Induction to Labour With Double Cervical Ballon at Home Versus at Hospital (NCT06053073) | Clinical Trial Compass
UnknownNot Applicable
Induction to Labour With Double Cervical Ballon at Home Versus at Hospital
Spain834 participantsStarted 2023-03-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Ac…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Type of delivery
Timeframe: End of the delivery
Trial details
NCT IDNCT06053073
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau