NCT04346524

SweMaMi DMI, Microbiome

SweMaMi DM1, Diabetic Women's Microbiome During Pregnancy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
OTHER	sampling of microbiome	women will sample from vagina, feces, and saliva during pregnancy

Timeline

• Start date: 2020-04-01
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2020-04-15
• Last updated: 2021-11-23

Locations

2 sites across 1 country: Sweden