SweMaMi DMI, Microbiome

• Conditions: Type 1 Diabetes
• Interventions: Other: sampling of microbiome

• Registration Number: NCT04346524
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Prospective cohort. All women with type 1 diabetes that are planning a pregnancy and being cared for at the diabetic ward at Södersjukhuset will be asked to participate, n= 55.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-11
• Study First Posted: 2020-04-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-21
• Last Update Posted: 2021-11-23
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Read More

Exclusion Criteria

• Women without type 1 diabetes

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
microbiome sampling	sampling of microbiome	pregnant women with type 1 diabetes

Primary Outcome Measures

Name	Time	Method
Maternal complications during pregnancy	through study completion, an average of 1 year	The frequency of Preeklampsia, hypertension and other pregnancy complications

Secondary Outcome Measures

Name	Time	Method
Fetal complications during pregnancy	through study completion, an average of 1 year	Large for gestational age

Trial Locations

Locations (1)

Eva Wiberg-Itzel; 🇸🇪 Stockholm, Sweden