An observational study in Induction of Labour, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-15.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
The goal of induction of labor is to achieve vaginal delivery by stimulating uterine contractions before the spontaneous onset of labor. Generally, induction of labor has merit as a therapeutic option when the benefits of expeditious delivery outweigh the risks of continuing the pregnancy.
The first part of this process is called cervical ripening. The goal is to facilitate the process of cervical softening, thinning, and dilating with resultant reduction in the rate of failed induction and induction to delivery time. Cervical remodeling is a critical component of normal parturition.
Effective methods for cervical ripening include the use of mechanical and pharmacological methods.
There are many induction methods: pharmacological and mechanical.
Nowadays, induction of labour is one of the most frequent obstetric interventions, performed in 25% of pregnancies. Generally, better maternal and neonatal outcomes are achieved if the risks of continuing pregnancy outweigh the benefits.
Cervical ripening is the first part of the induction process, which consists in relaxing and softening the uterine cervix prior to the onset of uterine dynamics.
For this purpose, there are available pharmacological (mainly prostaglandin) and mechanical methods (including the balloon probes: Foley catheter or double cervical balloon). Despite being equally effective in vaginal delivery and caesarean section rate, there has been registered an increased risk of uterine hyperdynamic with the use of prostaglandin in contrast to the use of balloon probes, which may lead to an increased risk of fetal distress.
Concerning balloon probes, various published studies conclude that it is an effective and safe cervical ripening method, without increasing the risk of maternal infection (chorioamnionitis / endometritis) or neonatal infection.
The use of balloon probes could be established as first-choice method of induction of labour, reducing the risk of uterine hyperdynamic and the likelihood of intrauterine fetal distress derived from the use of prostaglandin.
The balloon probe safety makes it an ideal method for performing cervical ripening at home (out-patient) in low-risk pregnancies, increasing the satisfaction of women who desire it and reducing the economic cost for the hospital.
The purpose of this study is to assess the effectiveness and safety of double balloon catheter (CRB-Cook®) in induction of labour.
The main objective is to provide evidence that there are no differences in caesarean section rate between induction of labour performed with Cook double balloon catheter in out-patient and in-patient compared with a cohort of induction of labour with pharmacological methods (dinoprostone and misoprostol).
Two clinical studies will be carried out for this purpose:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women
Inclusion Criteria:
Exclusion Criteria:
Vaginal delivery contraindication
Also, patients to be included in the out-patient group should comply with the following criteria:
Inclusion criteria:
Exclusion criteria:
Induction of labour with double balloon catheter
Effectiveness Vaginal delivery / caesarean section rate
Measure vaginal delivery and caesarean rate of induction of labour with double balloon catheter
Time frame: 12 months
Safety of patient and foetus
Measured through complications and adverse effects registered during induction of labour
Time frame: 12 months
Patients satisfaction
Measured as global satisfaction with the use of double balloon catheter as induction of labour method with an analog visual scale from 0 to 10
Time frame: 12 months
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau