Continued Versus Discontinued Oxytocin Stimulation of Labour

NCT02553226 | Completed Phase 4 DMC

• 1 other identifier: 01102015
• Study Type: interventional
• Target: 1,200
• Locations: 2 countries
• Sites: 10

Brief Summary

Background: The proposed study will investigate the effect of Syntocinon® (synthetic oxytocin) to induce labour. The hypothesis to be studied is that once the active phase of labour has commenced, Syntocinon® can be discontinued and the labour process will continue. Design: Double-blind randomised controlled multicentre trial Setting: Aarhus University Hospital, Denmark and Regional Hospital of Randers, Denmark Population: 1200 women (600 in each group) stimulated in the latent phase of labour with oxytocin for induction Methods: The Syntocinon® infusion will be replaced with either continuous isotonic saline (placebo) or Syntocinon® infusion (control group), when the active phase of labour is reached. Main outcome measures: Caesarean section (primary outcome), tachysystole, neonatal asphyxia, birth experience Perspective: Syntocinon® is on the list high-alert medications and associated with complications for mother and child during labour. Reducing the duration of stimulation during labour may lower the number of asphyxial sequelae and the number of caesarean sections.

Conditions

Adverse Reaction to Oxytocin

Keywords

Active phase of labour; Discontinuation; Caesarean section

Outcome Measures

Primary Outcomes (1)

• Caesarean section

  Frequency of acute performed caesarean sections

  labour

Secondary Outcomes (29)

• Instrumental delivery

  0-48 hours

• Birth experience

  4 weeks postpartum

• Breastfeeding

  0-6months

• Duration of the active phase of labour

  0-48 hours

• Total duration of labour

  0-48 hours

Study Arms (2)

Continued group

ACTIVE COMPARATOR

Recieve routine treatment with oxytocin according to the danish national guidelines.

Drug: Oxytocin

discontinued group (placebo)

PLACEBO COMPARATOR

The routine treatment with oxytocin will be discontinued and replaced with isotonic saline, when the active phase of labour is established.

Drug: Placebo

Interventions

Oxytocin DRUG

Both arms will initially receive routine treatment with oxytocin according to national guidelines. When active phase of labour is established both arms will have their infusion-set changed for a blinded infusion-set.

Also known as: syntocinon

Continued group

Placebo DRUG

Both arms will initially receive routine treatment with oxytocin according to national guidelines. When active phase of labour is established both arms will have their infusion-set changed for a blinded infusion-set.

Also known as: Isotonic saline

discontinued group (placebo)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women stimulated with Syntocinon® infusion for induction of labour (with or without cervical priming by prostaglandin)

You may not qualify if:

• Unable to read and understand the Danish language or to give informed consent
• Cervical dilatation \> 4 cm
• Non-cephalic presentation
• Multiple gestation
• Pathological fetal heart rate pattern (cardiotocogram, CTG) before Syntocinon® initiation
• Fetal weight estimation \> 4500 g (clinical or ultrasonic)
• Subject declines participation
• Gestational age less than 37 completed weeks
• Definition: Stimulation with Syntocinon® following Premature Rupture of membranes (PROM) is induction of labour if there is no cervical change prior to starting the infusion, whereas stimulation with Syntocinon after PROM but following the establishment of significant cervical change is augmentation.

Sponsors & Collaborators

• University of Aarhus: lead
• Randers Regional Hospital: collaborator
• Aarhus University Hospital: collaborator
• Kolding Sygehus: collaborator
• Aalborg University Hospital: collaborator
• Herning Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• University of Amsterdam: collaborator
• Hillerod Hospital, Denmark: collaborator
• Odense University Hospital: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (10)

Aarhus University Hospital

Aarhus, Aarhus N, 8210, Denmark

Location

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Regionshospitalet Herning

Herning, Denmark

Location

Nordsjællandshospital

Hillerød, Denmark

Location

Hvidovre Hospital

Hvidovre, Denmark

Location

Sygehus LIllebælt

Kolding, 6000, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Department of Gynecology and Obstetrics

Randers, 8930, Denmark

Location

Academic Medical Center

Amsterdam, Amsterdam-Zuidoost, 1105, Netherlands

Location

Related Publications (2)

• Boie S, Glavind J, Uldbjerg N, Steer PJ, Bor P; CONDISOX trial group. Continued versus discontinued oxytocin stimulation in the active phase of labour (CONDISOX): double blind randomised controlled trial. BMJ. 2021 Apr 14;373:n716. doi: 10.1136/bmj.n716.

  PMID: 33853878 DERIVED

• Boie S, Glavind J, Uldbjerg N, Bakker JJH, van der Post JAM, Steer PJ, Bor P. CONDISOX- continued versus discontinued oxytocin stimulation of induced labour in a double-blind randomised controlled trial. BMC Pregnancy Childbirth. 2019 Sep 2;19(1):320. doi: 10.1186/s12884-019-2461-x.

  PMID: 31477047 DERIVED

MeSH Terms

Interventions

Oxytocin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Niels Uldbjerg, DMSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Pinar Bor, PhD

  Regionalhospital Randers

  PRINCIPAL INVESTIGATOR

• Julie Glavind, PhD

  Regionalhospital Randers

  PRINCIPAL INVESTIGATOR

• Philip Steer, BSc

  Imperial College, London, England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2015
• First Posted: September 17, 2015
• Study Start: April 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 28, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); DK (9)