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Continued Versus Discontinued Oxytocin Stimulation of Labour (CONDISOX)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02553226
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : August 28, 2020
Sponsor:
Collaborators:
Randers Regional Hospital
Aarhus University Hospital
Kolding Sygehus
Aalborg University Hospital
Herning Hospital
Rigshospitalet, Denmark
University of Amsterdam
Hillerod Hospital, Denmark
Odense University Hospital
Hvidovre University Hospital
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Adverse Reaction to Oxytocin Drug: Oxytocin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Continued Versus Discontinued Oxytocin Stimulation of Labour in a Double-blind Randomised Controlled Trial
Study Start Date : April 2016
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Oxytocin

Arm Intervention/treatment
Active Comparator: Continued group
Recieve routine treatment with oxytocin according to the danish national guidelines.
Drug: Oxytocin
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.
Other Name: syntocinon

Placebo Comparator: discontinued group (placebo)
The routine treatment with oxytocin will be discontinued and replaced with isotonic saline, when the active phase of labour is established.
Drug: Placebo
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.
Other Name: Isotonic saline




Primary Outcome Measures :
  1. Caesarean section [ Time Frame: labour ]
    Frequency of acute performed caesarean sections


Secondary Outcome Measures :
  1. Instrumental delivery [ Time Frame: 0-48 hours ]
    use of vacuum extraction or forceps for delivery

  2. Birth experience [ Time Frame: 4 weeks postpartum ]
    Childbirth Experience Questionaire (CEQ)

  3. Breastfeeding [ Time Frame: 0-6months ]
    Time to established feeding and duration of exclusive breastfeeding.

  4. Duration of the active phase of labour [ Time Frame: 0-48 hours ]
    Maternal outcome

  5. Total duration of labour [ Time Frame: 0-48 hours ]
    (from initiation time of stimulation with Syntocinon until delivery)

  6. Uterine tachysystoli [ Time Frame: 0-48 hours ]
    Parturition will be monitored with continous CTG

  7. Uterine hyperstimulation [ Time Frame: 0-48 hours ]
    Parturition will be monitored with continous CTG

  8. Use of epidural analgesia [ Time Frame: 0-48 hours ]
  9. Dose and duration of oxytocin infusion [ Time Frame: 0-48 hours ]
  10. Use of episiotomy [ Time Frame: 0-48 hours ]
  11. Rupture of the anal sphincter [ Time Frame: 0-48 hours ]
  12. Uterine rupture [ Time Frame: 0-48 hours ]
  13. Volume of blood loss at delivery and postpartum [ Time Frame: 0-48 hours ]
  14. Need for evacuation of retained products of conception [ Time Frame: 0-48 hours ]
  15. Maternal use of antibiotics during labour [ Time Frame: 0-48 hours ]
  16. Maternal readmission [ Time Frame: 0-168 hours ]
  17. Retention of urine [ Time Frame: 0-48 hours ]
    requiring catheterisation

  18. Vaginal explorations [ Time Frame: 0-48 hours ]
    number

  19. Cardiotocogram (CTG) classification [ Time Frame: 0-48 hours ]
    Parturition will be monitored with continous CTG. Suspicious, pathologic or terminal CTG will be registered.

  20. Fetal scalp pH values or Fetal scalp lactate [ Time Frame: 0-48 hours ]
  21. Apgar score at 1 and 5 minutes [ Time Frame: 0-48 hours ]
  22. Umbilical cord arterial pH [ Time Frame: 0-48 hours ]
  23. Neonatal use of antibiotics - postpartum [ Time Frame: 0-48 hours ]
  24. Neonatal hyperbilirubinaemia [ Time Frame: 0-48 hours ]
    High values of bilirubinaemi, which leads to treatment, will be registered

  25. Neonatal admission [ Time Frame: 0-48 hours ]
    Admission in Neonatal Intensive Care Unit (NICU)

  26. Need for resuscitation/ventilation of the newborn [ Time Frame: 0-48 hours ]
    (bag, mask, CPAP, and/or intubation, time to onset of spontaneous ventilation)

  27. Neonatal death [ Time Frame: 0-7 days ]
  28. Time of birth of placenta [ Time Frame: 0-2 hours ]
  29. Cause of maternal readmission [ Time Frame: 0-7 days ]
    Suspected infection, Endometritis proven with culture, Urinary tract infection treated with antibiotics, Wound infection treated with abtibiotics, Bowel obstruction, Pneumonia, Trombo-embolic complications, Eclampsia, HELLP, Admission due to child, no maternal reason



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.


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): NCT02553226


Locations
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Denmark
Aarhus University Hospital
AArhus, Aarhus N, Denmark, 8210
Aalborg University Hospital
Aalborg, Denmark, 9000
Rigshospitalet
Copenhagen, Denmark
Regionshospitalet Herning
Herning, Denmark
Nordsjællandshospital
Hillerød, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Sygehus LIllebælt
Kolding, Denmark, 6000
Odense University Hospital
Odense, Denmark
Department of Gynecology and Obstetrics
Randers, Denmark, 8930
Netherlands
Academic Medical Center
Amsterdam, Amsterdam-Zuidoost, Netherlands, 1105
Sponsors and Collaborators
University of Aarhus
Randers Regional Hospital
Aarhus University Hospital
Kolding Sygehus
Aalborg University Hospital
Herning Hospital
Rigshospitalet, Denmark
University of Amsterdam
Hillerod Hospital, Denmark
Odense University Hospital
Hvidovre University Hospital
Investigators
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Principal Investigator: 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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02553226    
Other Study ID Numbers: 01102015
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

The trial is GCP monitored by the GCP unit of Aarhus University Hospital, Odense University Hospital, Copenhagen University and The GCP unit at the AMC

Members of the Data Monitoring Committee:

Chair: Lone Krebs (Obstetrician) Member: Gorm Greisen (Pediatrician) Member: Martin Johansen (Statistician)

Members of the Trial Steering Committee:

Chair: Jim Thornton Member: Thomas bergholt Member: Jens Fuglsang Member: Wessel Ganzevoort

Keywords provided by University of Aarhus:
Active phase of labour
Discontinuation
Caesarean section
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs