NCT02899689

Brief Summary

Women undergoing mechanical cervical ripening for labor induction will be randomized to Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
419

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

2 active sites

Status
completed

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

August 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

November 18, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2018

Enrollment Period

1.4 years

First QC Date

August 31, 2016

Results QC Date

February 26, 2019

Last Update Submit

October 26, 2020

Conditions

Pre-induction Dilation of Cervix

Keywords

LaborFoleyDilapanCervical DilatorsInduction

Outcome Measures

Primary Outcomes (1)

  • Rate of Vaginal Delivery

    Proportion of patients that delivered vaginal. (%)

    Through study completion, an average of 1-2 years

Secondary Outcomes (5)

  • Time of Vaginal Delivery

    2-4 days

  • Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation

    1-2 days

  • Change in Bishop Scores

    12-24 hrs

  • Operative Deliveries

    1-4 days

  • Cesarean Deliveries

    1-4 days

Other Outcomes (10)

  • Analgesia Requirement

    1-2 days

  • Spontaneous Labor

    1-4 days

  • Pharmacological Agents for Labor Induction (Prostaglandins, Oxytocin)(%)

    1-2 days

  • +7 more other outcomes

Study Arms (2)

Foley Bulb Group

ACTIVE COMPARATOR

Patients will have a Foley catheter inserted into the internal cervical os.

Device: Foley Catheter

Dilapan Group

EXPERIMENTAL

Patients will have Dilapan sticks inserted into the internal cervical os.

Device: Dilapan

Interventions

DilapanDEVICE

Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.

Also known as: Osmotic cervical dilator
Dilapan Group
Foley CatheterDEVICE

Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.

Also known as: Foley Bulb
Foley Bulb Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant woman scheduled for induction of labor.
  • Age between 18 and 45 years.
  • Understanding and capable to sign informed consent.
  • Singleton pregnancy.
  • Gestational age ≥ 37 0/7 weeks.
  • Live fetus in cephalic presentation.
  • Intact membranes.
  • Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced.

You may not qualify if:

  • Iodine allergy.
  • Active labor or oxytocin has been administered.
  • Chorioamnionitis.
  • Prior uterine or cervical surgery.
  • Non reassuring fetal status requiring immediate delivery.
  • Non-cephalic fetal presentation.
  • Active vaginal bleeding from cervical os.
  • Placenta previa.
  • EFW \> 5000 gm(non diabetic) or \> 4500gm (diabetic).
  • Other contraindication to vaginal delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Texas

Galveston, Texas, 77555, United States

Location

UTMB Galveston

Galveston, Texas, 77555, United States

Location

Related Publications (1)

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

Results Point of Contact

Title
Antonio F Saad
Organization
UTMB
afsaad@utmb.edu
4097720982

Study Officials

  • Antonio Saad, MD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 14, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

November 18, 2020

Results First Posted

November 18, 2020

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)