Cervical Ripening With Foley Bulb Versus Dilapan-S at Home

NCT04739683 | Withdrawn DMC FDA Device

• 1 other identifier: DDD#604684
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Induced; Birth; Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

• Time spent on the labor and delivery unit

  Length of time spent on the labor and delivery unit, hours

  through study completion, an average of 2 years

Secondary Outcomes (29)

• Rate of vaginal delivery

  through study completion, an average of 2 years

• Rate of cesarean delivery

  through study completion, an average of 2 years

• Indication for cesarean delivery

  through study completion, an average of 2 years

• Time from device insertion to delivery

  through study completion, an average of 2 years

• Rate of vaginal delivery within 24 hours of device insertion

  through study completion, an average of 2 years

Study Arms (2)

Foley bulb

ACTIVE COMPARATOR

16F latex or silicone Foley catheter inflated with 30-40 cc of sterile water. The catheter will be taped to the inner thigh with gentle traction.

Device: Foley bulb placement

DILAPAN-S®

ACTIVE COMPARATOR

Synthetic hydrogel cervical dilator consists of the dilating part, the polypropylene handle, and the marker string. The dilating part is manufactured from an anisotropic xerogel of AQUACRYL.

Device: DILAPAN-S® placement

Interventions

Foley bulb placement DEVICE

A 16 F Foley catheter with a 30-mL balloon and stylet is inserted into the endocervical canal under direct visualization by sterile speculum exam or by digital palpation. The Foley catheter is advanced to or past the internal os, and the balloon is filled with 30-40 mL of sterile water. The catheter is then placed on genital traction by taping the end of the catheter to the medial portion of the thigh.

Foley bulb

DILAPAN-S® placement DEVICE

A bivalve speculum will be used to visualize and prepare the cervix with an antiseptic solution. The DILAPAN-S® (4 x 65 mm) will be inserted in the cervical canal until it traverses the internal os. As many dilators as needed to achieve the desired effect should be inserted. Specific number of pieces always depends on decision and clinical judgement of physician and indications. A gauze pad moistened with sterile water or saline may be inserted into the vagina to help keep the DILAPAN-S® in place, if needed

DILAPAN-S®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Christiana Care Health Services: lead
• Medicem International CR s.r.o.: collaborator
• Medicem Technology s.r.o.: collaborator

Related Publications (6)

• 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.

  PMID: 30089070 BACKGROUND

• 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.

  PMID: 30790569 BACKGROUND

• 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.

  PMID: 30674049 BACKGROUND

• 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.

  PMID: 24347259 BACKGROUND

• 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.

  PMID: 19623003 BACKGROUND

• Albers LL. The duration of labor in healthy women. J Perinatol. 1999 Mar;19(2):114-9. doi: 10.1038/sj.jp.7200100.

  PMID: 10642971 BACKGROUND

Study Officials

• Anthony C Sciscione, DO

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician-Perinatology

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 5, 2021
• Study Start: June 30, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share