CClinicalTrials.gg
Status unknownNCT05604768Updated Nov 3, 2022

Study on Initiation and Immunological Mechanism of Childbirth

An observational study in Pregnancy, sponsored by Beijing Ditan Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-03.

Sponsored by Beijing Ditan Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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).

02

Conditions studied

  • Pregnancy

Keywords

  • Parturition
  • Immunity
  • Myelogenous suppressor cells
  • Fetal free DNA
03

In context

Lead sponsor

Beijing Ditan Hospital is the lead sponsor of 52 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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.

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

Exclusion Criteria:

    1. Combined with HCV, HIV, syphilis or other infectious diseases.
    1. Chronic diseases such as diabetes, hypertension, thyroid disease and autoimmune disease.
    1. Both husband and wife or their families have delivered congenital abnormal fetus in the past.
    1. Either spouse is unwilling to participate in this study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Normal parturient group

    20 normal parturients 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.

  • Pregnant women with threatened premature delivery group

    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.

06

What researchers measure

Primary outcomes

  1. The change of the frequency of myeloid-derived suppressor cells (MDSCs) in normal pregnancy and delivery

    The frequency of MDSCs in maternal blood and placenta during 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

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

    The expression of functional molecules of MDSCs in maternal blood and placenta during 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

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

    The frequency of pDC in maternal blood and placenta during 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

  4. The change of the functional molecules expression of plasmacytoid dendritic cells (pDC) in normal pregnancy and delivery

    The expression of functional molecules of pDC in maternal blood and placenta during 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

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

    The frequency of NK cells in maternal blood and placenta during 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

  6. The change of the functional molecules expression of Nature Killer (NK) cells in normal pregnancy and delivery

    The expression of functional molecules of NK cells in maternal blood and placenta during 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

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

    The content of cffDNA in maternal blood and placenta during 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

Secondary outcomes

  1. The change of the frequency of myeloid-derived suppressor cells (MDSCs) in Pregnant women with threatened premature delivery

    The frequency of MDSCs in maternal blood and placenta in Pregnant women with threatened premature 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

  2. The change of functional molecules expression of myeloid-derived suppressor cells (MDSCs) in Pregnant women with threatened premature delivery

    The expression of functional molecules of MDSCs in maternal blood and placenta in Pregnant women with threatened premature 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

  3. The change of the frequency of plasmacytoid dendritic cells (pDC) in Pregnant women with threatened premature delivery

    The frequency of pDC in maternal blood and placenta in Pregnant women with threatened premature 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

  4. The change of functional molecules expression of plasmacytoid dendritic cells (pDC) in Pregnant women with threatened premature delivery

    The expression of functional molecules of pDC in maternal blood and placenta in Pregnant women with threatened premature 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

  5. The change of frequency of Nature Killer (NK) cells in Pregnant women with threatened premature delivery

    The frequency of NK cells in maternal blood and placenta in Pregnant women with threatened premature 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

  6. The change of functional molecules expression of Nature Killer (NK) cells in Pregnant women with threatened premature delivery

    The expression of functional molecules of NK cells in maternal blood and placenta in Pregnant women with threatened premature 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

  7. The change of the content of cffDNA in Pregnant women with threatened premature delivery

    The content of cffDNA in maternal blood and placenta in Pregnant women with threatened premature 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

07

Study locations

1 of 1 sites recruiting
  • Beijing Ditan Hospital, Capital Medical University
    Beijing, Beijing 100015, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05604768
Lead sponsor
Beijing Ditan Hospital
Responsible party
Wei Yi (Director, Head of Obstetrics and Gynecology, Beijing Ditan Hospital) — Principal investigator
First posted
Nov 3, 2022
Start date
Mar 28, 2022
Primary completion
Mar 28, 2025 (estimated)
Completion
Mar 28, 2025 (estimated)
Last update
Nov 3, 2022

Study contacts

Wei Yi, Doctor
Contact
yiwei1215@163.com
13683687062
Yao Xie, Doctor
Contact
xieyao00120184@sina.com
13501093293
Wei Yi, Doctor
study director · Beijing Ditan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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