Study of the Microbiome and Pregnancy Outcomes in Women Aged 18 to 40 Planning to Conceive After Removing Contraceptive Devices

What this Trial Is About

Researchers are studying the microbiome and metabolome in women who have previously given birth and are planning to conceive again with the same partner. This observational study aims to understand how these biological factors relate to time to pregnancy, miscarriage, live birth, and pregnancy complications. The study will follow 500 women, recruited when they stop using contraception, over up to one year or until conception, and then through pregnancy if conception occurs. Participants will provide vaginal and rectal samples using a self-collection kit at the time they stop their contraceptive method, such as a copper or hormonal IUD or contraceptive implant, at midwife clinics in Stockholm. If a miscarriage occurs, an additional endometrial biopsy will be collected. Recruitment is planned over two years, with participants followed throughout conception and pregnancy. During the study, women will complete web-based questionnaires and provide biological samples. Researchers will assess microbiome profiles and metabolome related to pregnancy outcomes, including time to pregnancy, miscarriage, and live birth. They will also examine influences of age, BMI, medications, and other health factors on the microbiome. The study will monitor participants for up to one year or through pregnancy, with data collected to better understand fertility and pregnancy outcomes.

Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive