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

Overview

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.

Full Title of Study: “Does Induction Dosage in Latent Phase Affect Active Phase of Labor?A Randomized Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 15, 2019

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.

Interventions

  • Drug: oxytocin
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: low dose group
    • 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.
  • Active Comparator: high dose group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • need for oxytocin retreatment
    • Time Frame: an average of one year
    • need for oxytocin retreatment due to inadequate uterine contractions and labor arrest

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

term pregnant women

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Zeynep Kamil Maternity and Pediatric Research and Training Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmet Eser, principal investigator – Zeynep Kamil Maternity and Pediatric Research and Training Hospital
  • Overall Official(s)
    • ahmet eser, Principal Investigator, Zeynep Kamil Education and Research Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.