Skip to content

SweMaMi DMI, Microbiome

SweMaMi DM1, Diabetic Women's Microbiome During Pregnancy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04346524
Enrollment
100
Registered
2020-04-15
Start date
2020-04-01
Completion date
2022-12-30
Last updated
2021-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes, Microbioma, maternal and fetal pregnacy outcomes

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.

Interventions

OTHERsampling of microbiome

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

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

* Women without type 1 diabetes

Design outcomes

Primary

MeasureTime frameDescription
Maternal complications during pregnancythrough study completion, an average of 1 yearThe frequency of Preeklampsia, hypertension and other pregnancy complications

Secondary

MeasureTime frameDescription
Fetal complications during pregnancythrough study completion, an average of 1 yearLarge for gestational age

Countries

Sweden

Contacts

Primary ContactEva Wiberg-Itzel, PhD
eva.itzel@telia.com+46708775346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026