Clincosm LogoSign in Get a demo

O2P2: Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT03581214
Collaborator
(none)
212
Enrollment
1
Location
2
Arms
58.5
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Approximately 2/3 of laboring women receive supplemental oxygen (O2) in an attempt to reverse perceived fetal hypoxia on electronic fetal monitoring (EFM). O2 supplementation is most commonly used in patients with Category II EFM, a class of EFM patterns designed in part to identify fetal acidemia. This liberal use of O2 in laboring patients is concerning because hyperoxygenation in infants is associated with adverse outcomes including retinopathy and abnormal neurodevelopment. Furthermore, excess O2 exposure is linked to free radical generation and subsequent oxidative cell damage. This calls for a closer look at the safety of intrauterine O2 exposure. The proposed project explores potential mechanisms for harm with maternal O2 supplementation in laboring patients with Category II EFM. Specifically, this project will determine the effect of O2, compared to room air (RA), on umbilical cord and maternal levels of malondialdehyde (MDA) and 4-hydroxynonenal (4-HNE), markers of free radical-induced oxidative stress. The study will also explore the correlation between urinary and blood markers of oxidative stress. Banked specimens will be used to investigate the potential effect of peripartum O2 exposure on placental oxidative stress in the future.

Condition or Disease Intervention/Treatment Phase
  • Other: No oxygen
  • Other: Oxygen
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
212 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
Actual Study Start Date :
Jul 15, 2018
Anticipated Primary Completion Date :
Jul 28, 2022
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Room air

Room air (no mask)

Other: No oxygen
No facemask, room air only
Other Names:
  • Room air

    		•
    Placebo Comparator: Oxygen

    10L/min Oxygen by facemask

    Other: Oxygen
    10Liters/minute oxygen by facemask

    Outcome Measures

    Primary Outcome Measures

    1. Umbilical artery malondialdehyde [At delivery]

    2. Umbilical artery 4-hydroxynonenal [At delivery]

    3. Maternal malondialdehyde [Within 1 hour of delivery]

    4. Maternal 4-hydroxynonenal [Within 1 hour of delivery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Singleton

    • Gestational age ≥37 weeks

    • Spontaneous labor or induction of labor

    • English speaking

    • Ability to give informed consent

    Exclusion Criteria:

    • Major fetal anomaly

    • Multiple gestation

    • Category III electronic fetal monitoring

    • Maternal hypoxia

    • Preeclampsia

    • Intrauterine growth restriction

    • Pregestational diabetes

    • Tobacco use

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barnes Jewish Hospital Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nandini Raghuraman, Assistant Professor, Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT03581214
    Other Study ID Numbers:
    • 201805045
    First Posted:
    Jul 10, 2018
    Last Update Posted:
    Jul 23, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 23, 2021