Induced; BirthINDOBAMHOSNCT06053073
Induction to Labour With Double Cervical Ballon at Home Versus at Hospital
A study testing Cervical rippening at home and Cervical rippening in the hospital in people with Induced; Birth and Cervical Dilatation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced; Birth, Cervical Dilatation, Live Birth
- What is being tested?
- Cervical rippening at home and Cervical rippening in the hospital
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 834 participants
- Where
- 1 siteSpain
- Study dates
- 27 Mar 2023to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Premature rupture of membranes (PROM)
- Breech presentation
- Unstable presentation
- Polihydramnios
- Severe congenital fetal afection
- Fetal growth restriction
Show all 23Show fewer
- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Ignacio Montoro Pacha, Resident, +34697596106, imontorop@santpau.cat
Ignacio Montoro Pacha, Resident
About this study
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
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.
Read the 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.
- Conditions
- Induced; Birth, Cervical Dilatation, Live Birth
- Being tested
- Cervical rippening at home, Cervical rippening in the hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Cervical rippening in the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of delivery
Vaginal birth, Cesarean section
Measured: End of the delivery
Secondary outcomes (46)
Parity
Number of pregnancies and deliveries of each patient
Measured: 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
Measured: 1 day
Weeks of gestation
Measured in number of weeks and days
Measured: Only at time of recruitment, 1 day
Bishop score
Score obtained when evaluating the different features of the uterine cervix by touch
Measured: Before inserting the rippening balloon and after removing it, about 6 hours
Time of dilatation
Hours
Measured: During labour and until delivery, between 1 and 3 days
Time of cervical rippening balloon
Hours
Measured: At the insertion of the rippening balloon and after removing it, about 6 hours
Partian emptying of the balloon due to pain
Milliliters
Measured: During cervical rippening, about 6 hours
Pharmacological analgesia during the cervical rippening
Number of drugs administered
Measured: During cervical rippening, about 6 hours
Adverse outcomes
Number of adverse outcomes
Measured: During cervical rippening and labor, between 6 hours and 3 days
Artificial Amniorrhexis
Presence or absence
Measured: During cervical rippening and labor, between 6 hours and 3 days
Oxytocin infusion
Presence or absence
Measured: During cervical rippening and labor, between 6 hours and 3 days
Subsequent PGE2 use
Presence or absence
Measured: During cervical rippening and labor, between 6 hours and 3 days
Hyperstimulation
Presence or absence
Measured: 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
Measured: At the moment of the delivery, between 1 day and 3
Time to delivery
Hours
Measured: 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
Measured: 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
Measured: At the moment of the delivery, between 1 day and 3
Epidural anesthesia
Presence of absence
Measured: During cervical rippening and labor, between 6 hours and 3 days
Days of postpartum hospitalization
Days
Measured: From the delivery to discharge from hospital, between 1 and 7 days
Fever during childbirth
Presence of absence
Measured: At the moment of the delivery, between 1 day and 3
Perineal injuries
Presence of absence
Measured: At the moment of the delivery, between 1 day and 3
Postpartum haemorrage
Presence of absence
Measured: At the moment of the delivery, between 1 day and 3
Anemia
Presence of absence
Measured: At the moment of the delivery, between 1 day and 3
Uterine rupture
Presence of absence
Measured: At the moment of the delivery, between 1 day and 3
Maternal ICU admission
Presence of absence
Measured: At the moment of the delivery, between 1 day and 3
Sepsis
Presence of absence
Measured: At the moment of the delivery, between 1 day and 3
Meconial amniotic fluid
Presence of absence
Measured: During cervical rippening and labor, between 6 hours and 3 days
Arterial pH
pH value of neonatal umbilical artery
Measured: At the moment of the delivery, between 1 day and 3
Venous pH
pH value of neonatal umbilical vein
Measured: 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
Measured: At the moment of the delivery, between 1 day and 3
Neonatal Intensive Care Unit (NICU) admission
Days
Measured: From the delivery to discharge from hospital, between 1 and 7 days
Neonatal antibiotic administracion
Presence of absence
Measured: From the delivery to discharge from hospital, between 1 and 7 days
Neonatal death
Presence of absence
Measured: From the delivery to discharge from hospital, between 1 and 7 days
Hypoxic-ischemic encephalopathy
Presence of absence
Measured: From the delivery to discharge from hospital, between 1 and 7 days
Neonatal seizures
Presence of absence
Measured: From the delivery to discharge from hospital, between 1 and 7 days
Neonatal intubation or chest compressions
Presence of absence
Measured: From the delivery to discharge from hospital, between 1 and 7 days
Persistent pulmonary hypertension of the newborn
Presence of absence
Measured: From the delivery to discharge from hospital, between 1 and 7 days
Pain/Discomfort
Measure with analogue scale from 1 to 10
Measured: During insertion of the cervical balloon, between 1 and 3 minutes
Pain/Discomfort
Measure with analogue scale from 1 to 10
Measured: During cervical rippening, about 6 hours
Labor Agentry Scale
Score obtained adding different items on the Scale
Measured: Up to two months
Edinburg questionnaire for postpartum depression
Score obtained adding different items on the Scale
Measured: Up to two months
Impact of Event Scale-Revised
Score obtained adding different items on the Scale
Measured: Up to two months
Breastfeeding
Presence of abscence
Measured: Up to two months
SF-12 questionnaire
Score obtained adding different items on the Scale
Measured: Up to two months
Diagnosis of depression
Presence or Absence
Measured: Up to two months
Medical costs
Measured in euros
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start27 Mar 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induced; BirthStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 834 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Llurba Olivé, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauMaria del Carmen Medina Mallén, Study director, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauAnna Mundó Fornell, Study chair, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauIgnacio Montoro Pacha, Study chair, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauBruna Miarons Ferré, Study chair, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauMitsury Flores, Study chair, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053073
- Sponsor's protocol ID
- IIBSP-DBC-2021-35
- Acronym
- INDOBAMHOS
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 26719596
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06053073
- Acronym / sponsor ID
- INDOBAMHOS / IIBSP-DBC-2021-35
- Conditions
- Induced; Birth, Cervical Dilatation, Live Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 834 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At home patients group | Experimental | Device: Cervical rippening at homeAfter 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. |
| Hospitalized patients group | Active comparator | Device: Cervical rippening in the hospitalAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- Premature rupture of membranes (PROM)
- Breech presentation
- Unstable presentation
- Polihydramnios
- Severe congenital fetal afection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical rippening at homeThe 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 | Device | At home patients group |
| Cervical rippening in the hospitalThe 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 | Device | Hospitalized patients group |
Primary outcome
Type of delivery
Time frame: End of the delivery
Vaginal birth, Cesarean section
46 secondary outcomes
Parity
Time frame: At time of recruitment and end of delivery, about 1 or 2 days
Indication of induction
Time frame: 1 day
Weeks of gestation
Time frame: Only at time of recruitment, 1 day
Bishop score
Time frame: Before inserting the rippening balloon and after removing it, about 6 hours
Time of dilatation
Time frame: During labour and until delivery, between 1 and 3 days
Time of cervical rippening balloon
Time frame: At the insertion of the rippening balloon and after removing it, about 6 hours
Partian emptying of the balloon due to pain
Time frame: During cervical rippening, about 6 hours
Pharmacological analgesia during the cervical rippening
Time frame: During cervical rippening, about 6 hours
Adverse outcomes
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Artificial Amniorrhexis
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Oxytocin infusion
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Subsequent PGE2 use
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Hyperstimulation
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Type of delivery
Time frame: At the moment of the delivery, between 1 day and 3
Time to delivery
Time frame: At the moment of the delivery, between 1 day and 3
Reason for instrumentation
Time frame: At the moment of the delivery, between 1 day and 3
Reason for Cesarean section
Time frame: At the moment of the delivery, between 1 day and 3
Epidural anesthesia
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Days of postpartum hospitalization
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Fever during childbirth
Time frame: At the moment of the delivery, between 1 day and 3
Perineal injuries
Time frame: At the moment of the delivery, between 1 day and 3
Postpartum haemorrage
Time frame: At the moment of the delivery, between 1 day and 3
Anemia
Time frame: At the moment of the delivery, between 1 day and 3
Uterine rupture
Time frame: At the moment of the delivery, between 1 day and 3
Maternal ICU admission
Time frame: At the moment of the delivery, between 1 day and 3
Sepsis
Time frame: At the moment of the delivery, between 1 day and 3
Meconial amniotic fluid
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Arterial pH
Time frame: At the moment of the delivery, between 1 day and 3
Venous pH
Time frame: At the moment of the delivery, between 1 day and 3
APGAR score
Time frame: At the moment of the delivery, between 1 day and 3
Neonatal Intensive Care Unit (NICU) admission
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Neonatal antibiotic administracion
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Neonatal death
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Hypoxic-ischemic encephalopathy
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Neonatal seizures
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Neonatal intubation or chest compressions
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Persistent pulmonary hypertension of the newborn
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Pain/Discomfort
Time frame: During insertion of the cervical balloon, between 1 and 3 minutes
Pain/Discomfort
Time frame: During cervical rippening, about 6 hours
Labor Agentry Scale
Time frame: Up to two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Background: PubMed 26719596Rath 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Llurba Olivé principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Maria del Carmen Medina Mallén study director
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Anna Mundó Fornell study chair
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical rippening at home and Cervical rippening in the hospital in people with Induced; Birth and Cervical Dilatation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria del Carmen Medina Mallén (0034646337446, mmedinam@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of delivery (time frame: End of the delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06053073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.