Clinical trial NCT04017247: Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor
Official title: A Comparison Between Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced; Birth
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Age under 18 or over 45.
2. High order gestation.
3. Women with contraindication for vaginal delivery.
4. Active labor.
5. Women with a uterine scar.
6. Multiparity(\> 5 deliveries).
7. Documented fetal anomalies.

Primary outcomes:
measure: Delivery within 24 hours
timeFrame: from admission up to 24 hours postpartum
Secondary outcomes:
measure: latent phase of labor.
timeFrame: from admission up to 24 hours postpartum
measure: active phase of labor.
timeFrame: from admission up to 24 hours postpartum
measure: caesarian deliveries
timeFrame: from admission up to 24 hours postpartum
measure: instrumental deliveries
timeFrame: from admission up to 24 hours postpartum
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Principal Investigator
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References: