INDOBAMHOS: Induction to Labour With Double Cervical Ballon at Home Versus at Hospital
Study Details
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:
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Can the induction to labour at home with cervical rippening ballon increase the vaginal delivery rate?
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Will the induction to labour at home increase maternal satisfaction
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Type of delivery [End of the delivery]
Vaginal birth, Cesarean section
Secondary Outcome Measures
- Parity [At time of recruitment and end of delivery, about 1 or 2 days]
Number of pregnancies and deliveries of each patient
- Indication of induction [1 day]
Cathegorical variable, it will be studied the different reason that motivated the induction to delivery for each patient
- Weeks of gestation [Only at time of recruitment, 1 day]
Measured in number of weeks and days
- Bishop score [Before inserting the rippening balloon and after removing it, about 6 hours]
Score obtained when evaluating the different features of the uterine cervix by touch
- Time of dilatation [During labour and until delivery, between 1 and 3 days]
Hours
- Time of cervical rippening balloon [At the insertion of the rippening balloon and after removing it, about 6 hours]
Hours
- Partian emptying of the balloon due to pain [During cervical rippening, about 6 hours]
Milliliters
- Pharmacological analgesia during the cervical rippening [During cervical rippening, about 6 hours]
Number of drugs administered
- Adverse outcomes [During cervical rippening and labor, between 6 hours and 3 days]
Number of adverse outcomes
- Artificial Amniorrhexis [During cervical rippening and labor, between 6 hours and 3 days]
Presence or absence
- Oxytocin infusion [During cervical rippening and labor, between 6 hours and 3 days]
Presence or absence
- Subsequent PGE2 use [During cervical rippening and labor, between 6 hours and 3 days]
Presence or absence
- Hyperstimulation [During cervical rippening and labor, between 6 hours and 3 days]
Presence or absence
- Type of delivery [At the moment of the delivery, between 1 day and 3]
Cathegorical variable, it will be studied the different type of delivery for each patient
- Time to delivery [At the moment of the delivery, between 1 day and 3]
Hours
- Reason for instrumentation [At the moment of the delivery, between 1 day and 3]
Cathegorical variable, it will be studied the different reason of instrumentation
- Reason for Cesarean section [At the moment of the delivery, between 1 day and 3]
Cathegorical variable, it will be studied the different reason of cesarean section
- Epidural anesthesia [During cervical rippening and labor, between 6 hours and 3 days]
Presence of absence
- Days of postpartum hospitalization [From the delivery to discharge from hospital, between 1 and 7 days]
Days
- Fever during childbirth [At the moment of the delivery, between 1 day and 3]
Presence of absence
- Perineal injuries [At the moment of the delivery, between 1 day and 3]
Presence of absence
- Postpartum haemorrage [At the moment of the delivery, between 1 day and 3]
Presence of absence
- Anemia [At the moment of the delivery, between 1 day and 3]
Presence of absence
- Uterine rupture [At the moment of the delivery, between 1 day and 3]
Presence of absence
- Maternal ICU admission [At the moment of the delivery, between 1 day and 3]
Presence of absence
- Sepsis [At the moment of the delivery, between 1 day and 3]
Presence of absence
- Meconial amniotic fluid [During cervical rippening and labor, between 6 hours and 3 days]
Presence of absence
- Arterial pH [At the moment of the delivery, between 1 day and 3]
pH value of neonatal umbilical artery
- Venous pH [At the moment of the delivery, between 1 day and 3]
pH value of neonatal umbilical vein
- APGAR score [At the moment of the delivery, between 1 day and 3]
Score obtained when evaluating neonatal apearance, heart rate, muscular tone, activity, breath, gestures
- Neonatal Intensive Care Unit (NICU) admission [From the delivery to discharge from hospital, between 1 and 7 days]
Days
- Neonatal antibiotic administracion [From the delivery to discharge from hospital, between 1 and 7 days]
Presence of absence
- Neonatal death [From the delivery to discharge from hospital, between 1 and 7 days]
Presence of absence
- Hypoxic-ischemic encephalopathy [From the delivery to discharge from hospital, between 1 and 7 days]
Presence of absence
- Neonatal seizures [From the delivery to discharge from hospital, between 1 and 7 days]
Presence of absence
- Neonatal intubation or chest compressions [From the delivery to discharge from hospital, between 1 and 7 days]
Presence of absence
- Persistent pulmonary hypertension of the newborn [From the delivery to discharge from hospital, between 1 and 7 days]
Presence of absence
- Pain/Discomfort [During insertion of the cervical balloon, between 1 and 3 minutes]
Measure with analogue scale from 1 to 10
- Pain/Discomfort [During cervical rippening, about 6 hours]
Measure with analogue scale from 1 to 10
- Labor Agentry Scale [Up to two months]
Score obtained adding different items on the Scale
- Edinburg questionnaire for postpartum depression [Up to two months]
Score obtained adding different items on the Scale
- Impact of Event Scale-Revised [Up to two months]
Score obtained adding different items on the Scale
- Breastfeeding [Up to two months]
Presence of abscence
- SF-12 questionnaire [Up to two months]
Score obtained adding different items on the Scale
- Diagnosis of depression [Up to two months]
Presence or Absence
- Medical costs [One year]
Measured in euros
Other Outcome Measures
- Maternal age [At time of recruitment and end of delivery, about 1 or 2 days]
Years
- Ethnicity [At time of recruitment and end of delivery, about 1 or 2 days]
Cathegorical variable, it will be studied the different ethnicities of the patients
- Language spoken at home [At time of recruitment and end of delivery, about 1 or 2 days]
Cathegorical variable, it will be studied the different ethnicities of the patients
- Socioeconomic data [At time of recruitment and end of delivery, about 1 or 2 days]
Number of people in the home, type of dwelling, socio-professional category, level of education
- Height and weight [At time of recruitment and end of delivery, about 1 or 2 days]
Measured in centimeters and kilograms, combined in Body Mass Index
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pregnant women with ages >18 y.o
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Being able to read and understand the informed consent
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Accept to join the study when signing the informed consent
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Singleton
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Cephalic presentation
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Weeks of gestation between equal or more than 37 and less than 42
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Low risk indication of labor induction: Cronologically prolonged gestation
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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:
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Premature rupture of membranes (PROM)
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Breech presentation
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Unstable presentation
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Polihydramnios
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Severe congenital fetal afection
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Fetal growth restriction
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Suspected fetal well-being loss on CTG
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Bishop score equal or higher than seven before insertion of the CRB
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High cephalic presentation
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Home further than 30min from Hospital
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Preeclampsia
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Diabetes Mellitus type 1
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Maternal Hypertension
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Other maternal pathology with severe compromise
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Vaginal delivery Exclusion:
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Oclusive and non-occlusive placenta previa (marginal or low insertion)
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Vasa previa
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Transverse / Oblique situation
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Cord prolapse
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History of previous caesarean section with uterine incission in inverted T
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History of uterine rupture
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Two or more previous Caesarean section
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Active genital herpetical infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | 08025 |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- IIBSP-DBC-2021-35