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Trial · Interventional

CompletedNot applicableResults postedRegistry data

A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor

NCTNCT02566005 (opens ClinicalTrials.gov in a new tab)Other id15-0032
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Oxytocin, does not test it. It appears in the summary.

Overview

Status
Completed
Phase
Not applicable
Enrollment
200 participants (actual)
Sponsor
St. Luke's-Roosevelt Hospital Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Sept 2015
Primary completion
Jul 2016
Completion
Jul 2016
First posted
1 Oct 2015 (estimated)
Last update posted
27 Mar 2018
Conditions
Pregnancy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. N/A

    A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor

    NCT02566005

    Sept 2015 to Jul 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • misoprostolDevice
  • Foley bulbDevice

Arms2

  • Active comparator

    misoprostol group

    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

  • Active comparator

    misoprostol and foley bulb group

    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.

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. The Time Interval From Induction to Delivery: All Participants

    Time frame · Day 1

    Registry description

    During labor from the start of the induction to the delivery

  2. Time (Hours) From Induction to Delivery: Nulliparous

    Time frame · Day 1

  3. Time (Hours) From Induction to Delivery: Multiparous

    Time frame · Day 1

  4. Time From Induction to Delivery: VD

    Time frame · Day 1

    Registry description

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

  5. Time From Induction to Delivery: CD

    Time frame · Day 1

    Registry description

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

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

    Time frame · day 1

Secondary outcomes(6)

  1. The Time From Induction Until to Active Phase Labor

    Time frame · Day 1

  2. The Time From Active Phase to Delivery

    Time frame · Day 1

  3. Incidence of Chorioamnionitis

    Time frame · Day 1

  4. Incidence of Uterine Tachysystole

    Time frame · Day 1

  5. Incidence of Patient Discomfort

    Time frame · Day 1

  6. Estimated Blood Loss

    Time frame · Day 1

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Day 1

The Time Interval From Induction to Delivery: All Participants

GroupValue (hours)Spread
Misoprostol Group20.9710.27
Misoprostol and Foley Bulb Group16.277.6
Primary outcomeMean· Day 1

Time (Hours) From Induction to Delivery: Nulliparous

GroupValue (hours)Spread
Misoprostol Group22.710.58
Misoprostol and Foley Bulb Group18.157.87
Primary outcomeMean· Day 1

Time (Hours) From Induction to Delivery: Multiparous

GroupValue (hours)Spread
Misoprostol Group15.997.4
Misoprostol and Foley Bulb Group11.894.6
Primary outcomeMean· Day 1

Time From Induction to Delivery: VD

GroupValue (hours)Spread
Misoprostol Group18.878
Misoprostol and Foley Bulb Group15.556.7
Primary outcomeMean· Day 1

Time From Induction to Delivery: CD

GroupValue (hours)Spread
Misoprostol Group24.3812.49
Misoprostol and Foley Bulb Group17.959.29
Primary outcomeMean· day 1

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

GroupValue (hours)Spread
Misoprostol Group20.510910.09
Misoprostol and Foley Bulb Group16.68147.47
Secondary and other outcome results(2)
Secondary outcomeMean· Day 1

The Time From Induction Until to Active Phase Labor

GroupValue (hours)Spread
Misoprostol Group17.438.6
Misoprostol and Foley Bulb Group12.815.83
Secondary outcomeMean· Day 1

The Time From Active Phase to Delivery

GroupValue (hours)Spread
Misoprostol Group3.112.75
Misoprostol and Foley Bulb Group3.763

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Misoprostol Group25mcg 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.)0 / 1000 / 1000 / 100
Misoprostol and Foley Bulb Group25mcg of misoprostol per vagina every 4hours per the standard hospital 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.0 / 1000 / 1000 / 100

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Systematic review · 2023

Mechanical methods for induction of labour.

de Vaan et al. 2023The Cochrane database of systematic reviewscited by 38

PMID 36996264PMC10061553DOI 10.1002/14651858.cd001233.pub4PUB-36996264

Free to read · publisher termsCC BY-NC
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedAl-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 29215514

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria * Term 37 weeks or more, singleton in cephalic presentation * Age 18 years and older * Patient admitted for induction of labor Exclusion Criteria: * 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

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