NCT06053073UnknownNot Applicable
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
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 sites in 1 country834 target enrollmentStarted: March 27, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 834
- Locations
- 2
- Primary Endpoint
- Type of delivery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Type of delivery
Time Frame: End of the delivery
Vaginal birth, Cesarean section
Secondary Outcomes
- Fever during childbirth(At the moment of the delivery, between 1 day and 3)
- Neonatal seizures(From the delivery to discharge from hospital, between 1 and 7 days)
- Neonatal death(From the delivery to discharge from hospital, between 1 and 7 days)
- Pharmacological analgesia during the cervical rippening(During cervical rippening, about 6 hours)
- Indication of induction(1 day)
- Adverse outcomes(During cervical rippening and labor, between 6 hours and 3 days)
- Artificial Amniorrhexis(During cervical rippening and labor, between 6 hours and 3 days)
- Oxytocin infusion(During cervical rippening and labor, between 6 hours and 3 days)
- Subsequent PGE2 use(During cervical rippening and labor, between 6 hours and 3 days)
- Hyperstimulation(During cervical rippening and labor, between 6 hours and 3 days)
- Reason for instrumentation(At the moment of the delivery, between 1 day and 3)
- Days of postpartum hospitalization(From the delivery to discharge from hospital, between 1 and 7 days)
- Weeks of gestation(Only at time of recruitment, 1 day)
- Time of cervical rippening balloon(At the insertion of the rippening balloon and after removing it, about 6 hours)
- Partian emptying of the balloon due to pain(During cervical rippening, about 6 hours)
- Type of delivery(At the moment of the delivery, between 1 day and 3)
- Time to delivery(At the moment of the delivery, between 1 day and 3)
- Reason for Cesarean section(At the moment of the delivery, between 1 day and 3)
- Epidural anesthesia(During cervical rippening and labor, between 6 hours and 3 days)
- Perineal injuries(At the moment of the delivery, between 1 day and 3)
- Postpartum haemorrage(At the moment of the delivery, between 1 day and 3)
- Anemia(At the moment of the delivery, between 1 day and 3)
- Parity(At time of recruitment and end of delivery, about 1 or 2 days)
- Bishop score(Before inserting the rippening balloon and after removing it, about 6 hours)
- Time of dilatation(During labour and until delivery, between 1 and 3 days)
- Uterine rupture(At the moment of the delivery, between 1 day and 3)
- Maternal ICU admission(At the moment of the delivery, between 1 day and 3)
- Meconial amniotic fluid(During cervical rippening and labor, between 6 hours and 3 days)
- Sepsis(At the moment of the delivery, between 1 day and 3)
- APGAR score(At the moment of the delivery, between 1 day and 3)
- Arterial pH(At the moment of the delivery, between 1 day and 3)
- Venous pH(At the moment of the delivery, between 1 day and 3)
- Neonatal antibiotic administracion(From the delivery to discharge from hospital, between 1 and 7 days)
- Pain/Discomfort(During cervical rippening, about 6 hours)
- Labor Agentry Scale(Up to two months)
- Edinburg questionnaire for postpartum depression(Up to two months)
- Breastfeeding(Up to two months)
- Neonatal Intensive Care Unit (NICU) admission(From the delivery to discharge from hospital, between 1 and 7 days)
- Hypoxic-ischemic encephalopathy(From the delivery to discharge from hospital, between 1 and 7 days)
- Persistent pulmonary hypertension of the newborn(From the delivery to discharge from hospital, between 1 and 7 days)
- Neonatal intubation or chest compressions(From the delivery to discharge from hospital, between 1 and 7 days)
- Impact of Event Scale-Revised(Up to two months)
- SF-12 questionnaire(Up to two months)
- Diagnosis of depression(Up to two months)
- Medical costs(One year)
Investigators
Study Sites (2)
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