Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04760496
Status:
RECRUITING
Last Update Posted:
2023-07-03
First Post:
2021-01-29
Brief Title:
Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour A Double-blind Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-06
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:
PROXYMA
Brief Summary:
The rate of caesarean section is higher among obese pregnant women leading to increased morbidity in this already vulnerable population Oxytocin is the main drug used in obstetrics to optimize progress of labour but observational studies have suggested that its efficiency may be insufficient in obese women with usual doses
We design a randomised controlled trial to test the effect of an increased oxytocin dose on the rate of caesarean section in obese primiparous women with spontaneous or induced labour
We design a randomised controlled trial to test the effect of an increased oxytocin dose on the rate of caesarean section in obese primiparous women with spontaneous or induced labour
Detailed Description:
The hypothesis underlying this trial is that an increase in oxytocin dose can reduce the rate of caesarean sections in primiparous obese patients with a spontaneous or induced onset of labour without increasing maternal or neonatal morbidity This would be a major step forward in reducing morbidity in an at-risk population and in improving the obstetric prognosis for future pregnancies
The research is a double-blind controlled trial including primiparous obese women in spontaneous or induced labour for whom a prescription of oxytocin is decided Oxytocin is currently indicated for notably insufficiency of uterine contractions at the beginning or during labourThe recommended dosage in the market authorization will be used for the control group
The control group will receive oxytocin at 2 milli-International unit mL and the intervention group at 4 milli-International unit mL controlled by pump final volume 500 mL or electrical syringe final volume 50 mL
The primary objective is to compare the effect of higher doses of oxytocin intervention group vs standard doses of oxytocin control group on the rate of caesarean sections in obese patients with spontaneous or induced onset of labour
The secondary objectives will be to compare the effect of higher doses of oxytocin intervention group vs standard doses of oxytocin control group on maternal and labour complications length of labour arrest of labour interruption of oxytocin perfusion and reason uterine hyper-stimulation mode of vaginal delivery reason for caesarean section post-partum haemorrhage maternal blood transfusion volume of oxytocin infusion oxytocin side effects as well as foetal complications and neonatal complications
The research is a double-blind controlled trial including primiparous obese women in spontaneous or induced labour for whom a prescription of oxytocin is decided Oxytocin is currently indicated for notably insufficiency of uterine contractions at the beginning or during labourThe recommended dosage in the market authorization will be used for the control group
The control group will receive oxytocin at 2 milli-International unit mL and the intervention group at 4 milli-International unit mL controlled by pump final volume 500 mL or electrical syringe final volume 50 mL
The primary objective is to compare the effect of higher doses of oxytocin intervention group vs standard doses of oxytocin control group on the rate of caesarean sections in obese patients with spontaneous or induced onset of labour
The secondary objectives will be to compare the effect of higher doses of oxytocin intervention group vs standard doses of oxytocin control group on maternal and labour complications length of labour arrest of labour interruption of oxytocin perfusion and reason uterine hyper-stimulation mode of vaginal delivery reason for caesarean section post-partum haemorrhage maternal blood transfusion volume of oxytocin infusion oxytocin side effects as well as foetal complications and neonatal complications
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