Clincosm LogoSign in Get a demo

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

Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03742531
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
11.5
Actual Duration (Months)
26
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Does Induction Dosage in Latent Phase Affect Active Phase of Labor?A Randomized Study
Actual Study Start Date :
Dec 15, 2018
Actual Primary Completion Date :
Jun 15, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

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.
Other Names:
  • synpitan

    		•
    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.

    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.
    Other Names:
  • synpitan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. need for oxytocin retreatment [an average of one year]

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

    Secondary Outcome Measures

    1. length of active phase [an average of one year]

      duration of acive phase of labor

    2. ratio of caesarean section [an average of one year]

      caesaraen section rate in total delivery

    3. total oxytocin dose [an average of one year]

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

    4. APGAR scores [an average of one year]

      neonatal 1 minute and 5-minute-APGAR scores

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zeynep Kamil Education and Research Hospital Istanbul Turkey

    Sponsors and Collaborators

    • Zeynep Kamil Maternity and Pediatric Research and Training Hospital

    Investigators

    • Principal Investigator: ahmet eser, Zeynep Kamil Education and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmet Eser, principal investigator, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
    ClinicalTrials.gov Identifier:
    NCT03742531
    Other Study ID Numbers:
    • 50
    First Posted:
    Nov 15, 2018
    Last Update Posted:
    Jan 20, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Oxytocin

    Study Results

    No Results Posted as of Jan 20, 2021