Preterm BirthPRIMENCT06281262
Selected Immunological Indicators and Microbiota in Patients With Premature Birth and Preeclampsia
An observational study of Preterm Birth and Preeclampsia, run by General University Hospital, Prague at 1 site in Czechia.
Trial summary
The goal is to demonstrate the relationship of the circulating pool of T-regulatory lymphocytes in the mother's peripheral blood with populations in the placentas and to compare with controls, what is the difference in the expression of individual regulatory molecules of T-regulatory lymphocytes according to new… Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Preterm Birth, Preeclampsia
- What is being tested?
- Peripheral blood collection and Swab sample collection
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 30 Jun 2023to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Adult
Study population: Pregnant women
Who may be able to join
- 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).
Who cannot join
- uterine malformations
- gestational age out of 9+0 - 12+0
- age out of 19-40
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Department of Gynaecology, Obstetrics and Neonatology of the First Faculty of Medicine of the Charles University and General University Hospital in Prague
Prague, 128 08
Zdeněk Laštůvka, MUDr., Ph.D., +420777724640, zdenek.lastuvka@vfn.cz
Michal Koucký, Doc., MUDr., Ph.D., +420603219916, michal.koucky@vfn.cz
About this study
Official title: The Role of Selected Immunological Indicators and Microbiota in Patients Experiencing Premature Birth and Preeclampsia
The goal is to demonstrate the relationship of the circulating pool of T-regulatory lymphocytes in the mother's peripheral blood with populations in the placentas and to compare with controls, what is the difference in the expression of individual regulatory molecules of T-regulatory lymphocytes according to new paradigms. The proportional and functional characteristics of T-regulatory lymphocytes will be correlated with the composition of the intestinal and vaginal microbiota.
Read the detailed description
OBJECTIVES
The primary objective of this project is to determine the differences between the circulating pool of regulatory Treg subpopulation proportions and the placental populations in patients with preterm birth and preeclampsia. Pilot study was conducted for the primary objective. Another objective is to evaluate the effect of microbiota on the regulation of Treg cells, especially in relation to mechanisms of preterm birth and preeclampsia. With growing knowledge of the role of microbiota, it is considered that the maternal microbiota could significantly influence setting of immunoregulatory responses even prenatally. Since Treg play a key role in regulating the immunological balance and are indispensable for induction and maintenance of peripheral tolerance, the investigators hypothesise that abnormalities in function of this population are important factors in increasing the risk of gestational pathologies (preterm birth and preeclampsia). Such dysregulation is most likely accompanied by disruption of the physiological Treg epigenetic profile which is in turn influenced by aberrant microbiota composition. Better understanding of these processes and identification of positively or negatively participating bacterial species could enable more reliable prediction of risk-pregnancy and allow for modulation of microbiota to be applied preventively.
Premature birth is defined as pregnancy termination before the end of the gestational week 37. It plays a role in 10% of all pregnancies including spontaneous or medically induced labours. The efforts to postpone premature labour are continuously developed to minimise the consequences such as low birth weight and other risk events. Preeclampsia is a serious blood pressure condition that develops during pregnancy. People with preeclampsia often have high blood pressure (hypertension) and high levels of protein in their urine (proteinuria). It plays role in 5% of all pregnancies. Preeclampsia typically develops after the 20th week of pregnancy. It can also affect other organs in the body and be dangerous for both the mother and her unborn child. Therefore, a great number of scientific studies are now focused on the early prediction of premature labour and preeclampsia and on finding a specific parameter to estimate female patients at premature labour and preeclampsia risk.
HYPOTHESIS AND AIMS
Hypothesis 1: Disbalance between tolerogenic T cell subsets (Treg, Th2, Th9 and Th22) and proinflammatory subsets (Th1 and Th17) is a sign of premature birth or preeclampsia.
Specific aim 1: Determine the differences between the circulating and the placental T cell subpopulations in patients with preterm birth and preeclampsia. Previously published analyses of Trees and their phenotypic properties give inconclusive or even contradictory results. For this reason, the investigators propose a more in depth approach combining deep immunophenotyping capable of identifying effector T cell, Treg and NK cell subsets and their qualitative phenotype together with assessment of functional capabilities of Tregs.
Hypothesis 2: Certain bacterial species of microbiota can be identified to modulate epigenetic maintenance of Treg phenotype.
Specific aim 2: Determine the influence of microbiota on the Treg regulation. Exposure to microbiota is one of the most important environmental factors introduced in the perinatal period. The capability of certain probiotic bacterial species to promote immunological tolerance, restrain inflammation and unwanted reactivity is being established in the context of intestinal health. Both bacteria and their metabolic products are known to shape the immune system. By influencing the epigenetic programming they modulate phenotype and function of a variety of immune cells including Tregs. The investigators hypothesise that beneficial bacterial species can be identified to promote appropriate epigenetic maintenance of Treg phenotype, function and stability, and thus support Treg tolerogenic role. On the contrary, certain bacterial species will contribute to Treg epigenetic dysregulation and introduce a more pro-inflammatory environment with functionally deficient Treg cells. To test this hypothesis, the investigators will characterise microbial composition of material collected from the mother by oral, rectal and vaginal swabs during pregnancy and at the time of birth.
CHARACTERISATION OF EXPECTED RESULTS
The main outcome of the project will be to improve the understanding of the regulatory processes taking part in the immune balance in preterm birth and preeclampsia. Special attention will be given to the dynamics and functional characteristics of Treg and their subpopulations, considering the role of maternal microbiota. The obtained results will be presented on both national and international congresses and symposia and also published in international impacted journals.
- Conditions
- Preterm Birth, Preeclampsia
- Being tested
- Peripheral blood collection, Swab sample collection
- Keywords
- Preterm labor, Regulatory T cells, Early pregnancy, Immunology, Maternal-fetal interface
- Medical subject headings
- Premature Birth, Pre-Eclampsia, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood collectionDiagnostic test
The phenotypic characteristics of leukocytes will be compared between the groups to identify immunological markers of women at risk of preterm delivery.
Samples from the controls will be taken to define a baseline for the measured leukocyte populations.
Swab sample collectionDiagnostic test
Oral, vaginal and rectal swabs will be collected and stored for analysis of microbiota at the time of inclusion. At birth, oral, vaginal and rectal swabs and part of the placenta (placental tissue) will be collected for further analysis.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Singletone pregnancy, gestational age 9+0 - 12+0, history of preeclampsia (PE) or spontaneous preterm birth (PTL = preterm labour) or pPROM (preterm premature rupture of membranes). Receives: Diagnostic Test: Peripheral blood collection; Diagnostic Test: Swab sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in selected T cell subpopulations in the first trimester associated with subsequent spontaneous preterm birth
The phenotypic characteristics of leukocytes will be compared between the two groups of pregnant women to identify immunological markers of preterm delivery. Peripheral blood from age-matched healthy nonpregnant women (N=20) will also be collected to define a baseline for the measured leukocyte populations. Furthermore, the composition of placenta infiltrating lymphocytes will be compared between groups and following delivery.
Measured: 3 years
Changes in selected T cell subpopulations in the first trimester associated with subsequent pre-eclampsia
The phenotypic characteristics of leukocytes will be compared between the two groups of pregnant women to identify immunological markers of pre-eclampsia. Peripheral blood from age-matched healthy nonpregnant women (N=20) will also be collected to define a baseline for the measured leukocyte populations. Furthermore, the composition of placenta infiltrating lymphocytes will be compared between groups and following delivery.
Measured: 3 years
Secondary outcomes (1)
Association of maternal microbiota and maternal T regulatory cell populations.
At birth, oral, vaginal and rectal swabs and part of the placenta (placental tissue) will be collected for analysis. Microbial composition of the swabs will be analysed using 16S rRNA sequencing analysis of microbiota and put in context with the T-cell regulatory population of the patient.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start30 Jun 2023
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic, Institute of Hematology and Blood Transfusion, Czech Republic
- Responsible party
- Principal investigator, Zdenek Lastuvka, General University Hospital, Prague
- Investigators
- Zdeněk Laštůvka, MD, PhD, Principal investigator, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281262
- Sponsor's protocol ID
- GIP-23-L-04-223
- Acronym
- PRIME
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perin J, Mulick A, Yeung D, Villavicencio F, Lopez G, Strong KL, Prieto-Merino D, Cousens S, Black RE, Liu L. Global, regional, and national causes of under-5 mortality in 2000-19: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet Child Adolesc Health. 2022 Feb;6(2):106-115. doi: 10.1016/S2352-4642(21)00311-4. Epub 2021 Nov 17.
PubMed 34800370Ohuma EO, Moller AB, Bradley E, Chakwera S, Hussain-Alkhateeb L, Lewin A, Okwaraji YB, Mahanani WR, Johansson EW, Lavin T, Fernandez DE, Dominguez GG, de Costa A, Cresswell JA, Krasevec J, Lawn JE, Blencowe H, Requejo J, Moran AC. National, regional, and global estimates of preterm birth in 2020, with trends from 2010: a systematic analysis. Lancet. 2023 Oct 7;402(10409):1261-1271. doi: 10.1016/S0140-6736(23)00878-4.
PubMed 37805217Manuck TA. Racial and ethnic differences in preterm birth: A complex, multifactorial problem. Semin Perinatol. 2017 Dec;41(8):511-518. doi: 10.1053/j.semperi.2017.08.010. Epub 2017 Sep 21.
PubMed 28941962Chawanpaiboon S, Vogel JP, Moller AB, Lumbiganon P, Petzold M, Hogan D, Landoulsi S, Jampathong N, Kongwattanakul K, Laopaiboon M, Lewis C, Rattanakanokchai S, Teng DN, Thinkhamrop J, Watananirun K, Zhang J, Zhou W, Gulmezoglu AM. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019 Jan;7(1):e37-e46. doi: 10.1016/S2214-109X(18)30451-0. Epub 2018 Oct 30.
PubMed 30389451Ream MA, Lehwald L. Neurologic Consequences of Preterm Birth. Curr Neurol Neurosci Rep. 2018 Jun 16;18(8):48. doi: 10.1007/s11910-018-0862-2.
PubMed 29907917Green ES, Arck PC. Pathogenesis of preterm birth: bidirectional inflammation in mother and fetus. Semin Immunopathol. 2020 Aug;42(4):413-429. doi: 10.1007/s00281-020-00807-y. Epub 2020 Sep 7.
PubMed 32894326Gomez-Lopez N, Arenas-Hernandez M, Romero R, Miller D, Garcia-Flores V, Leng Y, Xu Y, Galaz J, Hassan SS, Hsu CD, Tse H, Sanchez-Torres C, Done B, Tarca AL. Regulatory T Cells Play a Role in a Subset of Idiopathic Preterm Labor/Birth and Adverse Neonatal Outcomes. Cell Rep. 2020 Jul 7;32(1):107874. doi: 10.1016/j.celrep.2020.107874.
PubMed 32640239Robertson SA, Care AS, Moldenhauer LM. Regulatory T cells in embryo implantation and the immune response to pregnancy. J Clin Invest. 2018 Oct 1;128(10):4224-4235. doi: 10.1172/JCI122182. Epub 2018 Oct 1.
PubMed 30272581Xue L, Gyles SL, Wettey FR, Gazi L, Townsend E, Hunter MG, Pettipher R. Prostaglandin D2 causes preferential induction of proinflammatory Th2 cytokine production through an action on chemoattractant receptor-like molecule expressed on Th2 cells. J Immunol. 2005 Nov 15;175(10):6531-6. doi: 10.4049/jimmunol.175.10.6531.
PubMed 16272307Tsuda S, Zhang X, Hamana H, Shima T, Ushijima A, Tsuda K, Muraguchi A, Kishi H, Saito S. Clonally Expanded Decidual Effector Regulatory T Cells Increase in Late Gestation of Normal Pregnancy, but Not in Preeclampsia, in Humans. Front Immunol. 2018 Aug 24;9:1934. doi: 10.3389/fimmu.2018.01934. eCollection 2018.
PubMed 30197648Rowe JH, Ertelt JM, Xin L, Way SS. Pregnancy imprints regulatory memory that sustains anergy to fetal antigen. Nature. 2012 Oct 4;490(7418):102-6. doi: 10.1038/nature11462. Epub 2012 Sep 26.
PubMed 23023128Schober L, Radnai D, Schmitt E, Mahnke K, Sohn C, Steinborn A. Term and preterm labor: decreased suppressive activity and changes in composition of the regulatory T-cell pool. Immunol Cell Biol. 2012 Nov;90(10):935-44. doi: 10.1038/icb.2012.33. Epub 2012 Jul 3.
PubMed 22751216Tilburgs T, Roelen DL, van der Mast BJ, de Groot-Swings GM, Kleijburg C, Scherjon SA, Claas FH. Evidence for a selective migration of fetus-specific CD4+CD25bright regulatory T cells from the peripheral blood to the decidua in human pregnancy. J Immunol. 2008 Apr 15;180(8):5737-45. doi: 10.4049/jimmunol.180.8.5737.
PubMed 18390759Krop J, Heidt S, Claas FHJ, Eikmans M. Regulatory T Cells in Pregnancy: It Is Not All About FoxP3. Front Immunol. 2020 Jun 23;11:1182. doi: 10.3389/fimmu.2020.01182. eCollection 2020.
PubMed 32655556Green S, Politis M, Rallis KS, Saenz de Villaverde Cortabarria A, Efthymiou A, Mureanu N, Dalrymple KV, Scotta C, Lombardi G, Tribe RM, Nicolaides KH, Shangaris P. Regulatory T Cells in Pregnancy Adverse Outcomes: A Systematic Review and Meta-Analysis. Front Immunol. 2021 Oct 29;12:737862. doi: 10.3389/fimmu.2021.737862. eCollection 2021.
PubMed 34777347
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Selected Immunological Indicators and Microbiota in Patients Experiencing Premature Birth and Preeclampsia
- ClinicalTrials.gov ID
- NCT06281262
- Acronym / sponsor ID
- PRIME / GIP-23-L-04-223
- Conditions
- Preterm Birth, Preeclampsia
- Keywords
- Preterm labor, Regulatory T cells, Early pregnancy, Immunology, Maternal-fetal interface
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic, Institute of Hematology and Blood Transfusion, Czech Republic
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to demonstrate the relationship of the circulating pool of T-regulatory lymphocytes in the mother's peripheral blood with populations in the placentas and to compare with controls, what is the difference in the expression of individual regulatory molecules of T-regulatory lymphocytes according to new paradigms. The proportional and functional characteristics of T-regulatory lymphocytes will be correlated with the composition of the intestinal and vaginal microbiota.
Detailed description
OBJECTIVES
The primary objective of this project is to determine the differences between the circulating pool of regulatory Treg subpopulation proportions and the placental populations in patients with preterm birth and preeclampsia. Pilot study was conducted for the primary objective. Another objective is to evaluate the effect of microbiota on the regulation of Treg cells, especially in relation to mechanisms of preterm birth and preeclampsia. With growing knowledge of the role of microbiota, it is considered that the maternal microbiota could significantly influence setting of immunoregulatory responses even prenatally. Since Treg play a key role in regulating the immunological balance and are indispensable for induction and maintenance of peripheral tolerance, the investigators hypothesise that abnormalities in function of this population are important factors in increasing the risk of gestational pathologies (preterm birth and preeclampsia). Such dysregulation is most likely accompanied by disruption of the physiological Treg epigenetic profile which is in turn influenced by aberrant microbiota composition. Better understanding of these processes and identification of positively or negatively participating bacterial species could enable more reliable prediction of risk-pregnancy and allow for modulation of microbiota to be applied preventively.
Premature birth is defined as pregnancy termination before the end of the gestational week 37. It plays a role in 10% of all pregnancies including spontaneous or medically induced labours. The efforts to postpone premature labour are continuously developed to minimise the consequences such as low birth weight and other risk events. Preeclampsia is a serious blood pressure condition that develops during pregnancy. People with preeclampsia often have high blood pressure (hypertension) and high levels of protein in their urine (proteinuria). It plays role in 5% of all pregnancies. Preeclampsia typically develops after the 20th week of pregnancy. It can also affect other organs in the body and be dangerous for both the mother and her unborn child. Therefore, a great number of scientific studies are now focused on the early prediction of premature labour and preeclampsia and on finding a specific parameter to estimate female patients at premature labour and preeclampsia risk.
HYPOTHESIS AND AIMS
Hypothesis 1: Disbalance between tolerogenic T cell subsets (Treg, Th2, Th9 and Th22) and proinflammatory subsets (Th1 and Th17) is a sign of premature birth or preeclampsia.
Specific aim 1: Determine the differences between the circulating and the placental T cell subpopulations in patients with preterm birth and preeclampsia. Previously published analyses of Trees and their phenotypic properties give inconclusive or even contradictory results. For this reason, the investigators propose a more in depth approach combining deep immunophenotyping capable of identifying effector T cell, Treg and NK cell subsets and their qualitative phenotype together with assessment of functional capabilities of Tregs.
Hypothesis 2: Certain bacterial species of microbiota can be identified to modulate epigenetic maintenance of Treg phenotype.
Specific aim 2: Determine the influence of microbiota on the Treg regulation. Exposure to microbiota is one of the most important environmental factors introduced in the perinatal period. The capability of certain probiotic bacterial species to promote immunological tolerance, restrain inflammation and unwanted reactivity is being established in the context of intestinal health. Both bacteria and their metabolic products are known to shape the immune system. By influencing the epigenetic programming they modulate phenotype and function of a variety of immune cells including Tregs. The investigators hypothesise that beneficial bacterial species can be identified to promote appropriate epigenetic maintenance of Treg phenotype, function and stability, and thus support Treg tolerogenic role. On the contrary, certain bacterial species will contribute to Treg epigenetic dysregulation and introduce a more pro-inflammatory environment with functionally deficient Treg cells. To test this hypothesis, the investigators will characterise microbial composition of material collected from the mother by oral, rectal and vaginal swabs during pregnancy and at the time of birth.
CHARACTERISATION OF EXPECTED RESULTS
The main outcome of the project will be to improve the understanding of the regulatory processes taking part in the immune balance in preterm birth and preeclampsia. Special attention will be given to the dynamics and functional characteristics of Treg and their subpopulations, considering the role of maternal microbiota. The obtained results will be presented on both national and international congresses and symposia and also published in international impacted journals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Diagnostic Test: Peripheral blood collection, Diagnostic Test: Swab sample collectionSingletone pregnancy, gestational age 9+0 - 12+0, history of preeclampsia (PE) or spontaneous preterm birth (PTL = preterm labour) or pPROM (preterm premature rupture of membranes). |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- uterine malformations
- gestational age out of 9+0 - 12+0
- age out of 19-40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood collectionThe phenotypic characteristics of leukocytes will be compared between the groups to identify immunological markers of women at risk of preterm delivery. Samples from the controls will be taken to define a baseline for the measured leukocyte populations. | Diagnostic test | Pregnant women |
| Swab sample collectionOral, vaginal and rectal swabs will be collected and stored for analysis of microbiota at the time of inclusion. At birth, oral, vaginal and rectal swabs and part of the placenta (placental tissue) will be collected for further analysis. | Diagnostic test | Pregnant women |
Primary outcome
Changes in selected T cell subpopulations in the first trimester associated with subsequent spontaneous preterm birth
Time frame: 3 years
The phenotypic characteristics of leukocytes will be compared between the two groups of pregnant women to identify immunological markers of preterm delivery. Peripheral blood from age-matched healthy nonpregnant women (N=20) will also be collected to define a baseline for the measured leukocyte populations. Furthermore, the composition of placenta infiltrating lymphocytes will be compared between groups and following delivery.
Changes in selected T cell subpopulations in the first trimester associated with subsequent pre-eclampsia
Time frame: 3 years
The phenotypic characteristics of leukocytes will be compared between the two groups of pregnant women to identify immunological markers of pre-eclampsia. Peripheral blood from age-matched healthy nonpregnant women (N=20) will also be collected to define a baseline for the measured leukocyte populations. Furthermore, the composition of placenta infiltrating lymphocytes will be compared between groups and following delivery.
1 secondary outcome
Association of maternal microbiota and maternal T regulatory cell populations.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 34800370Perin J, Mulick A, Yeung D, Villavicencio F, Lopez G, Strong KL, Prieto-Merino D, Cousens S, Black RE, Liu L. Global, regional, and national causes of under-5 mortality in 2000-19: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet Child Adolesc Health. 2022 Feb;6(2):106-115. doi: 10.1016/S2352-4642(21)00311-4. Epub 2021 Nov 17.
- Background: PubMed 37805217Ohuma EO, Moller AB, Bradley E, Chakwera S, Hussain-Alkhateeb L, Lewin A, Okwaraji YB, Mahanani WR, Johansson EW, Lavin T, Fernandez DE, Dominguez GG, de Costa A, Cresswell JA, Krasevec J, Lawn JE, Blencowe H, Requejo J, Moran AC. National, regional, and global estimates of preterm birth in 2020, with trends from 2010: a systematic analysis. Lancet. 2023 Oct 7;402(10409):1261-1271. doi: 10.1016/S0140-6736(23)00878-4.
- Background: PubMed 28941962Manuck TA. Racial and ethnic differences in preterm birth: A complex, multifactorial problem. Semin Perinatol. 2017 Dec;41(8):511-518. doi: 10.1053/j.semperi.2017.08.010. Epub 2017 Sep 21.
- Background: PubMed 30389451Chawanpaiboon S, Vogel JP, Moller AB, Lumbiganon P, Petzold M, Hogan D, Landoulsi S, Jampathong N, Kongwattanakul K, Laopaiboon M, Lewis C, Rattanakanokchai S, Teng DN, Thinkhamrop J, Watananirun K, Zhang J, Zhou W, Gulmezoglu AM. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019 Jan;7(1):e37-e46. doi: 10.1016/S2214-109X(18)30451-0. Epub 2018 Oct 30.
- Background: PubMed 29907917Ream MA, Lehwald L. Neurologic Consequences of Preterm Birth. Curr Neurol Neurosci Rep. 2018 Jun 16;18(8):48. doi: 10.1007/s11910-018-0862-2.
- Background: PubMed 32894326Green ES, Arck PC. Pathogenesis of preterm birth: bidirectional inflammation in mother and fetus. Semin Immunopathol. 2020 Aug;42(4):413-429. doi: 10.1007/s00281-020-00807-y. Epub 2020 Sep 7.
- Background: PubMed 32640239Gomez-Lopez N, Arenas-Hernandez M, Romero R, Miller D, Garcia-Flores V, Leng Y, Xu Y, Galaz J, Hassan SS, Hsu CD, Tse H, Sanchez-Torres C, Done B, Tarca AL. Regulatory T Cells Play a Role in a Subset of Idiopathic Preterm Labor/Birth and Adverse Neonatal Outcomes. Cell Rep. 2020 Jul 7;32(1):107874. doi: 10.1016/j.celrep.2020.107874.
- Background: PubMed 30272581Robertson SA, Care AS, Moldenhauer LM. Regulatory T cells in embryo implantation and the immune response to pregnancy. J Clin Invest. 2018 Oct 1;128(10):4224-4235. doi: 10.1172/JCI122182. Epub 2018 Oct 1.
- Background: PubMed 16272307Xue L, Gyles SL, Wettey FR, Gazi L, Townsend E, Hunter MG, Pettipher R. Prostaglandin D2 causes preferential induction of proinflammatory Th2 cytokine production through an action on chemoattractant receptor-like molecule expressed on Th2 cells. J Immunol. 2005 Nov 15;175(10):6531-6. doi: 10.4049/jimmunol.175.10.6531.
- Background: PubMed 30197648Tsuda S, Zhang X, Hamana H, Shima T, Ushijima A, Tsuda K, Muraguchi A, Kishi H, Saito S. Clonally Expanded Decidual Effector Regulatory T Cells Increase in Late Gestation of Normal Pregnancy, but Not in Preeclampsia, in Humans. Front Immunol. 2018 Aug 24;9:1934. doi: 10.3389/fimmu.2018.01934. eCollection 2018.
- Background: PubMed 23023128Rowe JH, Ertelt JM, Xin L, Way SS. Pregnancy imprints regulatory memory that sustains anergy to fetal antigen. Nature. 2012 Oct 4;490(7418):102-6. doi: 10.1038/nature11462. Epub 2012 Sep 26.
- Background: PubMed 22751216Schober L, Radnai D, Schmitt E, Mahnke K, Sohn C, Steinborn A. Term and preterm labor: decreased suppressive activity and changes in composition of the regulatory T-cell pool. Immunol Cell Biol. 2012 Nov;90(10):935-44. doi: 10.1038/icb.2012.33. Epub 2012 Jul 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zdeněk Laštůvka, MD, PhD principal investigator
General University Hospital, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Preeclampsia, run by General University Hospital, Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zdeněk Laštůvka, MD, PhD (+420224967432, zdenek.lastuvka@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in selected T cell subpopulations in the first trimester associated with subsequent spontaneous preterm birth (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06281262, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.