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Completed

NCT Number: NCT04017247

Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor

The study will compare 2 treatment modalities. One group will receive the routine protocol of intermittent pitocin induction for 6 hours and the second group will receive continous pitocin infusion for 16 hours.

The primary aim is to observe which protocol leads to the fastest delivery and evaluate the time in each group from induction to delivery.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam health care campus

Haifa, Israel

About this study

After singing an informed consent, and prior to IOL initiation, study participants were randomly assigned (1:1) to receive either intermittent or continuous Oxytocin infusion. Both groups received the same primary infusion dose of Oxytocin 1.0 with an incremental increase of 2.5 every 30 minutes until 20, titered to a target of 3-5 contractions in a 10 minute period. During Oxytocin infusion, fetal heart rate was continuously monitored. Artificial ROM was performed according to the accepted indications, local protocol and by the staff physician discretion who was in charge on the labor ward at that time, regardless of oxytocin initiation time. In the intermittent Oxytocin infusion group, Oxytocin was discontinued after 8 h if the patient did not go into active labor during by that time, and renewed 4 h later. In the continuous infusion group, patients received a continuous Oxytocin infusion for 16 h. If they did not go into active labor within this frame time, Oxytocin was discontinued for 4 hours and then resumed. In addition, during Oxytocin infusion, sodium levels were monitored every 8 h.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with a singleton pregnancy that are admitted for induction or augmentation of labor.
  • Women at gestational age 370/7 or more.
  • Vertex presentation.

Exclusion criteria

  • Age under 18 or over 45.
  • High order gestation.
  • Women with contraindication for vaginal delivery.
  • Active labor.
  • Women with a uterine scar.
  • Multiparity(> 5 deliveries).
  • Documented fetal anomalies.

Treatment and study plan

Oxytocin

Drug

Intermittent oxytocin Infusion

Primary outcomes

  1. Delivery within 24 hours

    Time frame: from admission up to 24 hours postpartum

    The percentage of women delivering within 24 hours.

Secondary outcomes

  1. latent phase of labor.

    Time frame: from admission up to 24 hours postpartum

    Length of latent phase of labor.

  2. active phase of labor.

    Time frame: from admission up to 24 hours postpartum

    Length of active phase of labor.

  3. caesarian deliveries

    Time frame: from admission up to 24 hours postpartum

    The rate of caesarian deliveries.

  4. instrumental deliveries

    Time frame: from admission up to 24 hours postpartum

    The rate of instrumental deliveries.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

A Comparison Between Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2019
Registry last updated
Sep 13, 2023

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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