Induction to Labour With Double Cervical Ballon at Home Versus at Hospital (INDOBAMHOS)

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

Status: Enrolling

Conditions: Induced; Birth; Live Birth; Cervical Dilatation

Treatments: Device: Cervical rippening in the hospital; Device: Cervical rippening at home

Study type: Interventional

Funder types: Other

Identifiers

NCT06053073

IIBSP-DBC-2021-35

Details and patient eligibility

About

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.

Full description

INDOBAMHOS is a multicentric randomized clinical trial which is based in the principle that cervical rippening with intracervical probes with ballons is as safe as pharmacological induction with PGE2 and it seems to be a suitable option to develop the cervical rippening process of the induction at home rather than in the hospital.

The purpouse of the study is to demonstrate that the comfort of performing the cervical rippenning at home will benefit patients with an increase of the vaginal delivery rate and increases maternal satisfaction. And also will improve medical circuits and could be cost-effective when compared to hospitalized labour induction.

Enrollment: 834 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Vaginal delivery Exclusion:
• Oclusive and non-occlusive placenta previa (marginal or low insertion)
• Vasa previa
• Transverse / Oblique situation
• Cord prolapse
• History of previous caesarean section with uterine incission in inverted T
• History of uterine rupture
• Two or more previous Caesarean section
• Active genital herpetical infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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834 participants in 2 patient groups

At home patients group

Experimental group

Description:

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.

Treatment:

Device: Cervical rippening at home

Hospitalized patients group

Active Comparator group

Description:

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.

Treatment:

Device: Cervical rippening in the hospital