Skip to main content
Clinical Trials/NCT05604768
NCT05604768
Recruiting
Not Applicable

Study on the Initiation and Immunological Mechanism of Parturition

Beijing Ditan Hospital1 site in 1 country40 target enrollmentMarch 28, 2022
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Beijing Ditan Hospital
Enrollment
40
Locations
1
Primary Endpoint
The change of functional molecules expression of myeloid-derived suppressor cells (MDSCs) in normal pregnancy and delivery
Status
Recruiting
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 28, 2022
End Date
March 28, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Beijing Ditan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Wei Yi

Director, Head of Obstetrics and Gynecology

Beijing Ditan Hospital

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

The change of functional molecules expression of myeloid-derived suppressor cells (MDSCs) in normal pregnancy and delivery

Time Frame: at 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after delivery

The expression of functional molecules of MDSCs in maternal blood and placenta during normal pregnancy and delivery.

The change of the content of cffDNA in normal pregnancy and delivery

Time Frame: at 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after delivery

The content of cffDNA in maternal blood and placenta during normal pregnancy and delivery.

The change of the frequency of Nature Killer (NK) cells in normal pregnancy and delivery

Time Frame: at 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after delivery

The frequency of NK cells in maternal blood and placenta during normal pregnancy and delivery.

The change of the frequency of plasmacytoid dendritic cells (pDC) in normal pregnancy and delivery

Time Frame: at 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after delivery

The frequency of pDC 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 delivery

Time Frame: at 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after delivery

The frequency of MDSCs 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 delivery

Time Frame: at 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after delivery

The expression of functional molecules of pDC 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 delivery

Time Frame: at 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after delivery

The expression of functional molecules of NK cells in maternal blood and placenta during normal pregnancy and delivery.

Secondary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials