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

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ClinicalTrials.gov Identifier: NCT03742531
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmet Eser, 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.

Condition or disease Intervention/treatment Phase
Oxytocin Induction of Labor Drug: oxytocin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 15, 2018
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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 Name: 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 Name: synpitan




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   term pregnant women
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742531


Contacts
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Contact: ahmet eser 00905067136880 hicoice@yahoo.com
Contact: ahmet eser +902163910680 ext 1316 hicoice@yahoo.com

Locations
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Turkey
Zeynep Kamil Education and Research Hospital Recruiting
Istanbul, Turkey
Contact: ahmet eser    905067136880    hicoice@yahoo.com   
Sponsors and Collaborators
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Investigators
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Principal Investigator: ahmet eser Zeynep Kamil Education and Research Hospital
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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: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs