Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372522
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-02-28
Brief Title:
Oxytocin in Multiparous Women
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor in Multiparous Pregnant Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
This is a randomized controlled trial investigating whether continuous oxytocin infusion in multiparous women shortens time to delivery without altering maternal or neonatal outcomes in augmented deliveries compared to intermittent infusion
Detailed Description:
Induction of labor IOL is defined as an artificial initiation of uterine contractions before the spontaneous onset of labor It is indicated when maternal or fetal risks associated with continuation of pregnancy outweigh the risks associated with early delivery Augmentation of labor refers to the stimulation of spontaneous but inadequate contractions In high-income countries up to 25 of all deliveries at term involve IOL
Bishop score is a scoring system which measures changes in the cervix It is based on several characteristics such as cervical effacement dilatation consistency position and fetus head station A Bishop score 6 is often referred to as an unripe cervix unfavorable whereas 6 is referred to as a rip cervix favorable
Oxytocin is a commonly used drug for IOL especially in a favorable cervix It is a mammalian neuro-hypophyseal hormone and is used to generate regular coordinated contractions originating from the fundus towards the cervix It is administered intravenously IV as an increasing infusion titrated to the strength and frequency of uterine contractions
There is voluminous experience with oxytocin and it is considered as a safe drug Although there are several case reports reporting rare serious side effects such as iatrogenic hyponatremia grand mal seizure and coma and maternal death In a prospective observational study of 287 women at term demonstrated that hyponatremia was correlated significantly with fluid infusion during labor and not to oxytocin administration
There is conflicting evidence whether oxytocin infusion should be continued during the active phase of labor or not Prolonged administration of oxytocin may increase the risk of tachysystole and uterine rupture which may result in fetal non-reassuring heart rate and caesarian deliveries Conversely discontinuing oxytocin infusion after a few hours may have an effect on time to delivery interval duration of rupture of membrane ROM and chorioamnionitis
one study had shown in an in vitro study that continuous exposure of human myometrial cells to oxytocin led to a loss of responsiveness to oxytocin Another study examined myometrial cell cultures from women undergoing cesarean delivery emergent and elective They showed that pretreatment of the cells with oxytocin resulted in a decrease in the percentage of myometrial cells that responded to subsequent oxytocin exposure They found that preliminary exposure of 42 hours to oxytocin yielded half-inactivation to the second exposure
the investigators have previously investigated whether oxytocin infusion duration increases 24-hour delivery rates and affects time to delivery length and patients experience in nulliparous women The investigators results showed that continuous infusion of oxytocin for labor induction in nulliparous women with a favorable cervix may be superior over intermittent oxytocin infusion since it shortens time-to delivery decreases chorioamnionitis rate and improves maternal satisfaction without affecting adverse maternal or neonatal outcomes
In this study the investigators aim is to investigate whether continuous administration of oxytocin is superior to intermittent administration also in multiparous women in terms of time to delivery and the percentage of women delivering within 24 hours
Bishop score is a scoring system which measures changes in the cervix It is based on several characteristics such as cervical effacement dilatation consistency position and fetus head station A Bishop score 6 is often referred to as an unripe cervix unfavorable whereas 6 is referred to as a rip cervix favorable
Oxytocin is a commonly used drug for IOL especially in a favorable cervix It is a mammalian neuro-hypophyseal hormone and is used to generate regular coordinated contractions originating from the fundus towards the cervix It is administered intravenously IV as an increasing infusion titrated to the strength and frequency of uterine contractions
There is voluminous experience with oxytocin and it is considered as a safe drug Although there are several case reports reporting rare serious side effects such as iatrogenic hyponatremia grand mal seizure and coma and maternal death In a prospective observational study of 287 women at term demonstrated that hyponatremia was correlated significantly with fluid infusion during labor and not to oxytocin administration
There is conflicting evidence whether oxytocin infusion should be continued during the active phase of labor or not Prolonged administration of oxytocin may increase the risk of tachysystole and uterine rupture which may result in fetal non-reassuring heart rate and caesarian deliveries Conversely discontinuing oxytocin infusion after a few hours may have an effect on time to delivery interval duration of rupture of membrane ROM and chorioamnionitis
one study had shown in an in vitro study that continuous exposure of human myometrial cells to oxytocin led to a loss of responsiveness to oxytocin Another study examined myometrial cell cultures from women undergoing cesarean delivery emergent and elective They showed that pretreatment of the cells with oxytocin resulted in a decrease in the percentage of myometrial cells that responded to subsequent oxytocin exposure They found that preliminary exposure of 42 hours to oxytocin yielded half-inactivation to the second exposure
the investigators have previously investigated whether oxytocin infusion duration increases 24-hour delivery rates and affects time to delivery length and patients experience in nulliparous women The investigators results showed that continuous infusion of oxytocin for labor induction in nulliparous women with a favorable cervix may be superior over intermittent oxytocin infusion since it shortens time-to delivery decreases chorioamnionitis rate and improves maternal satisfaction without affecting adverse maternal or neonatal outcomes
In this study the investigators aim is to investigate whether continuous administration of oxytocin is superior to intermittent administration also in multiparous women in terms of time to delivery and the percentage of women delivering within 24 hours
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?:
False
Is an FDA AA801 Violation?:
None