Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-04-01
2022-12-30
Brief Summary
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Detailed Description
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All pregnancies complicated with type 1 diabetes that are being cared for at the special maternity ward at Södersjukhuset, n=45.
The expected to include is 100. Expected viable pregnancies: 50.
The maternal vaginal, fecal and oral microbiome will be sampled by "self-sampling" at home before, during and after the pregnancy, by this schedule:
1. Inclusion, before pregnancy after an appointment with the diabetic doctor or nurse. Or at the first visit at the special maternity care ward during pregnancy (around gestational week 8).
2. When the pregnancy is first discovered if the inclusion were before pregnancy.
3. Week 28.
4. When attending delivery ward in labor
5. 6-10 weeks postpartum from both the mother and the new-born. The tests will be sent to the obstetric research center at Södersjukhuset, where the tests will be saved in freezes. The analysis will be performed at CTMR at the Karolinska Institute.
Background, pregnancy and delivery data will then be associated with the woman microbiome in the vagina, in feces and in saliva.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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microbiome sampling
pregnant women with type 1 diabetes
sampling of microbiome
women will sample from vagina, feces, and saliva during pregnancy
Interventions
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sampling of microbiome
women will sample from vagina, feces, and saliva during pregnancy
Eligibility Criteria
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Inclusion Criteria
* Included as a patient at women's clinic Soderhospital in Stockholm
* Acceptant to sample her microbiome during pregnancy
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Eva Wiberg-Itzel
Associate professor
Principal Investigators
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Eva Wiberg-Itzel, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institute Sodersjukhuset Sweden
Locations
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Eva Wiberg-Itzel
Danderyd, Sverige, Sweden
Eva Wiberg-Itzel
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DM1
Identifier Type: -
Identifier Source: org_study_id
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