An observational study in Type 1 Diabetes, sponsored by Karolinska Institutet. Status unknown at 2 sites in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by Karolinska Institutet · Observational
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.
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:
Background, pregnancy and delivery data will then be associated with the woman microbiome in the vagina, in feces and in saliva.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
pregnant women with type 1 diabetes
Exclusion Criteria:
pregnant women with type 1 diabetes
Other: sampling of microbiome
women will sample from vagina, feces, and saliva during pregnancy
Maternal complications during pregnancy
The frequency of Preeklampsia, hypertension and other pregnancy complications
Time frame: through study completion, an average of 1 year
Fetal complications during pregnancy
Large for gestational age
Time frame: through study completion, an average of 1 year
Plan to share: Undecided — We have not discussed this question yet
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Karolinska Institutet