Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor

A Comparison Between 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.

Study Overview

• Status: Completed
• Conditions: Induced; Birth
• Intervention / Treatment: Drug: Oxytocin; Drug: Oxytocin

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 Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intermittent treatment; Infusion of oxytocin for 6 hours at a time until patient delivers.	Drug: Oxytocin; Intermittent oxytocin Infusion; Drug: Oxytocin; Continous oxytocin Infusion for 16 hours
Active Comparator: Continous treatment; Infusion of oxytocin continuously from patient admission for 16 hours.	Drug: Oxytocin; Intermittent oxytocin Infusion; Drug: Oxytocin; Continous oxytocin Infusion for 16 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery within 24 hours	The percentage of women delivering within 24 hours.	from admission up to 24 hours postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
latent phase of labor.	Length of latent phase of labor.	from admission up to 24 hours postpartum
active phase of labor.	Length of active phase of labor.	from admission up to 24 hours postpartum
caesarian deliveries	The rate of caesarian deliveries.	from admission up to 24 hours postpartum
instrumental deliveries	The rate of instrumental deliveries.	from admission up to 24 hours postpartum

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Roy Lauterbach, MD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 0308-19-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No