NCT02762942

Brief Summary

Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vaginal misoprostol alone.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

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 26, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

April 26, 2016

Last Update Submit

May 11, 2016

Conditions

Induction of LaborCervical RipeningPregnancy

Keywords

cervical ripeningmisoprostolsupracervical balloonFoley catheter

Outcome Measures

Primary Outcomes (1)

  • Induction to delivery time

    1 year

Secondary Outcomes (18)

  • Bishop score at 12 hours from the onset of induction

    1 year

  • Bishop score at 24 hours from the onset of induction

    1 year

  • Number of doses of misoprostol required

    1 year

  • Percentage of pregnant women requiring oxytocin

    1 year

  • Maximum dosage of oxytocin given (mU / min)

    1 year

  • +13 more secondary outcomes

Study Arms (2)

Vaginal misoprostol alone

ACTIVE COMPARATOR

Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol according to local protocols

Drug: Misoprostol

Vaginal misoprostol + Foley catheter

EXPERIMENTAL

Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. At the same time a 16French Foley catheter will be inserted through the internal os with visualization of the cervix by sterile speculum examination. The catheter balloon will be inflated with 30 ml of sterile normal saline solution and then the catheter will be taped with gentle traction to the inner thigh of the patient until spontaneous expulsion. If this does not occur, the catheter will be deflated and removed after 12 hours. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol.

Drug: MisoprostolDevice: Foley catheter

Interventions

MisoprostolDRUG

Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses

Also known as: Misofar
Vaginal misoprostol + Foley catheterVaginal misoprostol alone
Foley catheterDEVICE

Insertion of a Foley catheter (16French) through the internal os for a maximum of 12 hours

Also known as: Supracervical balloon
Vaginal misoprostol + Foley catheter

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton pregnancy
  • Cephalic presentation
  • Reassuring fetal heart rate pattern
  • Intact membranes
  • Bishop score less than 6

You may not qualify if:

  • Severe preeclampsia
  • Prematurity ( \< 37 weeks gestation dated by first trimester ultrasound)
  • Previous cesarean section or previous uterine surgery
  • Intrauterine growth restriction
  • Premature rupture of membranes
  • Maternal colonization with Streptococcus Agalactiae at any time during pregnancy
  • Multifetal pregnancy
  • Breech presentation
  • Stillbirth
  • Any contraindication for vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

RECRUITING

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

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Àngels Vives Argilagós, MD

    Consorci Sanitari de Terrassa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Àngels Vives Argilagós, MD

CONTACT

+34 937310007MAVives@cst.cat

Marino Romero Ramírez, MD

CONTACT

+34 937310007marino.rora@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrician

Study Record Dates

First Submitted

April 26, 2016

First Posted

May 5, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

May 12, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)