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Completed

NCT Number: NCT03742531

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Zeynep Kamil Education and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

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.

Other names: synpitan

Primary outcomes

  1. need for oxytocin retreatment

    Time frame: an average of one year

    need for oxytocin retreatment due to inadequate uterine contractions and labor arrest

Secondary outcomes

  1. length of active phase

    Time frame: an average of one year

    duration of acive phase of labor

  2. ratio of caesarean section

    Time frame: an average of one year

    caesaraen section rate in total delivery

  3. total oxytocin dose

    Time frame: an average of one year

    total amount of oxytocin treatment in latent and active phase of labor

  4. APGAR scores

    Time frame: an average of one year

    neonatal 1 minute and 5-minute-APGAR scores

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 15, 2018
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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