Alcohol Use During Pregnancy in Finland According to Meco... | NCT04918043

Studies
Alcohol Use During Pregnancy in Finland According to Meconium Samples

NCT04918043

Sponsor

Hanna Kahila

Status

Unknown status

Last Update Posted

Jun 8, 2021Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Not provided

Countries

Not provided

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

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Estimated

Primary Completion Date

Aug 30, 2021Estimated

Completion Date

Aug 30, 2021Estimated

First Submitted Date

May 30, 2021

First Submission Date that Met QC Criteria

May 30, 2021

First Posted Date

Jun 8, 2021Actual

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

May 30, 2021

Last Update Posted Date

Jun 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hanna Kahila, MD, Helsinki University Central HospitalSponsor-Investigator

Lead Sponsor

Hanna KahilaOTHER

Collaborators

Name	Class
Helsinki University Central Hospital	OTHER
Lastentautien tutkimussäätiö	UNKNOWN

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

Meconium samples are collected anonymously from newborns in Helsinki University Hospital maternity ward. The study tries to to find how many women continue to use alcohol during the second half of the pregnancy. Meconium samples are tested for ethylglucuronide (EtG), a metabolite of ethanol, that accumulates in the meconium. Altogether 1000 samples are taken. The sample results are compared to anonymously answered questionnaire about alcohol use.

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

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HUCS, NKL		Newborns and their mothers at the Helsinki University Central Hospital maternity ward.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EtG	The meconium samples from newborns are tested for ethyl glucuronide using LC-MS/MS mass spectrometry.	Once

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

newborn baby

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Days

Standard Ages

Child

Study Population

The study population consists of the newborn babies that are born at the Helsinki University Central hospital maternity ward.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mikko Koivu-Jolma	Contact	+358414873836		mikko.koivu-jolma@helsinki.fi

Overall Officials

Name	Affiliation	Role
Hanna Kahila, MD	HUCS	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All anonymous IPD will be shared with the modelling source code.

Types

Informed Consent Form (ICF)
Analytic Code

Time Frame

6 months after the publication

Access Criteria

Scientific study, policy making

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D063647	Fetal Alcohol Spectrum Disorders

Ancestor Terms

ID	Term
D005315	Fetal Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided