Pregnancy RelatedNCT06372522
Oxytocin in Multiparous Women
A study testing Pitocin Injectable Product in people with Pregnancy Related, run by Rambam Health Care Campus.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Pitocin Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- multiparous women (women who have given birth one or more times in the past) with a singleton pregnancy that are admitted for induction of labor.
- Women at gestational age of 370/7 or more.
- Vertex presentation.
Who cannot join
- Age 18 and under.
- High order gestation.
- Women with contraindication for vaginal delivery.
- Previous cesarean delivery.
- Active labor.
- Documented fetal anomalies.
About this study
Official title: Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor in Multiparous Pregnant Women
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.
Read the 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 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.
- Conditions
- Pregnancy Related
- Being tested
- Pitocin Injectable Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitocin Injectable ProductDrug
Also called Synthetic Oxytocin
The primary dose of oxytocin is 1.0 mU/min, with an incremental increase by 2.5 mU/min every 30 minutes, until 20.0 mU/min, tittered to a target of 3-5 contractions in a 10-minute period, or active labor (dilatation > 6 cm).
| Study group | Role | What they receive |
|---|---|---|
| continuous oxytocin infusion | Experimental | continuous oxytocin infusion - women will continue to receive a continuous oxytocin infusion from start of labor augmentation until delivery. Receives: Drug: Pitocin Injectable Product |
| intermittent oxytocin infusion | Active comparator | intermittent oxytocin infusion - oxytocin transfusion will be discontinued after 8 hours if the woman does not go into active labor, or does not deliver in that period of time.
The second course of oxytocin will be renewed after 6 hours if the woman hasn't progressed into labor or hasn't given birth yet. Receives: Drug: Pitocin Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of women delivering within 24 hours.
number of women (among those who received continues Oxytocin) who manage to deliver within 24 hours from the beginning of the induction.
Measured: During admission for delivery (assessed up to 5 days since admission to delivery room)
Secondary outcomes (10)
Length of latent and active phases of labor.
Time interval from admission to delivery room to delivery of fetus
Measured: During admission for delivery
The rate of instrumental and caesarean deliveries.
Cesarean section and operative vaginal delivery including vacuum assisted vaginal delivery
Measured: During admission for delivery
chorioamnionitis
Chorioamnionitis diagnosed at discretion of primary provider during the second stage of labor
Measured: During admission for delivery
obstetric anal sphincter injuries (OASIS)
3rd or 4th degree perineal lacerations
Measured: During admission for delivery
hyponatremia
blood sodium lower than 135 while oxytocin admission
Measured: During admission for delivery
post-partum hemorrhage (PPH)
Estimated blood loss >500 mL for vaginal delivery and >1000 mL for cesarean delivery
Measured: During admission for delivery
neonatal outcome - 1 and 5-minute Apgar score
apgar score measured at 1 and 5 minutes after delivery
Measured: 1 and 5 minutes after delivery
umbilical artery pH
blood withdrawn from umbilical artery after delivery
Measured: During admission for delivery
NICU admission
neonatal admission to ICU unit
Measured: During admission for delivery
Women's satisfaction.
questionnaire - satisfaction scale, with number 1 as the worst score and number 5 as the highest/best score
Measured: up to 5 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiba Abu Rass MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372522
- Sponsor's protocol ID
- RMB-0517-23
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor in Multiparous Pregnant Women
- ClinicalTrials.gov ID
- NCT06372522
- Acronym / sponsor ID
- RMB-0517-23
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous oxytocin infusion | Experimental | Drug: Pitocin Injectable Productcontinuous oxytocin infusion - women will continue to receive a continuous oxytocin infusion from start of labor augmentation until delivery. |
| intermittent oxytocin infusion | Active comparator | Drug: Pitocin Injectable Productintermittent oxytocin infusion - oxytocin transfusion will be discontinued after 8 hours if the woman does not go into active labor, or does not deliver in that period of time. The second course of oxytocin will be renewed after 6 hours if the woman hasn't progressed into labor or hasn't given birth yet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- multiparous women (women who have given birth one or more times in the past) with a singleton pregnancy that are admitted for induction of labor.
- Women at gestational age of 370/7 or more.
- Vertex presentation.
Key exclusion criteria (6 listed)
- Age 18 and under.
- High order gestation.
- Women with contraindication for vaginal delivery.
- Previous cesarean delivery.
- Active labor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pitocin Injectable ProductAlso: Synthetic OxytocinThe primary dose of oxytocin is 1.0 mU/min, with an incremental increase by 2.5 mU/min every 30 minutes, until 20.0 mU/min, tittered to a target of 3-5 contractions in a 10-minute period, or active labor (dilatation > 6 cm). | Drug | continuous oxytocin infusion, intermittent oxytocin infusion |
Primary outcome
The rate of women delivering within 24 hours.
Time frame: During admission for delivery (assessed up to 5 days since admission to delivery room)
number of women (among those who received continues Oxytocin) who manage to deliver within 24 hours from the beginning of the induction.
10 secondary outcomes
Length of latent and active phases of labor.
Time frame: During admission for delivery
The rate of instrumental and caesarean deliveries.
Time frame: During admission for delivery
chorioamnionitis
Time frame: During admission for delivery
obstetric anal sphincter injuries (OASIS)
Time frame: During admission for delivery
hyponatremia
Time frame: During admission for delivery
post-partum hemorrhage (PPH)
Time frame: During admission for delivery
neonatal outcome - 1 and 5-minute Apgar score
Time frame: 1 and 5 minutes after delivery
umbilical artery pH
Time frame: During admission for delivery
NICU admission
Time frame: During admission for delivery
Women's satisfaction.
Time frame: up to 5 days after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pitocin Injectable Product in people with Pregnancy Related, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of women delivering within 24 hours. (time frame: During admission for delivery (assessed up to 5 days since admission to delivery room)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.