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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
834
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
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
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
RECRUITINGType of delivery
Vaginal birth, Cesarean section
Time frame: End of the delivery
Parity
Number of pregnancies and deliveries of each patient
Time frame: 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
Time frame: 1 day
Weeks of gestation
Measured in number of weeks and days
Time frame: Only at time of recruitment, 1 day
Bishop score
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
Time of dilatation
Hours
Time frame: During labour and until delivery, between 1 and 3 days
Time of cervical rippening balloon
Hours
Time frame: At the insertion of the rippening balloon and after removing it, about 6 hours
Partian emptying of the balloon due to pain
Milliliters
Time frame: During cervical rippening, about 6 hours
Pharmacological analgesia during the cervical rippening
Number of drugs administered
Time frame: During cervical rippening, about 6 hours
Adverse outcomes
Number of adverse outcomes
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Artificial Amniorrhexis
Presence or absence
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Oxytocin infusion
Presence or absence
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Subsequent PGE2 use
Presence or absence
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Hyperstimulation
Presence or absence
Time frame: 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
Time frame: At the moment of the delivery, between 1 day and 3
Time to delivery
Hours
Time frame: 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
Time frame: 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
Time frame: At the moment of the delivery, between 1 day and 3
Epidural anesthesia
Presence of absence
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Days of postpartum hospitalization
Days
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Fever during childbirth
Presence of absence
Time frame: At the moment of the delivery, between 1 day and 3
Perineal injuries
Presence of absence
Time frame: At the moment of the delivery, between 1 day and 3
Postpartum haemorrage
Presence of absence
Time frame: At the moment of the delivery, between 1 day and 3
Anemia
Presence of absence
Time frame: At the moment of the delivery, between 1 day and 3
Uterine rupture
Presence of absence
Time frame: At the moment of the delivery, between 1 day and 3
Maternal ICU admission
Presence of absence
Time frame: At the moment of the delivery, between 1 day and 3
Sepsis
Presence of absence
Time frame: At the moment of the delivery, between 1 day and 3
Meconial amniotic fluid
Presence of absence
Time frame: During cervical rippening and labor, between 6 hours and 3 days
Arterial pH
pH value of neonatal umbilical artery
Time frame: At the moment of the delivery, between 1 day and 3
Venous pH
pH value of neonatal umbilical vein
Time frame: 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
Time frame: At the moment of the delivery, between 1 day and 3
Neonatal Intensive Care Unit (NICU) admission
Days
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Neonatal antibiotic administracion
Presence of absence
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Neonatal death
Presence of absence
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Hypoxic-ischemic encephalopathy
Presence of absence
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Neonatal seizures
Presence of absence
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Neonatal intubation or chest compressions
Presence of absence
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Persistent pulmonary hypertension of the newborn
Presence of absence
Time frame: From the delivery to discharge from hospital, between 1 and 7 days
Pain/Discomfort
Measure with analogue scale from 1 to 10
Time frame: During insertion of the cervical balloon, between 1 and 3 minutes
Pain/Discomfort
Measure with analogue scale from 1 to 10
Time frame: During cervical rippening, about 6 hours
Labor Agentry Scale
Score obtained adding different items on the Scale
Time frame: Up to two months
Edinburg questionnaire for postpartum depression
Score obtained adding different items on the Scale
Time frame: Up to two months
Impact of Event Scale-Revised
Score obtained adding different items on the Scale
Time frame: Up to two months
Breastfeeding
Presence of abscence
Time frame: Up to two months
SF-12 questionnaire
Score obtained adding different items on the Scale
Time frame: Up to two months
Diagnosis of depression
Presence or Absence
Time frame: Up to two months
Medical costs
Measured in euros
Time frame: One year
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