Clinical trial NCT04739683: Cervical Ripening With Foley Bulb Versus Dilapan-S at Home
Official title: Cervical Ripening With Foley Bulb Versus Dilapan-S at Home: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Induced; Birth
Induction of Labor Affected Fetus / Newborn
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Medicem International CR s.r.o.
name: Medicem Technology s.r.o.
First posted: 2021-02-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: DILAPAN-S® was FDA-approved for pre-induction cervical ripening in 2015. Since that time, there have been limited studies comparing its efficacy, safety, and patient satisfaction to other mechanical cervical ripening techniques. The purpose of this trial is to perform a noninferiority randomized clinical trial comparing DILAPAN-S® to the Foley catheter for outpatient cervical ripening in term elective labor inductions, examining time spent on the labor and delivery unit, patient safety, and patient satisfaction feedback.

Detailed description: In 2019, Grobman et al, published the ARRIVE trial showing that labor inductions without medical indication at 39 weeks gestation are associated with improved maternal and perinatal outcomes compared to expectant management.1 In the wake of these landmark findings, labor inductions without medical indication are becoming increasingly common not only on a nation scale, but locally as well. Recent data show that labor inductions without medical indication encompass nearly one third of all inductions at Christiana Care Health System.

Labor induction can include both mechanical and pharmacological measures to ripen the cervix and stimulate uterine contractions. The ultimate challenge, which has been the focus of numerous studies to date, is to determine which mechanical and/or pharmacological products and which clinical settings are safest and most efficacious for inducing labor.

Currently, transcervical Foley catheters are the gold-standard mechanical method of cervical ripening. However, new-emerging data has shown that hygroscopic cervical dilators, traditionally used for early pregnancy termination, may be a viable alternative. DILAPAN-S® , a hygroscopic dilator composed of a synthetic hydrogel was approved by the Food and Drug Administration for cervical ripening in 2015 and has been the subject of recent investigation. In a single-center, randomized, open-label trial consisting of 419 patients, Saad et al showed that DILAPAN-S® is not inferior to the Foley catheter for pre-induction cervical ripening at term; there was no significant difference in maternal and neonatal adverse events and patients with DILAPAN-S® were more satisfied than patients with the Foley catheter as far as sleep, relaxing time, and performance of desired daily activities.2

Furthermore, in the pursuit of improving patient satisfaction with consideration of healthcare resources, studies have investigated the safety and efficacy of outpatient mechanical cervical ripening.3 Sciscione et al, showed that in a low-risk population of 1,905 patients, no adverse outcomes were associated with outpatient Foley catheter cervical ripening and patients on average avoided 9.6 hours of hospitalizations compared to the inpatient group.4 The ACOG practice bulletin on induction of labor now states that outpatient cervical ripening, particularly mechanical methods, may be appropriate in select patients.5 Based on the literature cited above, it is plausible to hypothesize that DILAPAN-S® used for outpatient cervical ripening may optimize patient satisfaction and healthcare resource utilization without compromising patient safety and efficacy. The purpose of this trial is to perform a noninferiority randomized clinical trial comparing DILAPAN-S® to the Foley catheter for outpatient cervical ripening in term elective labor inductions, examining time spent on the labor and delivery unit, patient safety, and patient satisfaction feedback.

Eligibility criteria: Inclusion Criteria:

* Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically is not eligible unless the reduction occurred before 14 weeks 0 days gestational age.
* Gestational age at randomization between 39 weeks and 40 weeks 6 days (based on reliable EGA defined as ultrasound performed before 14 weeks 0 days, or a certain LMP consistent with ultrasonography before 21 weeks and 0 days.)
* Patient prefers outpatient cervical ripening
* Patient lives within a one-hour commute from the hospital.

Exclusion Criteria:

* Project gestational age at date of first ultrasound is \> 20 weeks 6 days
* Refusal of blood products
* Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
* Delivery planned elsewhere at a non-Christiana site
* Major maternal medical illness associated with increased risk for adverse pregnancy outcomes that would preclude her from an outpatient induction (e.g. any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)
* Medical indication for induction prior to 40 weeks 5 days due to any maternal
* Heparin or low-molecular weight heparin use during the current pregnancy
* Cerclage in current pregnancy
* Prior uterine or cervical surgery (cesarean, myomectomy, cerclage, LEEP, cone biopsy, etc.)
* Known HIV positivity because of modified delivery plan
* Iodine or latex allergy
* Fetal demise or known major fetal anomaly
* Medical indication for induction prior to 40 weeks 5 days due to any fetal condition
* Known oligohydramnios, defined as amniotic fluid index \< 5 cm or maximal vertical pocket \< 2 cm
* Fetal growth restriction, defined as EFW \< 10th percentile
* Plan for cesarean delivery or contraindication to labor
* Nonvertex fetal presentation
* Placenta previa, placenta accrete, or vasa previa
* Active genital herpes lesions
* Cervical dilation greater than 3 cm on initial evaluation
* Signs of labor (regular painful contractions with cervical change) on initial evaluation
* Active vaginal bleeding greater than bloody show on initial evaluation
* Ruptured membranes on initial evaluation
* Non-reassuring fetal status (category II or III fetal heart rate tracing) on initial evaluation

Primary outcomes:
measure: Time spent on the labor and delivery unit
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Rate of vaginal delivery
timeFrame: through study completion, an average of 2 years
measure: Rate of cesarean delivery
timeFrame: through study completion, an average of 2 years
measure: Indication for cesarean delivery
timeFrame: through study completion, an average of 2 years
measure: Time from device insertion to delivery
timeFrame: through study completion, an average of 2 years
measure: Rate of vaginal delivery within 24 hours of device insertion
timeFrame: through study completion, an average of 2 years
measure: Rate of vaginal delivery within 36 hours of device insertion
timeFrame: through study completion, an average of 2 years
measure: Time from device insertion to expulsion or extraction
timeFrame: through study completion, an average of 2 years
measure: Rate of device expulsion at home
timeFrame: through study completion, an average of 2 years
measure: Rate of patients that received Pitocin
timeFrame: through study completion, an average of 2 years
measure: Average number of Dilapan dilator rods used
timeFrame: through study completion, an average of 2 years
measure: Change in Bishop score before and after mechanical cervical ripening
timeFrame: through study completion, an average of 2 years
measure: Time from device insertion to active stage of labor
timeFrame: through study completion, an average of 2 years
measure: Rate of artificial rupture of membranes
timeFrame: through study completion, an average of 2 years
measure: Rate of epidural or spinal anesthesia during labor
timeFrame: through study completion, an average of 2 years
measure: Rate of analgesia needed for device insertion
timeFrame: through study completion, an average of 2 years
measure: Rate of complications from device insertion
timeFrame: through study completion, an average of 2 years
measure: Rate of tachysystole
timeFrame: through study completion, an average of 2 years
measure: Rate of postpartum hemorrhage
timeFrame: through study completion, an average of 2 years
measure: Rate of shoulder dystocia
timeFrame: through study completion, an average of 2 years
measure: Rate of suspected intraamniotic infection
timeFrame: through study completion, an average of 2 years
measure: Rate of any serious maternal morbidity
timeFrame: through study completion, an average of 2 years
measure: Rate of maternal death
timeFrame: through study completion, an average of 2 years
measure: Maternal satisfaction
timeFrame: through study completion, an average of 2 years
measure: Rate of 1 minute Apgar score < 5
timeFrame: through study completion, an average of 2 years
measure: Rate of 5 minute Apgar score < 7
timeFrame: through study completion, an average of 2 years
measure: Rate of NICU admission
timeFrame: through study completion, an average of 2 years
measure: Rate of NICU admission > 48 hours
timeFrame: through study completion, an average of 2 years
measure: NICU length of stay
timeFrame: through study completion, an average of 2 years
measure: Rate of any adverse neonatal outcome
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Christiana Care Health Services
name: Anthony C Sciscione, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
citation: Saad AF, Villarreal J, Eid J, Spencer N, Ellis V, Hankins GD, Saade GR. A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial). Am J Obstet Gynecol. 2019 Mar;220(3):275.e1-275.e9. doi: 10.1016/j.ajog.2019.01.008. Epub 2019 Feb 18.
citation: Levine LD, Sciscione AC. Foley Catheter for Outpatient Cervical Ripening: Review of the Evidence and a Proposed Model of Care. Am J Perinatol. 2019 Dec;36(14):1528-1532. doi: 10.1055/s-0038-1677473. Epub 2019 Jan 23. No abstract available.
citation: Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17.
citation: ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
citation: Albers LL. The duration of labor in healthy women. J Perinatol. 1999 Mar;19(2):114-9. doi: 10.1038/sj.jp.7200100.