Status:
RECRUITING
Induction to Labour With Double Cervical Ballon at Home Versus at Hospital
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Induced; Birth
Cervical Dilatation
Eligibility:
FEMALE
18+ years
Phase:
NA
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 w...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
834 Patients enrolled
Trial Details
Trial ID
NCT06053073
Start Date
March 27 2023
End Date
March 1 2026
Last Update
September 25 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025