Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix (CORC)

This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.

Study Overview

• Status: Terminated
• Conditions: Induction of Labor
• Intervention / Treatment: Device: Trans-cervical cervical balloon; Device: Hygroscopic cervical dilator

Detailed Description

Term, low risk patients requesting elective induction of labor who desire pre-induction cervical ripening at home will be randomized to receive an outpatient trans-cervical ripening balloon (17 F non-latex Foley catheter) or hygroscopic cervical dilator (Dilapan-S). Patients present to the hospital for their scheduled induction of labor approximately 12 hours later.

We hypothesize that the trans-cervical balloon and hygroscopic dilators will show equivalent efficacy in cervical ripening, but that pain scores and patient satisfaction will be better with the hygroscopic dilators.

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Ochsner Baptist Hospital
  • New York
    • Bay Shore, New York, United States, 11706
      • Brigid McCue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women between 39 and 41 weeks gestational age who desire elective induction of labor, based on reliable estimated gestational age (defined as ultrasonography performed before 14 weeks 0 days, or a certain last menstrual period consistent with ultrasonography performed before 21 weeks 0 days).

Exclusion Criteria:

• 1. Risk factors for placental insufficiency or intra-partum complication such as intra-uterine growth restriction, hypertensive disease, diabetes requiring insulin therapy, multiple gestation, history of previous hysterotomy, cholestasis of pregnancy, placental abnormalities including low lying placenta (< 2 cm from cervical os), maternal cardiac disease, maternal pulmonary disease, known fetal anomaly, fetal demise, etc.
• 2. Simplified Bishop score must be <6 and cervical dilation <2 cm.
• 3. Women must be able to give informed consent.
• 4. Concern regarding fetal well-being, conditions which preclude vaginal birth, group B strep carriers, patients who are HIV, Hep B or Hep C positive.
• 5. Women allergic to povidone-iodine, aquacryl hydrogel or the latex-free Foley catheter.

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
Experimental: Trans-cervical cervical balloon; 17 F non-latex Foley catheter will be placed and balloon filled with 30 cc of sterile normal saline.	Device: Trans-cervical cervical balloon; Insertion of Foley Catheter
Experimental: Hygroscopic cervical dilators; Dilapan-S hygroscopic dilators will be placed into the cervix at the level of the internal os.	Device: Hygroscopic cervical dilator; Insertion of Dilapan-s

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from start of cervical ripening to delivery	Time in minutes from placement of cervical ripening agent to delivery	720-2160 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain of insertion	Patient assessment of pain on insertion using pain analog scale	First hour
Pain over duration of cervical ripening	Patient assessment of pain on admission using pain analog scale	12-14 hours
Patient satisfaction with cervical ripening agent	Patient survey postpartum day #1 regarding cervical ripening experience	24-36 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of device expulsion prior to admission	Number of patients reporting expulsion of the device prior to planned admission	12-14 hours
Rate of onset of labor prior to planned admission	Number of patients presenting in active labor prior to planned admission divided by all enrolled patients	12-14 hours
Rate of cesarean delivery	Number of patients requiring cesarean delivery divided by number of all enrolled patients	12-36 hours
Rate of operative vaginal delivery	Number of patients requiring operative vaginal delivery divided by number of all enrolled patients	12-36 hours
Incidence of shoulder dystocia	Number of patients diagnosed with shoulder dystocia divided by number of all enrolled patients	12-36 hours
Incidence of intra-amniotic infection	Number of patients diagnosed with intra-amniotic infection (maternal temperature >38C, maternal (>120) or fetal (>160) tachycardia) divided by number of all enrolled patients	12-36 hours
Incidence of post-partum hemorrhage	Number of patients diagnosed with post-partu hemorrhage (QBL >1000 ml) divided by number of all enrolled patients	12-36 hours
10 minute Apgar score <7	Number of infants with 10 minute Apgar score <7 divided by number of all enrolled patients	12-36 hours
Base excess >12	Number of infants with base excess >12 divided by number of all enrolled patients	12-36 hours
Umbilical cord gas pH <7	Number of infants with umbilical cord gas <7 divided by number of all enrolled patients	12-36 hours
Composite score of adverse neonatal outcomes	Composite of perinatal adverse outcomes (the need for respiratory support within 72 hours after birth, Apgar score of 3 or less at 5 minutes, hypoxic-ischemic encephalopathy, seizure, infection (confirmed sepsis or pneumonia), aspiration syndrome, birth trauma (bone fracture, neurologic injury, or retinal hemorrhage), intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support)	12-72 hours
Composite score of serious maternal morbidity or mortality	Composite score of serious maternal morbidity (e.g. uterine rupture, admission to intensive care unit, septicemia), or death.	12-72 hours

Collaborators and Investigators

• Sponsor: Ochsner Health System
• Collaborators: Northwell Health
• Investigators: Principal Investigator: Brigid McCue, MD, Northwell Health

Publications and helpful links

General Publications

• Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
• 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.
• Gilson GJ, Russell DJ, Izquierdo LA, Qualls CR, Curet LB. A prospective randomized evaluation of a hygroscopic cervical dilator, Dilapan, in the preinduction ripening of patients undergoing induction of labor. Am J Obstet Gynecol. 1996 Jul;175(1):145-9. doi: 10.1016/s0002-9378(96)70264-8.
• Shindo R, Aoki S, Yonemoto N, Yamamoto Y, Kasai J, Kasai M, Miyagi E. Hygroscopic dilators vs balloon catheter ripening of the cervix for induction of labor in nulliparous women at term: Retrospective study. PLoS One. 2017 Dec 22;12(12):e0189665. doi: 10.1371/journal.pone.0189665. eCollection 2017.
• Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JM, Mazzoni SE, Wang MJ, Files P, Tita AT, Subramaniam A, Harper LM. Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):94-101. doi: 10.1097/AOG.0000000000002678.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00000397

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.: No