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Pregnancy RelatedNCT06372522

Oxytocin in Multiparous Women

A study testing Pitocin Injectable Product in people with Pregnancy Related, run by Rambam Health Care Campus.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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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.

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 groups in NCT06372522
Study groupRoleWhat they receive
continuous oxytocin infusionExperimentalcontinuous 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 infusionActive comparatorintermittent 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.

  1. 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)
  1. Length of latent and active phases of labor.

    Time interval from admission to delivery room to delivery of fetus

    Measured: During admission for delivery

  2. The rate of instrumental and caesarean deliveries.

    Cesarean section and operative vaginal delivery including vacuum assisted vaginal delivery

    Measured: During admission for delivery

  3. chorioamnionitis

    Chorioamnionitis diagnosed at discretion of primary provider during the second stage of labor

    Measured: During admission for delivery

  4. obstetric anal sphincter injuries (OASIS)

    3rd or 4th degree perineal lacerations

    Measured: During admission for delivery

  5. hyponatremia

    blood sodium lower than 135 while oxytocin admission

    Measured: During admission for delivery

  6. post-partum hemorrhage (PPH)

    Estimated blood loss >500 mL for vaginal delivery and >1000 mL for cesarean delivery

    Measured: During admission for delivery

  7. 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

  8. umbilical artery pH

    blood withdrawn from umbilical artery after delivery

    Measured: During admission for delivery

  9. NICU admission

    neonatal admission to ICU unit

    Measured: During admission for delivery

  10. 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.

  1. First posted18 Apr 2024
  2. Study startApr 2024 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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)
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

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.

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