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

Induction to Labour With Double Cervical Ballon at Home Versus at Hospital to Improve the Vaginal Delivery Rate, Maternal Satisfaction and Reduce Costs: Multicentric Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Induced; Birth; Live Birth; Cervical Dilatation
• Intervention / Treatment: Device: Cervical rippening at home; Device: Cervical rippening in the hospital

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 834
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria del Carmen Medina Mallén; Phone Number: 0034646337446; Email: mmedinam@santpau.cat
• Study Contact Backup: Name: Ignacio Montoro Pacha; Phone Number: 0034697596106; Email: imontorop@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Ignacio Montoro Pacha, Resident; Phone Number: +34697596106; Email: imontorop@santpau.cat
    • Sub-Investigator: Ignacio Montoro Pacha, Resident

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: At home patients group; 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; 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
Active Comparator: Hospitalized patients group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of delivery	Vaginal birth, Cesarean section	End of the delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parity	Number of pregnancies and deliveries of each patient	At time of recruitment and end of delivery, about 1 or 2 days
Indication of induction	Cathegorical variable, it will be studied the different reason that motivated the induction to delivery for each patient	1 day
Weeks of gestation	Measured in number of weeks and days	Only at time of recruitment, 1 day
Bishop score	Score obtained when evaluating the different features of the uterine cervix by touch	Before inserting the rippening balloon and after removing it, about 6 hours
Time of dilatation	Hours	During labour and until delivery, between 1 and 3 days
Time of cervical rippening balloon	Hours	At the insertion of the rippening balloon and after removing it, about 6 hours
Partian emptying of the balloon due to pain	Milliliters	During cervical rippening, about 6 hours
Pharmacological analgesia during the cervical rippening	Number of drugs administered	During cervical rippening, about 6 hours
Adverse outcomes	Number of adverse outcomes	During cervical rippening and labor, between 6 hours and 3 days
Artificial Amniorrhexis	Presence or absence	During cervical rippening and labor, between 6 hours and 3 days
Oxytocin infusion	Presence or absence	During cervical rippening and labor, between 6 hours and 3 days
Subsequent PGE2 use	Presence or absence	During cervical rippening and labor, between 6 hours and 3 days
Hyperstimulation	Presence or absence	During cervical rippening and labor, between 6 hours and 3 days
Type of delivery	Cathegorical variable, it will be studied the different type of delivery for each patient	At the moment of the delivery, between 1 day and 3
Time to delivery	Hours	At the moment of the delivery, between 1 day and 3
Reason for instrumentation	Cathegorical variable, it will be studied the different reason of instrumentation	At the moment of the delivery, between 1 day and 3
Reason for Cesarean section	Cathegorical variable, it will be studied the different reason of cesarean section	At the moment of the delivery, between 1 day and 3
Epidural anesthesia	Presence of absence	During cervical rippening and labor, between 6 hours and 3 days
Days of postpartum hospitalization	Days	From the delivery to discharge from hospital, between 1 and 7 days
Fever during childbirth	Presence of absence	At the moment of the delivery, between 1 day and 3
Perineal injuries	Presence of absence	At the moment of the delivery, between 1 day and 3
Postpartum haemorrage	Presence of absence	At the moment of the delivery, between 1 day and 3
Anemia	Presence of absence	At the moment of the delivery, between 1 day and 3
Uterine rupture	Presence of absence	At the moment of the delivery, between 1 day and 3
Maternal ICU admission	Presence of absence	At the moment of the delivery, between 1 day and 3
Sepsis	Presence of absence	At the moment of the delivery, between 1 day and 3
Meconial amniotic fluid	Presence of absence	During cervical rippening and labor, between 6 hours and 3 days
Arterial pH	pH value of neonatal umbilical artery	At the moment of the delivery, between 1 day and 3
Venous pH	pH value of neonatal umbilical vein	At the moment of the delivery, between 1 day and 3
APGAR score	Score obtained when evaluating neonatal apearance, heart rate, muscular tone, activity, breath, gestures	At the moment of the delivery, between 1 day and 3
Neonatal Intensive Care Unit (NICU) admission	Days	From the delivery to discharge from hospital, between 1 and 7 days
Neonatal antibiotic administracion	Presence of absence	From the delivery to discharge from hospital, between 1 and 7 days
Neonatal death	Presence of absence	From the delivery to discharge from hospital, between 1 and 7 days
Hypoxic-ischemic encephalopathy	Presence of absence	From the delivery to discharge from hospital, between 1 and 7 days
Neonatal seizures	Presence of absence	From the delivery to discharge from hospital, between 1 and 7 days
Neonatal intubation or chest compressions	Presence of absence	From the delivery to discharge from hospital, between 1 and 7 days
Persistent pulmonary hypertension of the newborn	Presence of absence	From the delivery to discharge from hospital, between 1 and 7 days
Pain/Discomfort	Measure with analogue scale from 1 to 10	During insertion of the cervical balloon, between 1 and 3 minutes
Pain/Discomfort	Measure with analogue scale from 1 to 10	During cervical rippening, about 6 hours
Labor Agentry Scale	Score obtained adding different items on the Scale	Up to two months
Edinburg questionnaire for postpartum depression	Score obtained adding different items on the Scale	Up to two months
Impact of Event Scale-Revised	Score obtained adding different items on the Scale	Up to two months
Breastfeeding	Presence of abscence	Up to two months
SF-12 questionnaire	Score obtained adding different items on the Scale	Up to two months
Diagnosis of depression	Presence or Absence	Up to two months
Medical costs	Measured in euros	One year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal age	Years	At time of recruitment and end of delivery, about 1 or 2 days
Ethnicity	Cathegorical variable, it will be studied the different ethnicities of the patients	At time of recruitment and end of delivery, about 1 or 2 days
Language spoken at home	Cathegorical variable, it will be studied the different ethnicities of the patients	At time of recruitment and end of delivery, about 1 or 2 days
Socioeconomic data	Number of people in the home, type of dwelling, socio-professional category, level of education	At time of recruitment and end of delivery, about 1 or 2 days
Height and weight	Measured in centimeters and kilograms, combined in Body Mass Index	At time of recruitment and end of delivery, about 1 or 2 days

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Elisa Llurba Olivé, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Study Director: Maria del Carmen Medina Mallén, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Study Chair: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: IIBSP-DBC-2021-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes