Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor

Rambam Health Care Campus

Status: Completed

Conditions: Induced; Birth

Treatments: Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT04017247

0308-19-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 153 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Intermittent treatment

Active Comparator group

Description:

Infusion of oxytocin for 6 hours at a time until patient delivers.

Treatment:

Drug: Oxytocin

Drug: Oxytocin

Continous treatment

Active Comparator group

Description:

Infusion of oxytocin continuously from patient admission for 16 hours.

Treatment:

Drug: Oxytocin

Drug: Oxytocin