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NCT Number: NCT06372522

Oxytocin in Multiparous 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Age 18 and under.
  • High order gestation.
  • Women with contraindication for vaginal delivery.
  • Previous cesarean delivery.
  • Active labor.
  • Documented fetal anomalies.

Treatment and study plan

Pitocin Injectable Product

Drug

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).

Other names: Synthetic Oxytocin

Primary outcomes

  1. 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.

Secondary outcomes

  1. Length of latent and active phases of labor.

    Time frame: During admission for delivery

    Time interval from admission to delivery room to delivery of fetus

  2. The rate of instrumental and caesarean deliveries.

    Time frame: During admission for delivery

    Cesarean section and operative vaginal delivery including vacuum assisted vaginal delivery

  3. chorioamnionitis

    Time frame: During admission for delivery

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

  4. obstetric anal sphincter injuries (OASIS)

    Time frame: During admission for delivery

    3rd or 4th degree perineal lacerations

  5. hyponatremia

    Time frame: During admission for delivery

    blood sodium lower than 135 while oxytocin admission

  6. post-partum hemorrhage (PPH)

    Time frame: During admission for delivery

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

  7. neonatal outcome - 1 and 5-minute Apgar score

    Time frame: 1 and 5 minutes after delivery

    apgar score measured at 1 and 5 minutes after delivery

  8. umbilical artery pH

    Time frame: During admission for delivery

    blood withdrawn from umbilical artery after delivery

  9. NICU admission

    Time frame: During admission for delivery

    neonatal admission to ICU unit

  10. Women's satisfaction.

    Time frame: up to 5 days after delivery

    questionnaire - satisfaction scale, with number 1 as the worst score and number 5 as the highest/best score

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor in Multiparous Pregnant Women

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 18, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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