Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor

  • STATUS
    Recruiting
  • End date
    Apr 1, 2022
  • participants needed
    200
  • sponsor
    Rambam Health Care Campus
Updated on 23 March 2021

Summary

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.

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

Description

At enrollment, after consenting to participate in the study, patients will be assigned randomly to either routine oxytocin (intermittent) treatment or continuous oxytocin treatment.

Both groups will follow the institutional oxytocin protocol. The primary dose of oxytocin is 2.0 mU/min, with an incremental increase by 5.0 mU/min every 30 minutes, until 40.0 mU/min, tittered to a target of 3-5 contractions in a 10-minute period, or active labor (dilatation > 6 cm). Women will be continuously monitored to fetal heart rate while oxytocin is administered.

In the intermittent group, oxytocin will be discontinued after 6-8 hours if the patient does not go into active labor in that period of time. The second course of oxytocin will be renewed after 8-12 hours. In the continuous group, women will receive a continuous oxytocin infusion until delivery, unless there is an indication to stop the infusion, including; category II fetal tracing, uterine tachysystole (an average of more than 5 contractions in 10 minutes for more than 30 minutes).

During oxytocin infusion, sodium levels will be monitored every four hours. In cases where the maternal sodium is below 125 mmol/L oxytocin should be stopped. The decision regarding further oxytocin administration should be made following assessment of the woman's clinical condition and circumstances after discussion with a consultant obstetrician.

Details
Condition Induced; Birth, Induced; Birth, Induced; Birth, Induced; Birth, Induced; Birth, Induced; Birth
Treatment Oxytocin
Clinical Study IdentifierNCT04017247
SponsorRambam Health Care Campus
Last Modified on23 March 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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