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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Induction Dosage in Latent Phase Affect Active Phase of Labor?A Randomized Study

Conditions
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Oxytocin, Induction of Labor

Intervention / Treatment
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* Drug: oxytocin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low dose group<br>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. | Drug: oxytocin<br>* one group will be treated with low dose oxytocin and the other group will be treated with high dose oxytocin for augmentation of labor induction.<br>* Other names: synpitan;|
| Active Comparator: high dose group<br>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. | Drug: oxytocin<br>* one group will be treated with low dose oxytocin and the other group will be treated with high dose oxytocin for augmentation of labor induction.<br>* Other names: synpitan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for oxytocin retreatment | need for oxytocin retreatment due to inadequate uterine contractions and labor arrest | an average of one year | 

Secondary Outcome Measures

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