Induction of Labour Clinical Trial
Official title:
Effectiveness and Safety of Induction of Labour Using a Double Balloon Catheter (INDOBA)
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:
1. Prospective cohort observational study
2. Historical case-control study
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02242214 -
REgistry of MisOprostol 200 µg Vaginal dElivery System
|
N/A | |
| Terminated |
NCT02932319 -
Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy
|
N/A | |
| Not yet recruiting |
NCT04743297 -
Propess Versus Prostin for Induction of Labour in Women With Term PROM
|
Phase 4 | |
| Not yet recruiting |
NCT04887493 -
To Study the Efficacy and Safety of Misoprostol by Sublingual Routes for Induction of Labour
|
N/A | |
| Completed |
NCT04454346 -
Double Foley Catheter For Cervical Ripening
|
N/A | |
| Completed |
NCT00299754 -
Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)
|
Phase 3 | |
| Completed |
NCT04477226 -
Transvaginal Ultrasound As Predictors of Successful Induction of Labour
|
||
| Completed |
NCT03355040 -
Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.
|
||
| Completed |
NCT03489928 -
Misoprostol Labour Induction Study
|
Phase 3 |