Induction to Labour With Double Cervical Ballon at Home Versus at Hospital
- Conditions
- Cervical DilatationLive BirthInduced; Birth
- Interventions
- Device: Cervical rippening at homeDevice: Cervical rippening in the hospital
- Registration Number
- NCT06053073
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 834
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description At home patients group Cervical rippening at home 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. Hospitalized patients group Cervical rippening in the hospital 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.
- Primary Outcome Measures
Name Time Method Type of delivery End of the delivery Vaginal birth, Cesarean section
- Secondary Outcome Measures
Name Time Method Fever during childbirth At the moment of the delivery, between 1 day and 3 Presence of absence
Neonatal seizures From the delivery to discharge from hospital, between 1 and 7 days Presence of absence
Indication of induction 1 day Cathegorical variable, it will be studied the different reason that motivated the induction to delivery for each patient
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
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
Days of postpartum hospitalization From the delivery to discharge from hospital, between 1 and 7 days Days
Weeks of gestation Only at time of recruitment, 1 day Measured in number of weeks and days
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
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 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
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
Parity At time of recruitment and end of delivery, about 1 or 2 days Number of pregnancies and deliveries of each patient
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
Pharmacological analgesia during the cervical rippening During cervical rippening, about 6 hours Number of drugs administered
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
Meconial amniotic fluid During cervical rippening and labor, between 6 hours and 3 days Presence of absence
Sepsis At the moment of the delivery, between 1 day and 3 Presence of absence
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
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
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
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
Breastfeeding Up to two months Presence of abscence
Neonatal Intensive Care Unit (NICU) admission From the delivery to discharge from hospital, between 1 and 7 days Days
Hypoxic-ischemic encephalopathy 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
Neonatal intubation or chest compressions From the delivery to discharge from hospital, between 1 and 7 days Presence of absence
Impact of Event Scale-Revised Up to two months Score obtained adding different items on the Scale
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
Trial Locations
- Locations (1)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain