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Continuous Versus Intermittent Oxytocin for Induction of Labor: A Randomized Study

This study is currently recruiting participants.
Verified December 2016 by Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02859571
First Posted: August 9, 2016
Last Update Posted: December 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
  Purpose
This study evaluates continuous oxytocin versus intermittent oxytocin for induction of labor at term. Half of participants will be taken continuous oxytocin, while the other half will be taken intermittent oxytocin.

Condition Intervention Phase
Intemittant, Continue, Oxytocin Drug: Oxytocin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital:

Primary Outcome Measures:
  • induction-to-delivery time [ Time Frame: intraoperative ]

Estimated Enrollment: 200
Study Start Date: August 2016
Estimated Study Completion Date: January 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continuous oxytocin
oxytocin will be used at a starting dose of 1-2 mIU/min and the dose will be increased by 2 mIU/min at every 15 minutes until regular contractions will be obtained at a rate of 3-5 contractions in a 10-minute period. The maximum dose of oxytocin will 40 mIU/min and oxytocin will be administered until delivery.
Drug: Oxytocin
Experimental: intermittent oxytocin
oxytocin will be discontinued when cervical dilation will 5 cm and 2 hours after discontinuation oxytocin will be reused at a starting dose of 1-2 mIU/min and will be increased as the same protocol will be used for continuation oxytocin group.
Drug: Oxytocin

Detailed Description:
In the continuous oxytocin group, traditional treatment of oxytocin used at a starting dose of 1-2 mIU/min and the dose was increased by 2 mIU/min at every 15 minutes until regular contractions obtained at a rate of 3-5 contractions in a 10-minute period. The maximum dose of oxytocin was 40 mIU/min and oxytocin was administered until delivery. In the intermittent group, oxytocin was discontinued when cervical dilation was 5 cm and 2 hours after discontinuation oxytocin was reused at a starting dose of 1-2 mIU/min and was increased as the same protocol used for continuation oxytocin group.
  Eligibility

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • singleton pregnancy,
  • 37≤ weeks of gestational age ,
  • vertex presentation,
  • women with cervical dilation 3 cm
  • no contraindication to vaginal delivery.

Exclusion Criteria:

  • fetal malpresentation,
  • multifetal pregnancy,
  • more than three contractions in 10 minutes,
  • contraindications to oxytocin,
  • a category II or III fetal heart rate pattern,
  • fetal anomaly,
  • fetal demise
  • women with immediate delivery indications
  Contacts and Locations
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): NCT02859571


Contacts
Contact: evrim bostanci ergen, M.D. 505 617 96 23 evrimbostanc6666@gmail.com

Locations
Turkey
Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology Recruiting
Istanbul, Turkey, 34000
Contact: ahmet eser, medical doctor    +905056179623    drahmeteser@gmail.com   
Sponsors and Collaborators
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Investigators
Principal Investigator: evrim bostanci ergen Zeynep Kamil Maternity and Pediatric Research and Training Hospital
  More Information

Publications:
Responsible Party: Ahmet Eser, medical doctor, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
ClinicalTrials.gov Identifier: NCT02859571     History of Changes
Other Study ID Numbers: 152
First Submitted: August 4, 2016
First Posted: August 9, 2016
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs