NCT02566005

Brief Summary

A randomized, prospective trial will be offered to women admitted to the Roosevelt Hospital labor floor for labor induction. The hypothesis is that the simultaneous use of a foley bulb together with vaginal misoprostol will result in shorter induction to delivery time compared with vaginal misoprostol alone

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 27, 2018

Completed
Last Updated

March 27, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

September 30, 2015

Results QC Date

February 2, 2018

Last Update Submit

February 26, 2018

Conditions

Pregnancy

Keywords

MisoprostolInductionFoley

Outcome Measures

Primary Outcomes (6)

  • The Time Interval From Induction to Delivery: All Participants

    During labor from the start of the induction to the delivery

    Day 1

  • Time (Hours) From Induction to Delivery: Nulliparous

    Day 1

  • Time (Hours) From Induction to Delivery: Multiparous

    Day 1

  • Time From Induction to Delivery: VD

    Time (hours) from induction to delivery: Vaginal Delivery (VD)

    Day 1

  • Time From Induction to Delivery: CD

    Time (hours) from induction to delivery: Cesarean Delivery (CD)

    Day 1

  • Per Treatment Protocol: Time (Hours) From Induction to Delivery

    day 1

Secondary Outcomes (6)

  • The Time From Induction Until to Active Phase Labor

    Day 1

  • The Time From Active Phase to Delivery

    Day 1

  • Incidence of Chorioamnionitis

    Day 1

  • Incidence of Uterine Tachysystole

    Day 1

  • Incidence of Patient Discomfort

    Day 1

  • +1 more secondary outcomes

Study Arms (2)

misoprostol group

ACTIVE COMPARATOR

The women in the misoprostol only group will receive 25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist

Device: misoprostol

misoprostol and foley bulb group

ACTIVE COMPARATOR

Women in the combination group will receive vaginal misoprostol per standard protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient's inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.

Device: misoprostolDevice: Foley bulb

Interventions

misoprostolDEVICE

25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist).

Also known as: cytotec
misoprostol and foley bulb groupmisoprostol group
Foley bulbDEVICE

a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient's inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours.

Also known as: foley bulb (ballon)
misoprostol and foley bulb group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Term 37 weeks or more, singleton in cephalic presentation
  • Age 18 years and older
  • Patient admitted for induction of labor

You may not qualify if:

  • Malpresentation
  • Preterm labor less than 37 weeks of gestation
  • Patients with fetal anomalies
  • Premature rupture of membranes
  • If the cervix is closed and unable to place the foley bulb
  • Multiple gestation
  • Non-reassuring fetal heart tracing
  • Contraindication to misoprostol
  • Contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, marginal previa, macrosomia, etc). History of prior uterine surgery such as cesarean section or myomectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Roosevelt

New York, New York, 10019, United States

Location

Related Publications (2)

  • 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

  • Al-Ibraheemi Z, Brustman L, Bimson BE, Porat N, Rosenn B. Misoprostol With Foley Bulb Compared With Misoprostol Alone for Cervical Ripening: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):23-29. doi: 10.1097/AOG.0000000000002403.

    PMID: 29215514DERIVED

Results Point of Contact

Title
Dr. Zainab Al-Ibraheemi
Organization
Mount Sinai Health Systems
Zainab.Al-ibraheemi@mountsinai.org

Study Officials

  • Zainab Al-Ibraheemi, MD

    Mount Sinai St Luke's Roosevelt Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 1, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 27, 2018

Results First Posted

March 27, 2018

Record last verified: 2018-02

Locations

US(1)