Does Induction Dosage in Latent Phase Affect Active Phase of Labor?

Phase 2

Completed

• Conditions: Induction of Labor; Oxytocin
• Interventions: Drug: oxytocin

• Registration Number: NCT03742531
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief Summary

This study evaluates the need of oxytocin therapy in active phase of labor. there will be two groups treating with oxytocin in latent phase.One group will be treated with low dose oxytocin therapy and the other group will be treated with high dose oxytocin therapy. oxytocin treatment will be ceased at the beginning of the active phase of labor. the need of oxytocin treatment in active phase of labor will be compared between two groups.

Detailed Description

Oxytocin treatment in active phase of labour is used with respect to clinicians preference and best approach has not been described. We want to investigate the effect of oxytocin treatment by using different regims in latent phase of labor when oxytocin treatment is ceased in active phase of labour. In our trial we discontinued oxytocin in active phase of labour and investigate which group needs oxytocin therapy due to inadequate uterine contractions and arrest of labor.

Study Timeline

• Study First Submitted: 2018-03-25
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Study Start: 2018-12-15
• Primary Completion: 2019-06-15
• Study Completion: 2019-12-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-18
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Live fetus in cephalic presentation, sonographically estimated fetal weight less than 4200 g, undergoing induction of labor at 37-42 weeks of gestation, having indications of labor, no previous uterine surgery

Exclusion Criteria

• malpresentation, placenta previa, previous uterine surgery, multiple gestation, active genital herpes, non-reassuring fetal heart rate pattern

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose group	oxytocin	oxytocin therapy starting with 4mU/min increased by 4 mU/min every 15 minutes. oxytocin will be stopped at the beginning of the active phase of labor.
low dose group	oxytocin	oxytocin therapy starting with 2mU/min increased by 2 mU/min every 15 minutes. oxytocin will be stopped at the beginning of the active phase of labor.

Primary Outcome Measures

Name	Time	Method
need for oxytocin retreatment	an average of one year	need for oxytocin retreatment due to inadequate uterine contractions and labor arrest

Secondary Outcome Measures

Name	Time	Method
total oxytocin dose	an average of one year	total amount of oxytocin treatment in latent and active phase of labor
APGAR scores	an average of one year	neonatal 1 minute and 5-minute-APGAR scores
length of active phase	an average of one year	duration of acive phase of labor
ratio of caesarean section	an average of one year	caesaraen section rate in total delivery

Trial Locations

Locations (1)

Zeynep Kamil Education and Research Hospital; 🇹🇷 Istanbul, Turkey