Clinical trial NCT06053073: Induction to Labour With Double Cervical Ballon at Home Versus at Hospital
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
Overall status: RECRUITING
Phase: NA
Conditions: Induced; Birth
Cervical Dilatation
Live Birth
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 834
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Type of delivery
timeFrame: End of the delivery
Secondary outcomes:
measure: Parity
timeFrame: At time of recruitment and end of delivery, about 1 or 2 days
measure: Indication of induction
timeFrame: 1 day
measure: Weeks of gestation
timeFrame: Only at time of recruitment, 1 day
measure: Bishop score
timeFrame: Before inserting the rippening balloon and after removing it, about 6 hours
measure: Time of dilatation
timeFrame: During labour and until delivery, between 1 and 3 days
measure: Time of cervical rippening balloon
timeFrame: At the insertion of the rippening balloon and after removing it, about 6 hours
measure: Partian emptying of the balloon due to pain
timeFrame: During cervical rippening, about 6 hours
measure: Pharmacological analgesia during the cervical rippening
timeFrame: During cervical rippening, about 6 hours
measure: Adverse outcomes
timeFrame: During cervical rippening and labor, between 6 hours and 3 days
measure: Artificial Amniorrhexis
timeFrame: During cervical rippening and labor, between 6 hours and 3 days
measure: Oxytocin infusion
timeFrame: During cervical rippening and labor, between 6 hours and 3 days
measure: Subsequent PGE2 use
timeFrame: During cervical rippening and labor, between 6 hours and 3 days
measure: Hyperstimulation
timeFrame: During cervical rippening and labor, between 6 hours and 3 days
measure: Type of delivery
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Time to delivery
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Reason for instrumentation
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Reason for Cesarean section
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Epidural anesthesia
timeFrame: During cervical rippening and labor, between 6 hours and 3 days
measure: Days of postpartum hospitalization
timeFrame: From the delivery to discharge from hospital, between 1 and 7 days
measure: Fever during childbirth
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Perineal injuries
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Postpartum haemorrage
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Anemia
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Uterine rupture
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Maternal ICU admission
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Sepsis
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Meconial amniotic fluid
timeFrame: During cervical rippening and labor, between 6 hours and 3 days
measure: Arterial pH
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Venous pH
timeFrame: At the moment of the delivery, between 1 day and 3
measure: APGAR score
timeFrame: At the moment of the delivery, between 1 day and 3
measure: Neonatal Intensive Care Unit (NICU) admission
timeFrame: From the delivery to discharge from hospital, between 1 and 7 days
measure: Neonatal antibiotic administracion
timeFrame: From the delivery to discharge from hospital, between 1 and 7 days
measure: Neonatal death
timeFrame: From the delivery to discharge from hospital, between 1 and 7 days
measure: Hypoxic-ischemic encephalopathy
timeFrame: From the delivery to discharge from hospital, between 1 and 7 days
measure: Neonatal seizures
timeFrame: From the delivery to discharge from hospital, between 1 and 7 days
measure: Neonatal intubation or chest compressions
timeFrame: From the delivery to discharge from hospital, between 1 and 7 days
measure: Persistent pulmonary hypertension of the newborn
timeFrame: From the delivery to discharge from hospital, between 1 and 7 days
measure: Pain/Discomfort
timeFrame: During insertion of the cervical balloon, between 1 and 3 minutes
measure: Pain/Discomfort
timeFrame: During cervical rippening, about 6 hours
measure: Labor Agentry Scale
timeFrame: Up to two months
measure: Edinburg questionnaire for postpartum depression
timeFrame: Up to two months
measure: Impact of Event Scale-Revised
timeFrame: Up to two months
measure: Breastfeeding
timeFrame: Up to two months
measure: SF-12 questionnaire
timeFrame: Up to two months
measure: Diagnosis of depression
timeFrame: Up to two months
measure: Medical costs
timeFrame: One year
Other outcomes:
measure: Maternal age
timeFrame: At time of recruitment and end of delivery, about 1 or 2 days
measure: Ethnicity
timeFrame: At time of recruitment and end of delivery, about 1 or 2 days
measure: Language spoken at home
timeFrame: At time of recruitment and end of delivery, about 1 or 2 days
measure: Socioeconomic data
timeFrame: At time of recruitment and end of delivery, about 1 or 2 days
measure: Height and weight
timeFrame: At time of recruitment and end of delivery, about 1 or 2 days
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Elisa Llurba Olivé
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Maria del Carmen Medina Mallén
role: STUDY_DIRECTOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Anna Mundó Fornell
role: STUDY_CHAIR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Ignacio Montoro Pacha
role: STUDY_CHAIR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Bruna Miarons Ferré
role: STUDY_CHAIR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Mitsury Flores
role: STUDY_CHAIR
References:
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.