Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774236
Status:
RECRUITING
Last Update Posted:
2023-04-25
First Post:
2023-03-07
Brief Title:
Cooks Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction
Sponsor:
Hospital Universitario 12 de Octubre
Organization:
Hospital Universitario 12 de Octubre
Study Overview
Official Title:
Cooks Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction COLIGROW
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLIGROW
Brief Summary:
The goal of this clinical trial is to compare how two methods for cervical ripening work in a population of singleton pregnancies with late-onset fetal growth restriction FGR at term
The main question it aims to answer is whether Cooks balloon a mechanical method is superior to vaginal dinoprostone a pharmacological method in achieving a vaginal delivery without increasing neonatal morbidity
Participants will be randomized to receive Cooks balloon experimental group or vaginal dinoprostone control group for cervical ripening
Researchers will compare both groups to see if Cooks balloon is associated with a higher rate of vaginal delivery than vaginal dinoprostone and is not related to increased neonatal morbidity
The main question it aims to answer is whether Cooks balloon a mechanical method is superior to vaginal dinoprostone a pharmacological method in achieving a vaginal delivery without increasing neonatal morbidity
Participants will be randomized to receive Cooks balloon experimental group or vaginal dinoprostone control group for cervical ripening
Researchers will compare both groups to see if Cooks balloon is associated with a higher rate of vaginal delivery than vaginal dinoprostone and is not related to increased neonatal morbidity
Detailed Description:
Late-onset fetal growth restriction FGR represents the most common subtype of FGR 70-80 The greatest risk for these fetuses appears once term pregnancy is reached when stressful situations are added to their status of relative hypoxia such as the appearance of contractions and funicular compression Thus it has been shown that from week 37-38 the risk of intrauterine mortality increases and there is a general consensus not to prolong these pregnancies beyond this period In this situation induction of labor is usually preferred over elective caesarean delivery However these fetuses have an increased risk of cesarean section for suspected fetal distress
Mechanical methods for cervical ripening are associated with less uterine stimulation with a lower rate of tachysystole than prostaglandins Therefore these methods have been proposed as the optimal approach for late-onset FGR since they could reduce the rate of cesarean sections for suspected fetal distress However there is no published randomized controlled trials on the use of different methods of cervical ripening for labor induction in late-onset FGR
Thus the investigators postulate that in late-onset FGR cervical ripening with a mechanical method Cooks balloon achieves a higher percentage of vaginal deliveries than a pharmacological method vaginal dinoprostone being safe for both the mother and the newborn
The main aim of this study is to evaluate whether cervical ripening with Cook balloon for labor induction at term gestation of singleton pregnancies with late-onset FGR achieves a higher rate of vaginal delivery compared to the use of vaginal dinoprostone without increasing neonatal morbidity
Mechanical methods for cervical ripening are associated with less uterine stimulation with a lower rate of tachysystole than prostaglandins Therefore these methods have been proposed as the optimal approach for late-onset FGR since they could reduce the rate of cesarean sections for suspected fetal distress However there is no published randomized controlled trials on the use of different methods of cervical ripening for labor induction in late-onset FGR
Thus the investigators postulate that in late-onset FGR cervical ripening with a mechanical method Cooks balloon achieves a higher percentage of vaginal deliveries than a pharmacological method vaginal dinoprostone being safe for both the mother and the newborn
The main aim of this study is to evaluate whether cervical ripening with Cook balloon for labor induction at term gestation of singleton pregnancies with late-onset FGR achieves a higher rate of vaginal delivery compared to the use of vaginal dinoprostone without increasing neonatal morbidity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-001726-22 | EUDRACT_NUMBER | None | None |
| PI19_01005 | OTHER_GRANT | Instituto de Salud Carlos III | None |