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Study on Initiation and Immunological Mechanism of Childbirth

Study on the Initiation and Immunological Mechanism of Parturition

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05604768
Enrollment
40
Registered
2022-11-03
Start date
2022-03-28
Completion date
2025-03-28
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Parturition, Immunity, Myelogenous suppressor cells, Fetal free DNA

Brief summary

This study is a prospective observational study. The participants including 40 pregnant women who have been filed and delivered in our hospital will enrolled, collect venous blood will be collected at different stages of pregnancy, delivery, postpartum to detect the concentration of fetal free DNA, the frequency of associated immune cells, and the expression of functional molecules, so as to explore the immunological mechanism of delivery initiation.

Detailed description

This study is a prospective observational study. The participants including 40 pregnant women (20 normal parturients and 20 pregnant women with threatened preterm delivery) who have been filed and delivered in our hospital will enrolled, collect venous blood will be collected before 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, during parturition, and at 42 days after delivery to conduct the following research: 1) Studying the frequency of peripheral blood MDSCs, pDC and NK cells and the expression of functional molecules at different stages of pregnancy (12,24,36 weeks of pregnancy), before delivery and 42 days after delivery through the expression of relevant functional molecules. 2) Detecting the levels of cytokines and chemokines in peripheral blood at different stages of pregnancy (12,24,36 weeks of pregnancy), before delivery and 42 days after delivery, including: IL-1 β, IL-6, IL-10, IL-18, TGF- β and TNF- α, GM-CSF , IL-23, IL-17, IL-13, IL-4, IL-2, IFN-, IFN-, IL-8, GRO α, GCSF, GMCSM, CCL2, CCL5, CCL26,CXCL8, CXCL12，PGE2, M-CSF, COX2, CCL3, CCL4, CXCL1, IDO, Arg-1, ROS and NO. 3) Detection of cffDNA concentration in peripheral blood at different stages of pregnancy (12,24,36 weeks of pregnancy), before delivery and 42 days after delivery. 4) Detection of frequency of MDSCs, pDC and NK cells and expression of functional molecules in placenta. 5) Frequency of peripheral blood MDSCs, pDC and NK cells, expression of functional molecules, cytokine level and cffDNA concentration in pregnant women with threatened preterm labor. 6) Collecting and studying the demographic data of pregnant women at different stages of pregnancy (12,24,36 weeks of pregnancy), before delivery and 42 days after delivery, adverse events of mothers and infants in the perinatal period, and auxiliary examination data (blood routine test, liver and kidney function, TSH, infection index of Aimei B and C, TSH, blood glucose, blood coagulation function, estrogen and progesterone levels, ultrasound, electrocardiogram, etc).

Interventions

None listed

Sponsors

Beijing Ditan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 20 normal parturients and 20 pregnant women with threatened preterm labor who had undergone antenatal examination and delivery in Beijing Ditan Hospital were fully informed of the risks and volunteered to join the study and signed the informed consent form.

Exclusion criteria

* 1\. Combined with HCV, HIV, syphilis or other infectious diseases. * 2\. Chronic diseases such as diabetes, hypertension, thyroid disease and autoimmune disease. * 3\. Both husband and wife or their families have delivered congenital abnormal fetus in the past. * 4\. Either spouse is unwilling to participate in this study.

Design outcomes

Primary

MeasureTime frameDescription
The change of the content of cffDNA in normal pregnancy and deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe content of cffDNA in maternal blood and placenta during normal pregnancy and delivery.
The change of the frequency of myeloid-derived suppressor cells (MDSCs) in normal pregnancy and deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe frequency of MDSCs in maternal blood and placenta during normal pregnancy and delivery.
The change of functional molecules expression of myeloid-derived suppressor cells (MDSCs) in normal pregnancy and deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe expression of functional molecules of MDSCs in maternal blood and placenta during normal pregnancy and delivery.
The change of the frequency of plasmacytoid dendritic cells (pDC) in normal pregnancy and deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe frequency of pDC in maternal blood and placenta during normal pregnancy and delivery.
The change of the functional molecules expression of plasmacytoid dendritic cells (pDC) in normal pregnancy and deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe expression of functional molecules of pDC in maternal blood and placenta during normal pregnancy and delivery.
The change of the frequency of Nature Killer (NK) cells in normal pregnancy and deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe frequency of NK cells in maternal blood and placenta during normal pregnancy and delivery.
The change of the functional molecules expression of Nature Killer (NK) cells in normal pregnancy and deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe expression of functional molecules of NK cells in maternal blood and placenta during normal pregnancy and delivery.

Secondary

MeasureTime frameDescription
The change of the frequency of myeloid-derived suppressor cells (MDSCs) in Pregnant women with threatened premature deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe frequency of MDSCs in maternal blood and placenta in Pregnant women with threatened premature delivery.
The change of functional molecules expression of myeloid-derived suppressor cells (MDSCs) in Pregnant women with threatened premature deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe expression of functional molecules of MDSCs in maternal blood and placenta in Pregnant women with threatened premature delivery.
The change of the frequency of plasmacytoid dendritic cells (pDC) in Pregnant women with threatened premature deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe frequency of pDC in maternal blood and placenta in Pregnant women with threatened premature delivery.
The change of functional molecules expression of plasmacytoid dendritic cells (pDC) in Pregnant women with threatened premature deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe expression of functional molecules of pDC in maternal blood and placenta in Pregnant women with threatened premature delivery.
The change of frequency of Nature Killer (NK) cells in Pregnant women with threatened premature deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe frequency of NK cells in maternal blood and placenta in Pregnant women with threatened premature delivery.
The change of functional molecules expression of Nature Killer (NK) cells in Pregnant women with threatened premature deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe expression of functional molecules of NK cells in maternal blood and placenta in Pregnant women with threatened premature delivery.
The change of the content of cffDNA in Pregnant women with threatened premature deliveryat 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after deliveryThe content of cffDNA in maternal blood and placenta in Pregnant women with threatened premature delivery.

Countries

China

Contacts

Primary ContactWei Yi, Doctor
yiwei1215@163.com13683687062
Backup ContactYao Xie, Doctor
xieyao00120184@sina.com13501093293

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026