Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06372522 |
| Other study ID # |
RMB-0517-23 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2024 |
| Est. completion date |
April 2027 |
Study information
| Verified date |
April 2024 |
| Source |
Rambam Health Care Campus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 4.2 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 patient's 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.
