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Reducing Neonatal Morbidity by Discontinuing Oxytocin During the Active Phase of 1st Stage of Labor (STOPOXY)

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ClinicalTrials.gov Identifier: NCT03991091
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : February 25, 2020
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The purpose of this study is to measure the impact of a discontinuous administration of oxytocin during the active phase of the 1st stage of labor on the neonatal morbidity rate.

The investigators hypothesize that discontinuation of oxytocin in the active phase of labor (from 6 cm) in women who received oxytocin in the latent phase or for an induction (before 4 cm of dilation) could reduce neonatal morbidity.


Condition or disease Intervention/treatment Phase
Neonatal Morbidity Drug: discontinuation of oxytocin administration Drug: continuation of oxytocin administration Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Neonatal Morbidity by Discontinuing Oxytocin During the Active Phase of 1st Stage of Labor: a Multicenter Randomized Controlled Trial
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: discontinuation of oxytocin administration
Discontinuation of oxytocin administration at the beginning of the active phase of the 1st stage of labor, i.e. oxytocin infusion will be stopped beyond a cervical dilatation of 6cm
Drug: discontinuation of oxytocin administration
Discontinuation of oxytocin administration at the beginning of the active phase of the 1st stage of labor, i.e. oxytocin infusion will be stopped beyond a cervical dilatation of 6cm. In the experimental group, oxytocin can be re-started, if necessary, after 2 hours of arrest of labor.

Active Comparator: continuation of oxytocin administration
Standard care in France, i.e. when oxytocin is started during the latent phase of the 1st stage, administration of oxytocin is continued during the active 1st stage and during the 2nd stage if the fetal heart rate is reassuring.
Drug: continuation of oxytocin administration
continuation of oxytocin administration




Primary Outcome Measures :
  1. neonatal morbidity composite measure [ Time Frame: At birth ]
    Neonatal morbidity will be assessed using a composite variable defined by: an umbilical arterial pH at birth <7.10 and/or a base excess >10mmol/L and/or umbilical arterial lactates>7 mmol/L and/or a 5 minutes Apgar score <7 and/or admission in neonatal intensive care unit (NICU). This composite outcome is based on pertinent and previously published thresholds to assess neonatal acidosis[16]


Secondary Outcome Measures :
  1. umbilical cord pH<7.20 [ Time Frame: At birth ]
    umbilical arterial cord pH at birth less than 7.20

  2. umbilical cord pH<7.10 [ Time Frame: At birth ]
    umbilical arterial cord pH at birth less than 7.10

  3. umbilical cord pH<7.00 [ Time Frame: At birth ]
    umbilical arterial cord pH at birth less than 7.00

  4. Need for hypothermia [ Time Frame: At birth ]
    need for hypothermia

  5. other neonatal complications: [ Time Frame: 2 hours postpartum ]
    need of resuscitation at birth

  6. neonatal admission [ Time Frame: 2 hours postpartum ]
    transfer to neonatal care unit

  7. length of the newborn's hospital stay [ Time Frame: 0-1 month ]
    length of hospital stay

  8. mode of delivery [ Time Frame: 0-48hours ]
    cesarean rate

  9. mode of delivery [ Time Frame: 0-48hours ]
    cesarean rate for abnormal fetal heart rate

  10. mode of delivery [ Time Frame: 0-48hours ]
    instrumental vaginal delivery

  11. mode of delivery [ Time Frame: 0-48hours ]
    instrumental delivery for abnormal fetal heart rate

  12. labor duration [ Time Frame: 0-48hours ]
    labor duration (active 1st stage, passive and active 2nd stage)

  13. uterine hyper-stimulation [ Time Frame: 0-48hours ]
    uterine hyper-stimulation, defined by periods with more than 5 uterine contractions in 10 minutes during labor

  14. fetal scalp blood testing [ Time Frame: 0-48hours ]
    need for fetal scalp blood testing during labor

  15. fetal occipito-posterior position [ Time Frame: 0-48hours ]
    fetal occipito-posterior position

  16. maternal hyperthermia [ Time Frame: 0-48hours ]
    maternal fever during labor, defined by maternal temperature >38°C

  17. postpartum hemorrhage [ Time Frame: 0-48hours ]
    post-partum hemorrhage, defined by an estimated blood loss >500mL

  18. The post-partum women's satisfaction [ Time Frame: 0 5 day ]
    women's satisfaction is recorded using the "labor agentry scale". Scores on the Labor Agentry Scale range from 29 to 203, with higher scores indicating greater perceived control during childbirth.

  19. The post-partum women's satisfaction: labor agentry scale [ Time Frame: at 2 months postpartum in a survey ]
    women's satisfaction is recorded using the "labor agentry scale"[18]

  20. The post-partum women's satisfaction [ Time Frame: at 2 months postpartum in a survey ]
    Edinburgh Postnatal Depression Scale. Scores on the Edinburgh Postnatal Depression Scale rabge from 0 to 30, with higher score indicating mental health issues.

  21. The post-partum women's satisfaction [ Time Frame: at 2 months postpartum in a survey ]
    Satisfactiuon of labor and childbirth with Labor Agentry Scale

  22. The post-partum women's satisfaction [ Time Frame: at 2 months postpartum in a survey ]
    Birth experience and well being with EPDS at 2 months

  23. The post-partum women's satisfaction [ Time Frame: at 2 months postpartum in a survey ]
    Breastfeeding at 2 months



Information from the National Library of Medicine

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

Inclusion Criteria:

  • With a term (≥37 WG) pregnancy
  • Singleton pregnancy
  • Fetus in cephalic presentation
  • Women receiving oxytocin during the latent phase of the 1st stage of labor, before 4 cm of cervical dilatation, including women with an induction of labor using cervical ripening or oxytocin
  • Speaking and reading French language
  • Affiliated to social security
  • Who have signed the consent form

Exclusion Criteria:

  • Women with a scarred uterus
  • Fetus with a congenital anomaly
  • Fetal growth retardation <3rd percentile
  • Having an abnormal fetal heart rate at randomization
  • Maternal age < 18 years
  • Participating in another trial involving medication

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): NCT03991091


Contacts
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Contact: Aude Girault, MD, PhD +33 1 58 41 38 28 aude.girault@aphp.fr
Contact: Laurence Lecomte, PhD +33 1 58 41 34 78 laurence.lecomte@aphp.fr

Locations
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France
hospital Cochin; port royal Maternity unit Recruiting
Paris, France, 75014
Contact: Aude Girault, MD, PhD    +33 1 58 41 38 28    aude.girault@aphp.fr   
Contact: Camille Le Ray, MD, PhD    33 1 58 41 37 96    camille.le-ray@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Camille Le Ray, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03991091    
Other Study ID Numbers: P180581
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Multicenter
randomized
control study
Oxytocin discontinuation
Neonatal acidosis
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs