Back to resultsInduction to Labour With Double Cervical Ballon at Home Versus at Hospital (INDOBAMHOS)
Primary Purpose
Induced; Birth, Cervical Dilatation, Live Birth
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cervical rippening at home
Cervical rippening in the hospital
Sponsored by
About this trial
This is an interventional treatment trial for Induced; Birth
Eligibility Criteria
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
Sites / Locations
- Hospital de la Santa Creu i Sant PauRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
At home patients group
Hospitalized patients group
Arm 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.
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.
Outcomes
Primary Outcome Measures
Type of delivery
Vaginal birth, Cesarean section
Secondary Outcome Measures
Parity
Number of pregnancies and deliveries of each patient
Indication of induction
Cathegorical variable, it will be studied the different reason that motivated the induction to delivery for each patient
Weeks of gestation
Measured in number of weeks and days
Bishop score
Score obtained when evaluating the different features of the uterine cervix by touch
Time of dilatation
Hours
Time of cervical rippening balloon
Hours
Partian emptying of the balloon due to pain
Milliliters
Pharmacological analgesia during the cervical rippening
Number of drugs administered
Adverse outcomes
Number of adverse outcomes
Artificial Amniorrhexis
Presence or absence
Oxytocin infusion
Presence or absence
Subsequent PGE2 use
Presence or absence
Hyperstimulation
Presence or absence
Type of delivery
Cathegorical variable, it will be studied the different type of delivery for each patient
Time to delivery
Hours
Reason for instrumentation
Cathegorical variable, it will be studied the different reason of instrumentation
Reason for Cesarean section
Cathegorical variable, it will be studied the different reason of cesarean section
Epidural anesthesia
Presence of absence
Days of postpartum hospitalization
Days
Fever during childbirth
Presence of absence
Perineal injuries
Presence of absence
Postpartum haemorrage
Presence of absence
Anemia
Presence of absence
Uterine rupture
Presence of absence
Maternal ICU admission
Presence of absence
Sepsis
Presence of absence
Meconial amniotic fluid
Presence of absence
Arterial pH
pH value of neonatal umbilical artery
Venous pH
pH value of neonatal umbilical vein
APGAR score
Score obtained when evaluating neonatal apearance, heart rate, muscular tone, activity, breath, gestures
Neonatal Intensive Care Unit (NICU) admission
Days
Neonatal antibiotic administracion
Presence of absence
Neonatal death
Presence of absence
Hypoxic-ischemic encephalopathy
Presence of absence
Neonatal seizures
Presence of absence
Neonatal intubation or chest compressions
Presence of absence
Persistent pulmonary hypertension of the newborn
Presence of absence
Pain/Discomfort
Measure with analogue scale from 1 to 10
Pain/Discomfort
Measure with analogue scale from 1 to 10
Labor Agentry Scale
Score obtained adding different items on the Scale
Edinburg questionnaire for postpartum depression
Score obtained adding different items on the Scale
Impact of Event Scale-Revised
Score obtained adding different items on the Scale
Breastfeeding
Presence of abscence
SF-12 questionnaire
Score obtained adding different items on the Scale
Diagnosis of depression
Presence or Absence
Medical costs
Measured in euros
Full Information
NCT ID
NCT06053073
First Posted
September 6, 2023
Last Updated
September 19, 2023
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT06053073
Brief Title
Induction to Labour With Double Cervical Ballon at Home Versus at Hospital
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Induced; Birth, Cervical Dilatation, Live Birth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
834 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
At home patients group
Arm Type
Experimental
Arm 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.
Arm Title
Hospitalized patients group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Cervical rippening at home
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Cervical rippening in the hospital
Intervention Description
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
Primary Outcome Measure Information:
Title
Type of delivery
Description
Vaginal birth, Cesarean section
Time Frame
End of the delivery
Secondary Outcome Measure Information:
Title
Parity
Description
Number of pregnancies and deliveries of each patient
Time Frame
At time of recruitment and end of delivery, about 1 or 2 days
Title
Indication of induction
Description
Cathegorical variable, it will be studied the different reason that motivated the induction to delivery for each patient
Time Frame
1 day
Title
Weeks of gestation
Description
Measured in number of weeks and days
Time Frame
Only at time of recruitment, 1 day
Title
Bishop score
Description
Score obtained when evaluating the different features of the uterine cervix by touch
Time Frame
Before inserting the rippening balloon and after removing it, about 6 hours
Title
Time of dilatation
Description
Hours
Time Frame
During labour and until delivery, between 1 and 3 days
Title
Time of cervical rippening balloon
Description
Hours
Time Frame
At the insertion of the rippening balloon and after removing it, about 6 hours
Title
Partian emptying of the balloon due to pain
Description
Milliliters
Time Frame
During cervical rippening, about 6 hours
Title
Pharmacological analgesia during the cervical rippening
Description
Number of drugs administered
Time Frame
During cervical rippening, about 6 hours
Title
Adverse outcomes
Description
Number of adverse outcomes
Time Frame
During cervical rippening and labor, between 6 hours and 3 days
Title
Artificial Amniorrhexis
Description
Presence or absence
Time Frame
During cervical rippening and labor, between 6 hours and 3 days
Title
Oxytocin infusion
Description
Presence or absence
Time Frame
During cervical rippening and labor, between 6 hours and 3 days
Title
Subsequent PGE2 use
Description
Presence or absence
Time Frame
During cervical rippening and labor, between 6 hours and 3 days
Title
Hyperstimulation
Description
Presence or absence
Time Frame
During cervical rippening and labor, between 6 hours and 3 days
Title
Type of delivery
Description
Cathegorical variable, it will be studied the different type of delivery for each patient
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Time to delivery
Description
Hours
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Reason for instrumentation
Description
Cathegorical variable, it will be studied the different reason of instrumentation
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Reason for Cesarean section
Description
Cathegorical variable, it will be studied the different reason of cesarean section
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Epidural anesthesia
Description
Presence of absence
Time Frame
During cervical rippening and labor, between 6 hours and 3 days
Title
Days of postpartum hospitalization
Description
Days
Time Frame
From the delivery to discharge from hospital, between 1 and 7 days
Title
Fever during childbirth
Description
Presence of absence
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Perineal injuries
Description
Presence of absence
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Postpartum haemorrage
Description
Presence of absence
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Anemia
Description
Presence of absence
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Uterine rupture
Description
Presence of absence
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Maternal ICU admission
Description
Presence of absence
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Sepsis
Description
Presence of absence
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Meconial amniotic fluid
Description
Presence of absence
Time Frame
During cervical rippening and labor, between 6 hours and 3 days
Title
Arterial pH
Description
pH value of neonatal umbilical artery
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Venous pH
Description
pH value of neonatal umbilical vein
Time Frame
At the moment of the delivery, between 1 day and 3
Title
APGAR score
Description
Score obtained when evaluating neonatal apearance, heart rate, muscular tone, activity, breath, gestures
Time Frame
At the moment of the delivery, between 1 day and 3
Title
Neonatal Intensive Care Unit (NICU) admission
Description
Days
Time Frame
From the delivery to discharge from hospital, between 1 and 7 days
Title
Neonatal antibiotic administracion
Description
Presence of absence
Time Frame
From the delivery to discharge from hospital, between 1 and 7 days
Title
Neonatal death
Description
Presence of absence
Time Frame
From the delivery to discharge from hospital, between 1 and 7 days
Title
Hypoxic-ischemic encephalopathy
Description
Presence of absence
Time Frame
From the delivery to discharge from hospital, between 1 and 7 days
Title
Neonatal seizures
Description
Presence of absence
Time Frame
From the delivery to discharge from hospital, between 1 and 7 days
Title
Neonatal intubation or chest compressions
Description
Presence of absence
Time Frame
From the delivery to discharge from hospital, between 1 and 7 days
Title
Persistent pulmonary hypertension of the newborn
Description
Presence of absence
Time Frame
From the delivery to discharge from hospital, between 1 and 7 days
Title
Pain/Discomfort
Description
Measure with analogue scale from 1 to 10
Time Frame
During insertion of the cervical balloon, between 1 and 3 minutes
Title
Pain/Discomfort
Description
Measure with analogue scale from 1 to 10
Time Frame
During cervical rippening, about 6 hours
Title
Labor Agentry Scale
Description
Score obtained adding different items on the Scale
Time Frame
Up to two months
Title
Edinburg questionnaire for postpartum depression
Description
Score obtained adding different items on the Scale
Time Frame
Up to two months
Title
Impact of Event Scale-Revised
Description
Score obtained adding different items on the Scale
Time Frame
Up to two months
Title
Breastfeeding
Description
Presence of abscence
Time Frame
Up to two months
Title
SF-12 questionnaire
Description
Score obtained adding different items on the Scale
Time Frame
Up to two months
Title
Diagnosis of depression
Description
Presence or Absence
Time Frame
Up to two months
Title
Medical costs
Description
Measured in euros
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Maternal age
Description
Years
Time Frame
At time of recruitment and end of delivery, about 1 or 2 days
Title
Ethnicity
Description
Cathegorical variable, it will be studied the different ethnicities of the patients
Time Frame
At time of recruitment and end of delivery, about 1 or 2 days
Title
Language spoken at home
Description
Cathegorical variable, it will be studied the different ethnicities of the patients
Time Frame
At time of recruitment and end of delivery, about 1 or 2 days
Title
Socioeconomic data
Description
Number of people in the home, type of dwelling, socio-professional category, level of education
Time Frame
At time of recruitment and end of delivery, about 1 or 2 days
Title
Height and weight
Description
Measured in centimeters and kilograms, combined in Body Mass Index
Time Frame
At time of recruitment and end of delivery, about 1 or 2 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria del Carmen Medina Mallén
Phone
0034646337446
Email
mmedinam@santpau.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Ignacio Montoro Pacha
Phone
0034697596106
Email
imontorop@santpau.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa Llurba Olivé
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria del Carmen Medina Mallén
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anna Mundó Fornell
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ignacio Montoro Pacha
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bruna Miarons Ferré
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mitsury Flores
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Montoro Pacha, Resident
Phone
+34697596106
Email
imontorop@santpau.cat
First Name & Middle Initial & Last Name & Degree
Ignacio Montoro Pacha, Resident
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26719596
Citation
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.
Results Reference
background
Learn more about this trial
Induction to Labour With Double Cervical Ballon at Home Versus at Hospital
We'll reach out to this number within 24 hrs