NCT04346524

Brief Summary

Dysbiosis is associated with an increased risk of preeclampsia during pregnancy. The microbiome differs between those with and without type 1 diabetes and the cause of type 1 diabetes has been associated with dysbiosis. Increased knowledge of the microbiome and its variation, depending on the state of health during pregnancies complicated with type 1 diabetes, could in the future lead to preventive care and treatments during these pregnancies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

2.7 years

First QC Date

April 9, 2020

Last Update Submit

November 21, 2021

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesMicrobiomamaternal and fetal pregnacy outcomes

Outcome Measures

Primary Outcomes (1)

  • Maternal complications during pregnancy

    The frequency of Preeklampsia, hypertension and other pregnancy complications

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Fetal complications during pregnancy

    through study completion, an average of 1 year

Study Arms (1)

microbiome sampling

pregnant women with type 1 diabetes

Other: sampling of microbiome

Interventions

sampling of microbiomeOTHER

women will sample from vagina, feces, and saliva during pregnancy

microbiome sampling

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women with type 1 diabetes
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pregnant women with type 1 diabetes

You may qualify if:

  • Pregnant Women with type 1 diabetes
  • Included as a patient at women's clinic Soderhospital in Stockholm
  • Acceptant to sample her microbiome during pregnancy

You may not qualify if:

  • Women without type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eva Wiberg-Itzel

Danderyd, Sverige, 18239, Sweden

NOT YET RECRUITING

Eva Wiberg-Itzel

Stockholm, 18239, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Eva Wiberg-Itzel, PhD

    Karolinska Institute Sodersjukhuset Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Wiberg-Itzel, PhD

CONTACT

+46708775346eva.itzel@telia.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 15, 2020

Study Start

April 1, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations

SE(2)