Cervical Ripening With Foley Bulb Versus Dilapan-S at Home (GOHOME)

Cervical Ripening With Foley Bulb Versus Dilapan-S at Home: a Randomized Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Induction of Labor Affected Fetus / Newborn; Induced; Birth
• Intervention / Treatment: Device: Foley bulb placement; Device: DILAPAN-S® placement

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Foley bulb; 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; 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.
Active Comparator: DILAPAN-S®; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Reasons for cesarean delivery include: non-reassuring fetal heart rate tracing, arrest of dilation, arrest of descent, failed induction of labor, maternal request, other	through study completion, an average of 2 years
Time from device insertion to delivery	Time from device (Foley bulb or Dilapan) insertion to delivery (vaginal or cesarean), hours	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
Rate of vaginal delivery within 36 hours of device insertion		through study completion, an average of 2 years
Time from device insertion to expulsion or extraction	Time from device (Foley bulb or Dilapan) insertion to spontaneous expulsion or device removal, hours	through study completion, an average of 2 years
Rate of device expulsion at home	Percentage of patients whose device (Foley bulb or Dilapan) was expelled at home	through study completion, an average of 2 years
Rate of patients that received Pitocin		through study completion, an average of 2 years
Average number of Dilapan dilator rods used	Multiple Dilapan rods may be placed for cervical dilation. The number of rods used is at the discretion of the clinician.	through study completion, an average of 2 years
Change in Bishop score before and after mechanical cervical ripening	Change in Bishop score from initial assessment to first exam following device expulsion/removal.	through study completion, an average of 2 years
Time from device insertion to active stage of labor	The active stage of labor is defined as cervical dilation greater than or equal to 6cm, hours	through study completion, an average of 2 years
Rate of artificial rupture of membranes		through study completion, an average of 2 years
Rate of epidural or spinal anesthesia during labor		through study completion, an average of 2 years
Rate of analgesia needed for device insertion	Analgesia methods may include butorphanol, neuraxial blockade, nitric oxide, etc.	through study completion, an average of 2 years
Rate of complications from device insertion	Complications include: incidental rupture of membranes, device malfunction/breakage, vaginal bleeding (defined as gross blood apparent on glove, perineum, vagina, or within Foley catheter lumen), cervical laceration, vasovagal reaction	through study completion, an average of 2 years
Rate of tachysystole	Defined as at least 6 contractions in 10 minutes for 2 consecutive 10-minute periods	through study completion, an average of 2 years
Rate of postpartum hemorrhage	Defined as 1,000 mL or blood loss accompanied by signs or symptoms of hypovolemia within 24 hours after the birth process	through study completion, an average of 2 years
Rate of shoulder dystocia		through study completion, an average of 2 years
Rate of suspected intraamniotic infection	Defined as the presence of maternal intrapartum fever and one or more of the following: maternal leukocytosis, purulent cervical drainage, or fetal tachycardia	through study completion, an average of 2 years
Rate of any serious maternal morbidity	Serious maternal morbidities include uterine rupture, admission to an intensive care unit, and sepsis	through study completion, an average of 2 years
Rate of maternal death		through study completion, an average of 2 years
Maternal satisfaction	A two-part maternal satisfaction survey will be administered immediately after device placement and then postpartum day one	through study completion, an average of 2 years
Rate of 1 minute Apgar score < 5	Rate of 1 minute Apgar score less than 5	through study completion, an average of 2 years
Rate of 5 minute Apgar score < 7	Rate of 5 minute Apgar score less than 7	through study completion, an average of 2 years
Rate of NICU admission	Rate of neonates admitted to the NICU	through study completion, an average of 2 years
Rate of NICU admission > 48 hours	Rate of neonates requiring NICU admission for longer than 48 hours	through study completion, an average of 2 years
NICU length of stay	Length of NICU admission, days	through study completion, an average of 2 years
Rate of any adverse neonatal outcome	Includes death, severe respiratory distress syndrome (defined as intubation and mechanical ventilation for a minimum of 12 hours), hypoxic-ischemic encephalopathy, seizure, culture-proven neonatal sepsis, birth trauma (bone fracture, intracranial hemorrhage, neurologic injury, retinal hemorrhage), hypotension requiring vasopressor support, receipt of total body cooling.	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Collaborators: Medicem International CR s.r.o.; Medicem Technology s.r.o.
• Investigators: Principal Investigator: Anthony C Sciscione, DO, Christiana Care Health Services

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DDD#604684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes