NCT05604768

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2025

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

3 years

First QC Date

October 14, 2022

Last Update Submit

October 30, 2022

Conditions

Pregnancy

Keywords

ParturitionImmunityMyelogenous suppressor cellsFetal free DNA

Outcome Measures

Primary Outcomes (7)

  • 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.

    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 normal pregnancy and delivery

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

    The frequency of pDC in maternal blood and placenta during normal pregnancy and 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 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.

    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 Nature Killer (NK) cells in normal pregnancy and delivery

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

    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 normal pregnancy and delivery

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

    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 (7)

  • 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 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 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

  • +2 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

Study Officials

  • Wei Yi, Doctor

    Beijing Ditan Hospital

    STUDY DIRECTOR

Central Study Contacts

Wei Yi, Doctor

CONTACT

13683687062yiwei1215@163.com

Yao Xie, Doctor

CONTACT

13501093293xieyao00120184@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Obstetrics and Gynecology

Study Record Dates

First Submitted

October 14, 2022

First Posted

November 3, 2022

Study Start

March 28, 2022

Primary Completion

March 28, 2025

Study Completion

March 28, 2025

Last Updated

November 3, 2022

Record last verified: 2022-10

Locations

CN(1)