Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor

Induced; Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017247
• Other study ID #: 0308-19-RMB
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2023
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Induced; Birth

Intervention

Drug:
• Oxytocin
Intermittent oxytocin Infusion
• Oxytocin
Continous oxytocin Infusion for 16 hours

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery within 24 hours	The percentage of women delivering within 24 hours.	from admission up to 24 hours postpartum
Secondary	latent phase of labor.	Length of latent phase of labor.	from admission up to 24 hours postpartum
Secondary	active phase of labor.	Length of active phase of labor.	from admission up to 24 hours postpartum
Secondary	caesarian deliveries	The rate of caesarian deliveries.	from admission up to 24 hours postpartum
Secondary	instrumental deliveries	The rate of instrumental deliveries.	from admission up to 24 hours postpartum