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

NCT02859571 | Unknown Phase 2 DMC

• 1 other identifier: 152
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intemittant, Continue, Oxytocin

Outcome Measures

Primary Outcomes (1)

• induction-to-delivery time

  intraoperative

Study Arms (2)

Continuous oxytocin

ACTIVE COMPARATOR

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

intermittent oxytocin

EXPERIMENTAL

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

Interventions

Oxytocin DRUG

Continuous oxytocin; intermittent oxytocin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeynep Kamil Maternity and Pediatric Research and Training Hospital: lead

Study Sites (1)

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

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 26309128 BACKGROUND

• 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.

  PMID: 24646336 BACKGROUND

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• evrim bostanci ergen

  Zeynep Kamil Maternity and Pediatric Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

evrim bostanci ergen, M.D.

CONTACT

505 617 96 23; evrimbostanc6666@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 9, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: December 8, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)