Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Induced; Birth

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with a singleton pregnancy that are admitted for induction or augmentation of labor. Women at gestational age 370/7 or more. Vertex presentation. Exclusion Criteria: Age under 18 or over 45. High order gestation. Women with contraindication for vaginal delivery. Active labor. Women with a uterine scar. Multiparity(> 5 deliveries). Documented fetal anomalies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |