Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor

Not Applicable

Completed

• Conditions: Induced; Birth
• Interventions: Drug: Oxytocin

• Registration Number: NCT04017247
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-12
• Study Start: 2019-11-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 153

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent treatment	Oxytocin	Infusion of oxytocin for 6 hours at a time until patient delivers.
Continous treatment	Oxytocin	Infusion of oxytocin continuously from patient admission for 16 hours.

Primary Outcome Measures

Name	Time	Method
Delivery within 24 hours	from admission up to 24 hours postpartum	The percentage of women delivering within 24 hours.

Secondary Outcome Measures

Name	Time	Method
caesarian deliveries	from admission up to 24 hours postpartum	The rate of caesarian deliveries.
latent phase of labor.	from admission up to 24 hours postpartum	Length of latent phase of labor.
instrumental deliveries	from admission up to 24 hours postpartum	The rate of instrumental deliveries.
active phase of labor.	from admission up to 24 hours postpartum	Length of active phase of labor.

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel