Clinical trial NCT03752073: Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix
Official title: Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Induction of Labor
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: Northwell Health
First posted: 2018-11-23
Enrollment: 185
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time from start of cervical ripening to delivery
timeFrame: 720-2160 minutes
Secondary outcomes:
measure: Pain of insertion
timeFrame: First hour
measure: Pain over duration of cervical ripening
timeFrame: 12-14 hours
measure: Patient satisfaction with cervical ripening agent
timeFrame: 24-36 hours
Other outcomes:
measure: Rate of device expulsion prior to admission
timeFrame: 12-14 hours
measure: Rate of onset of labor prior to planned admission
timeFrame: 12-14 hours
measure: Rate of cesarean delivery
timeFrame: 12-36 hours
measure: Rate of operative vaginal delivery
timeFrame: 12-36 hours
measure: Incidence of shoulder dystocia
timeFrame: 12-36 hours
measure: Incidence of intra-amniotic infection
timeFrame: 12-36 hours
measure: Incidence of post-partum hemorrhage
timeFrame: 12-36 hours
measure: 10 minute Apgar score <7
timeFrame: 12-36 hours
measure: Base excess >12
timeFrame: 12-36 hours
measure: Umbilical cord gas pH <7
timeFrame: 12-36 hours
measure: Composite score of adverse neonatal outcomes
timeFrame: 12-72 hours
measure: Composite score of serious maternal morbidity or mortality
timeFrame: 12-72 hours
Locations:
city: New Orleans
country: United States
facility: Ochsner Baptist Hospital
state: Louisiana
city: Bay Shore
country: United States
facility: Brigid McCue
state: New York
Study officials:
affiliation: Northwell Health
name: Brigid McCue, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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: 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.
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.
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):94-101. doi: 10.1097/AOG.0000000000002678.