Continuous Versus Intermittent Oxytocin for Induction of Labor: A Randomized Study

Phase 2

• Conditions: Intemittant, Continue, Oxytocin
• Interventions: Drug: Oxytocin

• Registration Number: NCT02859571
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief Summary

This study evaluates continuous oxytocin versus intermittent oxytocin for induction of labor at term. Half of participants will be taken continuous oxytocin, while the other half will be taken intermittent oxytocin.

Detailed Description

In the continuous oxytocin group, traditional treatment of oxytocin used at a starting dose of 1-2 mIU/min and the dose was increased by 2 mIU/min at every 15 minutes until regular contractions obtained at a rate of 3-5 contractions in a 10-minute period. The maximum dose of oxytocin was 40 mIU/min and oxytocin was administered until delivery. In the intermittent group, oxytocin was discontinued when cervical dilation was 5 cm and 2 hours after discontinuation oxytocin was reused at a starting dose of 1-2 mIU/min and was increased as the same protocol used for continuation oxytocin group.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-09
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-08
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• singleton pregnancy,
• 37≤ weeks of gestational age ,
• vertex presentation,
• women with cervical dilation 3 cm
• no contraindication to vaginal delivery.

Exclusion Criteria

• fetal malpresentation,
• multifetal pregnancy,
• more than three contractions in 10 minutes,
• contraindications to oxytocin,
• a category II or III fetal heart rate pattern,
• fetal anomaly,
• fetal demise
• women with immediate delivery indications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intermittent oxytocin	Oxytocin	oxytocin will be discontinued when cervical dilation will 5 cm and 2 hours after discontinuation oxytocin will be reused at a starting dose of 1-2 mIU/min and will be increased as the same protocol will be used for continuation oxytocin group.
Continuous oxytocin	Oxytocin	oxytocin will be used at a starting dose of 1-2 mIU/min and the dose will be increased by 2 mIU/min at every 15 minutes until regular contractions will be obtained at a rate of 3-5 contractions in a 10-minute period. The maximum dose of oxytocin will 40 mIU/min and oxytocin will be administered until delivery.

Primary Outcome Measures

Name	Time	Method
induction-to-delivery time	intraoperative

Trial Locations

Locations (1)

Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology; 🇹🇷 Istanbul, Turkey