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

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status and phase: Unknown; Phase 2

Conditions: Intemittant, Continue, Oxytocin

Treatments: Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02859571

152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Continuous oxytocin

Active Comparator group

Description:

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.

Treatment:

Drug: Oxytocin

intermittent oxytocin

Experimental group

Description:

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.

Treatment:

Drug: Oxytocin