Investigating the microbiome's effect on pregnancy outcomes in women planning to conceive

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the role of the microbiome in women who have previously given birth and are planning to conceive again. Participants will be recruited at midwife clinics in Stockholm, Sweden, at the time of contraceptive device removal. A total of 500 women aged 18-40 will be followed for up to one year or until conception, with additional monitoring throughout pregnancy if conception occurs. The study will analyze vaginal and rectal microbiome and metabolome samples to assess their impact on fertility and pregnancy outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Reproduktionscentrum Akademiska sjukhuset
  Uppsala, Sweden Recruiting
• Reproductive Medicine, Karolinska University Hospital
  Stockholm, Huddinge, Sweden Not yet recruiting

Study contacts

• Study coordinator: Lars Holmgren, Professor
• Email: lars.holmgren@ki.se
• Phone: 046734036794

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.