Impact of Anesthetic Environment the Sex Ratio of the Chi... | NCT04532502

Studies
Impact of Anesthetic Environment the Sex Ratio of the Children of Female Assistants

NCT04532502

Sponsor

University of Liege

Status

Completed

Last Update Posted

Dec 3, 2021Actual

Enrollment

143Actual

Phase

Not provided

Conditions

Anesthesia, General
Anesthetics Adverse Reaction

Interventions

Anesthetics, Inhalation

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2, 2021Actual

Primary Completion Date

Dec 2, 2021Actual

Completion Date

Dec 2, 2021Actual

First Submitted Date

Aug 25, 2020

First Submission Date that Met QC Criteria

Aug 25, 2020

First Posted Date

Aug 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2021

Last Update Posted Date

Dec 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aims of this multi center retrospective study was to determine:

whether the sex ratio of the offspring of female assistants in anesthesia-resuscitation differs from that of the population at large
whether the assistants' work environment at the time of their offspring's conception influences the sex of their offspring

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		All female assistants in anesthesia	Drug: Anesthetics, Inhalation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anesthetics, Inhalation	Drug	Work environmental exposure	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Offspring sex ratio	Offspring sex ratio of female anesthesia assistants will be recorded	5 years (duration of anesthesia training)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female assistants in anesthesia-resuscitation in the Wallonia-Brussels Federation (Belgium) who conceived one or more children in the course of their training between 2009 and 2019 and who delivered before the end of 2019 (cut-off: midnight on 31 December 2019)

Exclusion Criteria:

Male assistants in anesthesia-resuscitation
Female assistants in anesthesia-resuscitation who trained before 2009 or after 2019.
Female assistants in anesthesia-resuscitation who relied on medically assisted reproduction.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The anesthesia department of the three French-speaking universities in Belgium wimp e-mail a questionnaire to all female assistants in anesthesia-resuscitation via a system similar to Survey Monkey. The data will be completely anonymized through those of such a system.

Reminder will be e-mailed 1 and 3 months after the questionnaire is sent out. Filling the questionnaire will be equated with consent

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe J Van der Linden, MD	CHU Brugmann, Free University of Brussels, Belgium	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ULiege		Liège		4000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23878446	Background	Gupta D, Kaminski E, McKelvey G, Wang H. Firstborn offspring sex ratio is skewed towards female offspring in anesthesia care providers: A questionnaire-based nationwide study from United States. J Anaesthesiol Clin Pharmacol. 2013 Apr;29(2):221-7. doi: 10.4103/0970-9185.111728.
	Background	Leroy C, Daelemans C, Debauche C, Van Leeuw V. Santé périnatale en Wallonie - année 2017, Centre d'Epidémiologie Périnatale 2019.

ID	Term
D018681	Anesthetics, General
D000777	Anesthetics
D002492	Central Nervous System Depressants
D045505	Physiological Effects of Drugs