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

NCT ID: NCT02859571

Last Updated: 2016-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intemittant, Continue, Oxytocin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Interventions

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Oxytocin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Eser

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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evrim bostanci ergen

Role: PRINCIPAL_INVESTIGATOR

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Locations

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Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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evrim bostanci ergen, M.D.

Role: CONTACT

Phone: 505 617 96 23

Email: [email protected]

Facility Contacts

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ahmet eser, medical doctor

Role: primary

References

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Bor P, Ledertoug S, Boie S, Knoblauch NO, Stornes I. Continuation versus discontinuation of oxytocin infusion during the active phase of labour: a randomised controlled trial. BJOG. 2016 Jan;123(1):129-35. doi: 10.1111/1471-0528.13589. Epub 2015 Aug 26.

Reference Type BACKGROUND
PMID: 26309128 (View on PubMed)

Ozturk FH, Yilmaz SS, Yalvac S, Kandemir O. Effect of oxytocin discontinuation during the active phase of labor. J Matern Fetal Neonatal Med. 2015 Jan;28(2):196-8. doi: 10.3109/14767058.2014.906573. Epub 2014 Apr 9.

Reference Type BACKGROUND
PMID: 24646336 (View on PubMed)

Other Identifiers

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152

Identifier Type: -

Identifier Source: org_study_id