NCT06053073

Brief Summary

The goal of this clinical trial\] is to compare the outcomes between induction to labour at home versus hospitalized. The main questions it aims to answer are:

  • Can the induction to labour at home with cervical rippening ballon increase the vaginal delivery rate?
  • Will the induction to labour at home increase maternal satisfaction
  • Will the induction to labour at home improve medical circuits and coulb it be cost effective? Participants who meet inclusion criteria will undergo randomization so as to be asignated an induction to labour at home or in the hospital. Researchers will compare both labour induction groups to see if the induction to labour at home has better outcomes as described previously.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
834

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

September 6, 2023

Last Update Submit

September 19, 2023

Conditions

Induced; BirthCervical DilatationLive Birth

Outcome Measures

Primary Outcomes (1)

  • Type of delivery

    Vaginal birth, Cesarean section

    End of the delivery

Secondary Outcomes (46)

  • Parity

    At time of recruitment and end of delivery, about 1 or 2 days

  • Indication of induction

    1 day

  • Weeks of gestation

    Only at time of recruitment, 1 day

  • Bishop score

    Before inserting the rippening balloon and after removing it, about 6 hours

  • Time of dilatation

    During labour and until delivery, between 1 and 3 days

  • +41 more secondary outcomes

Other Outcomes (5)

  • Maternal age

    At time of recruitment and end of delivery, about 1 or 2 days

  • Ethnicity

    At time of recruitment and end of delivery, about 1 or 2 days

  • Language spoken at home

    At time of recruitment and end of delivery, about 1 or 2 days

  • +2 more other outcomes

Study Arms (2)

At home patients group

EXPERIMENTAL

After insertion of the Cervical Rippening Balloon and checking fetal and maternal well-being, the patient will go home between 6 and 8 hours to complete the cervical rippening process. The patient will remove autonomously the balloon and will go to the hospital one hour later, where the induction will continue.

Device: Cervical rippening at home

Hospitalized patients group

ACTIVE COMPARATOR

After the insertion of the Cervical Rippening Balloon and verifications of the fetal and materna well-being, the patient will undergo the cervical rippening process for between 6 and 8 hours in the hospital and will remain hospitalized until the time of the delivery.

Device: Cervical rippening in the hospital

Interventions

Cervical rippening at homeDEVICE

The experimental arm of the study will undergo cervical rippening at home between 6 and 8 hours and then will come back to the hospital to continue with the labor induction

At home patients group
Cervical rippening in the hospitalDEVICE

The active comparator arm of the study will undergo cervical rippening in the hospital between 6 and 8 hours and then will remain there to continue with the labor induction

Hospitalized patients group

Eligibility Criteria

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

You may qualify if:

  • Pregnant women with ages \>18 y.o
  • Being able to read and understand the informed consent
  • Accept to join the study when signing the informed consent
  • Singleton
  • Cephalic presentation
  • Weeks of gestation between equal or more than 37 and less than 42
  • Low risk indication of labor induction: Cronologically prolonged gestation
  • Intermediate risk indication of labor induction: Macrosoma, Elevated maternal age, Intrahepatic Gestacional Colestasis, Gestational Diabetes Mellitus treated with diet, Gestational Diabetes Mellitus with insulin therapy and correct metabollic controls, Small for gestacional age fetus, Stable chronic hypertension, anterior caesarean section

You may not qualify if:

  • Premature rupture of membranes (PROM)
  • Breech presentation
  • Unstable presentation
  • Polihydramnios
  • Severe congenital fetal afection
  • Fetal growth restriction
  • Suspected fetal well-being loss on CTG
  • Bishop score equal or higher than seven before insertion of the CRB
  • High cephalic presentation
  • Home further than 30min from Hospital
  • Preeclampsia
  • Diabetes Mellitus type 1
  • Maternal Hypertension
  • Other maternal pathology with severe compromise
  • Oclusive and non-occlusive placenta previa (marginal or low insertion)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Related Publications (1)

  • Rath W, Kehl S. The Renaissance of Transcervical Balloon Catheters for Cervical Ripening and Labour Induction. Geburtshilfe Frauenheilkd. 2015 Nov;75(11):1130-1139. doi: 10.1055/s-0035-1558094.

    PMID: 26719596BACKGROUND

Study Officials

  • Elisa Llurba Olivé

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

  • Maria del Carmen Medina Mallén

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    STUDY DIRECTOR

  • Anna Mundó Fornell

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    STUDY CHAIR

  • Ignacio Montoro Pacha

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    STUDY CHAIR

  • Bruna Miarons Ferré

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    STUDY CHAIR

  • Mitsury Flores

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    STUDY CHAIR

Central Study Contacts

Maria del Carmen Medina Mallén

CONTACT

0034646337446mmedinam@santpau.cat

Ignacio Montoro Pacha

CONTACT

0034697596106imontorop@santpau.cat

Study Design

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

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 25, 2023

Study Start

March 27, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)