Investigating immune indicators and microbiota in mothers with preterm birth and preeclampsia
The Role of Selected Immunological Indicators and Microbiota in Patients Experiencing Premature Birth and Preeclampsia
This study is trying to see how certain immune cells and bacteria in mothers' bodies are linked to preterm birth and preeclampsia to find out if they can help predict or prevent these issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 19 Years to 40 Years |
| Sex | Female |
| Sponsor | General University Hospital, Prague Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT06281262 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between the circulating pool of regulatory T cells in the mother's blood and their populations in the placenta, comparing these with control groups. It will also evaluate how the composition of maternal intestinal and vaginal microbiota influences the regulation of Treg cells, particularly in the context of preterm birth and preeclampsia. By understanding these immunological and microbiological interactions, the study seeks to identify factors that may predict and potentially prevent these gestational complications.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 19-40 with a singleton pregnancy between 9 and 12 weeks gestation who have a history of preeclampsia or spontaneous preterm birth.
Not a fit: Patients with uterine malformations or those outside the specified age and gestational age criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction and prevention strategies for preterm birth and preeclampsia.
How similar studies have performed: While the specific approach of correlating Treg cell populations with microbiota in this context is novel, related studies have shown promise in understanding the role of immune regulation in pregnancy complications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * singletone pregnancy * gestational age 9+0 - 12+0 * history of preeclampsia (PE) * history of spontaneous preterm birth (PTL = preterm labour) * history of pPROM (preterm premature rupture of membranes). Exclusion Criteria: * uterine malformations * gestational age out of 9+0 - 12+0 * age out of 19-40
Where this trial is running
Prague
- Department of Gynaecology, Obstetrics and Neonatology of the First Faculty of Medicine of the Charles University and General University Hospital in Prague — Prague, Czechia (Recruiting)
Study contacts
- Principal investigator: Zdeněk Laštůvka, MD, PhD — General University Hospital, Prague
- Study coordinator: Zdeněk Laštůvka, MD, PhD
- Email: zdenek.lastuvka@vfn.cz
- Phone: +420224967432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.