Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix

Induction of Labor Clinical Trial

— CORC  

Official title:

Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03752073
• Other study ID #: STUDY00000397
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2023
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 185
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Device:
• Trans-cervical cervical balloon
Insertion of Foley Catheter
• Hygroscopic cervical dilator
Insertion of Dilapan-s

Locations

Country	Name	City	State
United States	Brigid McCue	Bay Shore	New York
United States	Ochsner Baptist Hospital	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Ochsner Health System	Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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):94-1 — View 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of device expulsion prior to admission	Number of patients reporting expulsion of the device prior to planned admission	12-14 hours
Other	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
Other	Rate of cesarean delivery	Number of patients requiring cesarean delivery divided by number of all enrolled patients	12-36 hours
Other	Rate of operative vaginal delivery	Number of patients requiring operative vaginal delivery divided by number of all enrolled patients	12-36 hours
Other	Incidence of shoulder dystocia	Number of patients diagnosed with shoulder dystocia divided by number of all enrolled patients	12-36 hours
Other	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
Other	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
Other	10 minute Apgar score <7	Number of infants with 10 minute Apgar score <7 divided by number of all enrolled patients	12-36 hours
Other	Base excess >12	Number of infants with base excess >12 divided by number of all enrolled patients	12-36 hours
Other	Umbilical cord gas pH <7	Number of infants with umbilical cord gas <7 divided by number of all enrolled patients	12-36 hours
Other	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
Other	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
Primary	Time from start of cervical ripening to delivery	Time in minutes from placement of cervical ripening agent to delivery	720-2160 minutes
Secondary	Pain of insertion	Patient assessment of pain on insertion using pain analog scale	First hour
Secondary	Pain over duration of cervical ripening	Patient assessment of pain on admission using pain analog scale	12-14 hours
Secondary	Patient satisfaction with cervical ripening agent	Patient survey postpartum day #1 regarding cervical ripening experience	24-36 hours