Overview

This trial is active, not recruiting.

Condition intemittant, continue, oxytocin
Treatment oxytocin
Phase phase 2
Sponsor Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Start date August 2016
End date October 2016
Trial size 200 participants
Trial identifier NCT02859571, 152

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
oxytocin
(Experimental)
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.
oxytocin

Primary Outcomes

Measure
induction-to-delivery time
time frame: intraoperative

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Zeynep Kamil Maternity and Pediatric Research and Training Hospital.