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

December 6, 2016 updated by: Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34000
        • Recruiting
        • Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
induction-to-delivery time
Time Frame: intraoperative
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Investigators

  • Principal Investigator: evrim bostanci ergen, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Estimate)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intemittant, Continue, Oxytocin

Clinical Trials on Oxytocin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe