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Confidential: for Review Only Continued Versus Discontinued Oxytocin Stimulation in the Active Phase of Labour (CONDISOX)- a Double-Blind Randomised Controlled Trial

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Confidential: for Review Only Continued Versus Discontinued Oxytocin Stimulation in the Active Phase of Labour (CONDISOX)- a Double-Blind Randomised Controlled Trial BMJ Confidential: For Review Only Continued versus discontinued oxytocin stimulation in the active phase of labour (CONDISOX)- A double-blind randomised controlled trial Journal: BMJ Manuscript ID BMJ-2020-063027 Article Type: Research BMJ Journal: BMJ Date Submitted by the 09-Nov-2020 Author: Complete List of Authors: Boie, Sidsel; Randers Regional Hospital, Obstetrics and Gynaecology Glavind, Julie; Aarhus University Hospital, Obstetrics and Gynaecology Uldbjerg, Niels; Aarhus University Hospital, Obstetrics and Gynecology Steer, Philip; Imperial College London, Academic Department of Obstetrics and Gynaecology Bothazi, Attila; Aalborg University Hospital, Obstetrics and Gynaecology Sundtoft, Iben ; Hospitalsenheden Vest, Obstetrics and Gynaecology Bakker, Jannet; Amsterdam UMC Location AMC, Obstetrics and Gynaecology Van der Post, Joris; Amsterdam UMC Location AMC, Obstetrics and Gynaecology Renault, Kristina; Rigshospitalet, Obstetrics and Gynaecology Huusom, Lene; Hvidovre Hospital, Obstetrics and Gynaecology Hvidman, Lone; Aarhus University Hospital, Obstetrics and Gynaecology Rask, Maja; Odense University Hospital, Obstetrics and Gynaecology Khalil, Mohammed; Sygehus Lillebalt Kolding Sygehus, Obstetrics and Gynaecology Møller, Nini; Nordsjaellands Hospital, Obstetrics and Gynaecology Greve, Tine; Hvidovre Hospital, Obstetrics and Gynaecology Bor, Pinar; Randers Regional Hospital, Obstetrics and Gynaecology induction of labour, oxytocin, discontinuation, Caesarean section, active Keywords: phase of labour, uterine tachysystole https://mc.manuscriptcentral.com/bmj Page 1 of 44 BMJ CONDISOX paper 2020-11-08 1 2 3 Continued versus discontinued oxytocin stimulation in the active phase of labour (CONDISOX)- A double-blind 4 randomised controlled trial 5 6 Sidsel Boie1, Julie Glavind2, Niels Uldbjerg2, Philip J Steer3, CONDISOX trial group*, Pinar Bor1 7 8 *The following are members of CONDISOX trial group: 9 Attila Bothazi4, Iben Sundtoft5, Jannet Bakker6, Joris Van der Post6, Kristina Martha Renault7, Lene Drasbek Huusom8, 10 Lone Hvidman2, Maja Thode Rask9, Mohammed Khalil10, Nini Møller11, Tine Greve8 11 12 Affiliations Confidential: For Review Only 13 1. Department of Obstetrics and Gynaecology, Randers Regional Hospital, Randers, Denmark 14 2. Department of Obstetrics and Gynaecology, Aarhus University Hospital, Aarhus, Denmark 15 3. Academic Department of Obstetrics and Gynaecology, Chelsea and Westminster Hospital, Imperial College London, 16 London, UK 17 4. Department of Obstetrics and Gynaecology, Aalborg University Hospital, Aalborg, Denmark 18 5. Department of Obstetrics and Gynaecology, Herning Regional Hospital, Herning, Denmark 19 6. Department of Obstetrics and Gynaecology, Amsterdam UMC, Amsterdam University Hospital, Amsterdam, The 20 Netherlands. 21 7. Department of Obstetrics and Gynaecology, Juliane Marie Centre, Copenhagen University Hospital, Rigshospitalet, 22 Copenhagen, Denmark 23 8. Department of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre Hospital, Hvidovre, 24 Denmark 25 9. Department of Obstetrics and Gynaecology, Odense University Hospital, Odense, Denmark 26 10. Department of Obstetrics and Gynaecology, Lillebaelt Hospital, Kolding, Denmark 27 11. Department of Obstetrics and Gynaecology, Copenhagen University Hospital, Nordsjaelland Hospital, Hilleroed, 28 Denmark 29 30 Corresponding author: 31 Sidsel Boie, MD 32 Department of Obstetrics and Gynaecology 33 Randers Regionalhospital 34 Denmark 35 +45 60 63 68 35 36 [email protected] 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Page 1 https://mc.manuscriptcentral.com/bmj BMJ Page 2 of 44 CONDISOX paper 2020-11-08 1 2 3 Abstract 4 Objective 5 Small studies have suggested that discontinuing oxytocin stimulation in the active phase of induced labour is associated 6 7 with lower caesarean section rates. 8 Design: 9 10 An international multicentre double-blind trial. 11 Setting 12 Confidential: For Review Only The trial was conducted in one Dutch and nine Danish Hospitals between April 8, 2016 to June 30, 2020. 13 14 Participants: 15 The population was women stimulated with intravenous oxytocin infusion during the latent phase of induced labour. 16 17 Intervention: 18 Women were randomly assigned to have their oxytocin stimulation discontinued or continued in the active phase of 19 20 labour. 21 Main outcome measure: 22 Delivery by caesarean section. 23 24 Results: 25 A total of 607 women were assigned to discontinuation and 593 to continuation of the oxytocin infusion. The rates of 26 27 caesarean section were 16.6 % in the discontinued group and 14.2 % in the continued group (Relative Risk, 1.17; 95% 28 confidence interval [CI], 0.90 to 1.53). 29 30 31 Discontinuation was associated with longer duration of labour (median from randomisation to delivery 282 versus 201 32 33 minutes, p<0.001), a reduced risk of hyperstimulation (3.7% vs 12.9%, p<0.001), a reduced risk of fetal heart rate 34 abnormalities (27.9% vs 40.8%, p<0.001), and similar rates of other adverse maternal and neonatal outcomes. 35 36 37 Conclusions: 38 In a setting where monitoring of the fetal condition and the uterine contractions can be guaranteed routinely 39 40 discontinuing oxytocin in the active phase of induced labour is neither beneficial nor harmful. 41 42 43 Trial registration: ClinicalTrials.gov registration number NCT02553226 44 Keywords: Induction of labour, oxytocin, discontinuation, Caesarean section, active phase of labour, uterine 45 46 tachysystole 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Page 2 https://mc.manuscriptcentral.com/bmj Page 3 of 44 BMJ CONDISOX paper 2020-11-08 1 2 3 Funding 4 Randers Regional Hospital Research Fund. Aarhus University. Health Research Fund of Central Denmark Region. 5 Dagmar Marshall Foundation. The Danish Regions Medical Foundation. Aase and Ejnar Danielsen Foundation. The 6 7 A.P. Moeller Foundation for the Advancement of Medical Science. The Soren Segels and Johanne Wiibroe Segels 8 Research Fund. The funders had no role in the design of the study, the data collection, the data analysis, interpretation 9 10 of data, nor in writing the manuscript. 11 12 ContributorsConfidential: For Review Only 13 14 SB, PB, JG, NU, and PS conceived and designed the study. The members of TSC and DMEC contributed to the design. 15 SB, PB, JG, NU, JB, AB, LH, IS, MK, MR, KR, LDH, TG, and NM performed the study. Representatives of each 16 17 centre entered the data, and the data was crosschecked by Good Clinical Practices monitors at all centres. SB did the 18 statistical analysis, overviewed by an external statistician and PS. Data interpretation was done by SB, PB, JG, NU, and 19 PS. SB drafted the original manuscript with major contributions from PB, JG, NU and PS. All authors reviewed and 20 21 revised the manuscript. All authors read and approved the final manuscript. Furthermore, all authors have agreed to be 22 personally accountable for their contributions and to ensure that questions related to the accuracy or integrity of any part 23 24 of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and 25 the resolution documented in the literature. 26 27 28 Acknowledgement 29 We wish to thank all the families who participated in this trial, the dedicated staff from all participating departments. 30 31 Furthermore, we want to acknowledge the valuable contributions from each member of the Trial Steering Committee; 32 Jim Thornton (chair), Thomas Bergholt, Wessel Ganzevoort, and Jens Fuglsang. Each member of the Data Monitoring 33 34 and Ethics Committee consisting of Lone Krebs (chair), Gorm Greisen and Martin Johansen should also be personally 35 acknowledged for their contributions. 36 37 38 Declaration of interest 39 40 All authors have completed the ICMJE uniform disclosure form and declare no financial relationships with any 41 organisations that might have an interest in the submitted work in the previous three years and no other relationships or 42 activities that could have influenced the submitted work. 43 44 45 Data availability 46 47 Due to Danish legislation data will only be available after approval of Danish Data Protection Agency and with a signed 48 access agreement. 49 50 51 Abbreviations 52 CEQ Childbirth Experience Questionnaire 53 54 DMEC Data Monitoring and Ethics Committee 55 GCP Good Clinical Practice 56 57 IOL Induction of labour 58 IU International Unit 59 60 Page 3 https://mc.manuscriptcentral.com/bmj BMJ Page 4 of 44 CONDISOX paper 2020-11-08 1 2 3 NICU Neonatal Intensive Care Unit 4 PROM Prelabour Rupture of Membranes 5 REDCap Research Electronic Data Capture 6 7 TSC Trial Steering Committee 8 9 10 11 12 Confidential: For Review Only 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Page 4 https://mc.manuscriptcentral.com/bmj Page 5 of 44 BMJ CONDISOX paper 2020-11-08 1 2 3 Summary boxes 4 What is already known on this topic 5 6 Four meta-analyses suggest that once a woman is in active labour, the labour process continues even if oxytocin 7 stimulation is stopped, and results in a lower risk for caesarean section. 8 9 The 2018 Cochrane review questions the quality of previous studies due to design limitations and judge many of the 10 trials to be at either high or unclear risk of bias across a number of 'risk of bias' domains. 11 12 Confidential: For Review Only 13 What this study adds 14 This is the largest, truly double-blinded trial on discontinuation of oxytocin stimulation in the active phase of induced 15 16 labour. 17 In a setting where close monitoring of the fetal condition can be guaranteed and proper action is taken in case of 18 19 hyperstimulation, routinely discontinuing oxytocin in the active phase of induced labour is neither beneficial nor 20 harmful. 21 22 In case of fetal heart rate abnormalities or uterine hyperstimulation, turning off the oxytocin is an important first step to 23 safeguard the fetus and mothers, and birth attendants can be reassured that this will not significantly increase the 24 likelihood of caesarean section, or adversely affect other outcome measures.
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