Contraception, Fertility, Metabolome, Microbial Colonization, Pregnancy Complications, Pregnancy Loss
Conditions
Keywords
cohort, fertility, microbiome, microbiota
Brief summary
This study aims to investigate the microbiome of women with previously proven fertility who plan to become pregnant.
Detailed description
The women will be recruited at the time of removal of a copper or hormonal intrauterine device (IUD) or removal of a contraceptive implant at the barnmorskemottagningar (midwife clinics) in Stockholm's county in Sweden. A total of 500 women will be included in the study and will be followed until conception or up to the end of 1 year, whichever comes first. If conception occurs, the woman will be followed throughout pregnancy. Participant recruitment will take place over a period of two years.
Interventions
DIAGNOSTIC_TESTVaginal and rectal microbiome and metabolome
Vaginal- and rectal sampling as a self-kit will be taken by the pat when ceasing the contraception at the midwife clinic when confirmed a clinical pregnancy and if a miscarriage occurs. If a miscarriage occurs additionally to the self-kit an endometrial biopsy will be taken.
Sponsors
Karolinska University Hospital
Karolinska Institutet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Women with a previous live birth in the past 5 years and planning a new pregnancy with the same male partner. * 18-40 years of age * Swedish personal identity number and a Swedish address (to send a sampling self-kit) * Sufficient understanding of spoken and written Swedish or English to provide informed consent and complete the web-based questionnaire.
Exclusion criteria
* Women who do not have a child yet and plan to cease their contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed. | 2024 |
Secondary
| Measure | Time frame |
|---|---|
| The microbiome profile for women above age >38 and women below <38. | 2024 |
| The influence of BMI, medications and comorbidities on the microbiome profiles. | 2024 |
| Microbiome profiles and metabolome related to obstetric outcomes | 2024 |
| The metabolome of the recognized microbiome for women with normal pregnancy outcomes | 2024 |
| The metabolome of the recognized microbiome for women who develop miscarriage or other pregnancy complications | 2024 |
| Microbiome profile for those women who don't conceive within a year. | 2024 |
Countries
Sweden
Contacts
Primary ContactLars Holmgren, Professor
Backup ContactSebastian Sebastian Brusell Gidlöf, PhD
Outcome results
None listed