NCT03934918

Brief Summary

This study is to compare 2 groups in nulliparous women undergoing cervical ripening for induction of labor. The study hypothesis is that outpatient cervical preparation with a foley catheter can reduce the induction of labor (IOL) time interval from admission to delivery by 50%. A 30 ml transcervical foley catheter is a safe mode of cervical preparation in the outpatient setting, as concluded in Diederen et al, Sciscinoe et al, and Kelly et al. Findings from studies on nulliparous, term, singleton vertex (NTSV) showed patients can be applied to a wide variety of maternity unit sizes as discussed by Main et al. No previous study has evaluated the effectiveness of outpatient cervical preparation in the NTSV population by PUBMED search. Further, no previous study has assessed patient satisfaction cervical preparation in the outpatient setting and no previous study has evaluated whether outpatient cervical preparation has an impact on the length of stay and cost of hospitalization. This study will explore these important questions with the goal of improving current practices in labor induction to be more patient-centered, pragmatic, and cost-effective.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

April 5, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

April 18, 2019

Last Update Submit

March 31, 2021

Conditions

Cervical RipeningOutpatientPatient SatisfactionNulliparousLength of Stay

Keywords

cervical preparationcervical ripeningNTSVinduction of labor

Outcome Measures

Primary Outcomes (1)

  • Duration of time from admission for IOL to delivery

    The time difference from admission to delivery of the infant

    24 hours

Secondary Outcomes (5)

  • Total time of oxytocin use

    24 hours

  • Cesarean delivery

    12 months

  • Blood transfusion

    12 months

  • Neonatal intensive care unit (NICU) admission

    12 months

  • Apgar score at 5 minutes less than 7

    5 minutes after birth

Other Outcomes (1)

  • Cost of hospitalization

    12 months

Study Arms (2)

Treatment

EXPERIMENTAL

Patients for IOL with intracervical balloon placed in the outpatient clinic and sent home

Other: Treatment

Control

NO INTERVENTION

Patients for IOL admitted to Labor and Delivery

Interventions

TreatmentOTHER

Patients for IOL are sent home after placement of intracervical balloon

Treatment

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsNot self described; by virtue of pregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nulliparous women \>18 years of age
  • Singleton live pregnancy
  • Vertex presentation
  • Scheduled induction of labor between 37 and 42 weeks gestation
  • Bishop score \<6

You may not qualify if:

  • Regular painful contractions (\> every 5 minutes)
  • Oligohydramnios or anhydramnios
  • Breech presentation
  • Rupture of membranes
  • Fetal heart tracing with minimal variability or significant decelerations with \>50% contractions
  • Prior vaginal or cesarean delivery
  • Contraindication to vaginal delivery (including placenta previa, morbidly adherent placenta, active genital herpes)
  • Known or suspected placental abruption
  • Major fetal anomaly
  • Poorly controlled hypertension (using 2 or more medications; newly diagnosed preeclampsia; preeclampsia with severe features; superimposed preeclampsia)
  • Poorly controlled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

Related Publications (6)

  • Society of Maternal-Fetal (SMFM) Publications Committee. Electronic address: pubs@smfm.org. SMFM Statement on Elective Induction of Labor in Low-Risk Nulliparous Women at Term: the ARRIVE Trial. Am J Obstet Gynecol. 2019 Jul;221(1):B2-B4. doi: 10.1016/j.ajog.2018.08.009. Epub 2018 Aug 9.

    PMID: 30098985RESULT

  • Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG. 2018 Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10.

    PMID: 29211328RESULT

  • 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.

    PMID: 11704164RESULT

  • Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007372. doi: 10.1002/14651858.CD007372.pub3.

    PMID: 24222365RESULT

  • Main EK. Leading Change on Labor and Delivery: Reducing Nulliparous Term Singleton Vertex (NTSV) Cesarean Rates. Jt Comm J Qual Patient Saf. 2017 Feb;43(2):51-52. doi: 10.1016/j.jcjq.2016.11.009. Epub 2016 Nov 15. No abstract available.

    PMID: 28334562RESULT

  • Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.

    PMID: 32852803DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Herman L Hedriana, MD

    University of California Davis Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparing the duration from admission to delivery in nulliparous women between outpatient cervical ripening and those who were admitted for induction of labor
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2019

First Posted

May 2, 2019

Study Start

December 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2022

Last Updated

April 5, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)