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Comparative study of the effectiveness of a mobile destruction unit (Unit DU2100-M2 from MedClair™) of nitrous oxide (N2O) for low-pain delivery in the delivery room

Comparative study of the effectiveness of a mobile destruction unit (Unit DU2100-M2 from MedClair™) of nitrous oxide (N2O) for low-pain delivery in the delivery room - SMILE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00027493
Enrollment
24
Registered
2023-10-04
Start date
2022-01-24
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T41.0

Interventions

Group 1: Application of nitrous oxide, exhalation into an anesthesia gas aspiration system Group 2: Application of nitrous oxide, exhalation takes place into the mobile nitrous oxide (N2O) destruction

Sponsors

Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Willingness and ability to give consent present - Age: at least 18 years - Good understanding of German - No contraindications for nitrous oxide - Pregnancy without complications - singleton pregnancy - Expected vaginal delivery - Time: opening or expulsion phase of labor with painful, regular contractions

Exclusion criteria

Exclusion criteria: - Lack of informed consent - Multiple pregnancy - Planned cesarean delivery - Contraindications for nitrous oxide - Peridural analgesia catheter (PDA) already in situ

Design outcomes

Primary

MeasureTime frame
Effectiveness of the mobile nitrous oxide (N2O) destruction unit (results of nitrous oxide (N2O) measurements in the delivery room and time-weighted 8-hour exposure mean for delivery room staff (midwives).

Secondary

MeasureTime frame
Questionnaires (midwives, patients) about their experiences with the mobile nitrous oxide (N2O) destruction unit.

Countries

Germany

Contacts

Public ContactClemens Eichelsbacher

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Clemens.Eichelsbacher@unimedizin-mainz.de+49 6131 17 4326

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026