Induction to Labour With Double Cervical Ballon at Home Versus at Hospital

Induced; Birth Clinical Trial

— INDOBAMHOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053073
• Other study ID #: IIBSP-DBC-2021-35
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: March 2026

Study information

• Verified date: September 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Maria del Carmen Medina Mallén
• Phone: 0034646337446
• Email: mmedinam[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 834
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dilatation
• Induced; Birth
• Live Birth

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

Outcome

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