1-4 days | Rate of women underwent spontaneous labor (%) |
| Pharmacological Agents for Labor Induction (Prostaglandins, Oxytocin)(%) | 1-2 days | Rate of women that required pharmacological cervical ripening agents (%) requirement (%) |
| Artificial Rupture of Membranes (AROM) | 1-2 days | Rate of women that had artificial rupture of membranes (AROM) (%) |
| Regional Anesthesia | 1-2 days | Rate of epidural/spinal analgesia (%) |
| Device Insertion Time | 1-2 days | Total duration of Dilapan-S® /Foley catheter insertion (mins) |
Countries
United States
Participant flow
Recruitment details
From November 2016 to February 2018 at UTMB Galveston
Participants by arm
| Arm | Count |
|---|---|
| Foley Bulb Group Patients will have a Foley catheter inserted into the internal cervical os.
Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl. | 209 |
| Dilapan Group Patients will have Dilapan sticks inserted into the internal cervical os.
Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os. | 210 |
| Total | 419 |
Baseline characteristics
| Characteristic | Foley Bulb Group | Dilapan Group | Total |
|---|---|---|---|
| Age, Continuous | 25 years | 25 years | 25 years |
| Bishop score at randomization | 3 scores on a scale | 3 scores on a scale | 3 scores on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 147 Participants | 153 Participants | 300 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 57 Participants | 119 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational age | 39.0 weeks | 39 weeks | 39 weeks |
| Nulliparous | 98 Participants | 88 Participants | 186 Participants |
| Region of Enrollment United States | 209 participants | 210 participants | 419 participants |
| Sex: Female, Male Female | 209 Participants | 210 Participants | 419 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 / 209 | 0 / 208 |
| other Total, other adverse events | 0 / 209 | 0 / 208 |
| serious Total, serious adverse events | 2 / 209 | 0 / 208 |
Outcome results
Primary
Rate of Vaginal Delivery
Proportion of patients that delivered vaginal. (%)
Time frame: Through study completion, an average of 1-2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foley Bulb Group | Rate of Vaginal Delivery | 169 Participants |
| Dilapan Group | Rate of Vaginal Delivery | 159 Participants |
Secondary
Cesarean Deliveries
Proportion of patients that delivered by cesarean (%).
Time frame: 1-4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foley Bulb Group | Cesarean Deliveries | 50 Participants |
| Dilapan Group | Cesarean Deliveries | 39 Participants |
Secondary
Change in Bishop Scores
Change in Bishop score from insertion to extraction of device. The total score is calculated by assessing the following five components on manual vaginal examination by a trained professional: Cervical dilation in centimeters. Cervical effacement as a percentage. Cervical consistency by provider assessment/judgement. The highest possible score is 13 and the lowest possible score is 0. Bishop scores of less than 6 usually require that a cervical ripening method (pharmacologic or physical, such as a foley bulb) be used before other method
Time frame: 12-24 hrs
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Foley Bulb Group | Change in Bishop Scores | 3 score on a scale |
| Dilapan Group | Change in Bishop Scores | 2 score on a scale |
Secondary
Operative Deliveries
Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
Time frame: 1-4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foley Bulb Group | Operative Deliveries | 6 Participants |
| Dilapan Group | Operative Deliveries | 9 Participants |
Secondary
Time of Vaginal Delivery
Delivery time frame in mins from cervical dilator insertion
Time frame: 2-4 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Foley Bulb Group | Time of Vaginal Delivery | 1291 minutes |
| Dilapan Group | Time of Vaginal Delivery | 1441 minutes |
Secondary
Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation
time from hospital admission to reach active stage of labor defined as ≥ 6 cm (mins)
Time frame: 1-2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Foley Bulb Group | Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation | 1011 minutes |
| Dilapan Group | Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation | 1152 minutes |
Other Pre-specified
Analgesia Requirement
Rate of women who require any analgesia used during insertion of the device
Time frame: 1-2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foley Bulb Group | Analgesia Requirement | 38 Participants |
| Dilapan Group | Analgesia Requirement | 34 Participants |
Other Pre-specified
Artificial Rupture of Membranes (AROM)
Rate of women that had artificial rupture of membranes (AROM) (%)
Time frame: 1-2 days
Other Pre-specified
Comparison of Labor Curves Between Both Interventions
Labor curves using Kaplan Meier method comparing Dilapan-S to Foley balloon
Time frame: 1-2 days
Other Pre-specified
Device Complications
Rates of complications resulting from device insertion (%): Vaginal bleeding Vaso-vagal reaction from manipulation of the cervix Cervical laceration Retraction into the uterine cavity Rupture of membranes (Date/Time) Entrapment of the device Fragmentation of the device in the genital tract Rates of complications associated with cervical ripening(%) Uterine tachysystole/hypertonus Non reassuring fetal status Systemic adverse events (nausea, vomiting, diarrhea, fever, hypotension, tachycardia)
Time frame: 1-2 days
Other Pre-specified
Device Insertion Time
Total duration of Dilapan-S® /Foley catheter insertion (mins)
Time frame: 1-2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foley Bulb Group | Device Insertion Time | 666 minutes | Standard Deviation 319 |
| Dilapan Group | Device Insertion Time | 774.1 minutes | Standard Deviation 295 |
Other Pre-specified
Device Placement to Delivery Interval
Interval from device placement to delivery (mins)
Time frame: 1-4 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Foley Bulb Group | Device Placement to Delivery Interval | 1291 minutes |
| Dilapan Group | Device Placement to Delivery Interval | 1441 minutes |
Other Pre-specified
Pharmacological Agents for Labor Induction (Prostaglandins, Oxytocin)(%)
Rate of women that required pharmacological cervical ripening agents (%) requirement (%)
Time frame: 1-2 days
Other Pre-specified
Regional Anesthesia
Rate of epidural/spinal analgesia (%)
Time frame: 1-2 days
Other Pre-specified
Spontaneous Labor
Rate of women underwent spontaneous labor (%)
Time frame: 1-4 days
Other Pre-specified
Time After Mechanical Dilator
Induction (Oxytocin/Prostaglandin initiation) to delivery interval (mins)
Time frame: 1-2 days