PregnancyNCT05604768
Study on Initiation and Immunological Mechanism of Childbirth
An observational study of Pregnancy, run by Beijing Ditan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2022to 28 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
Wei Yi, 13683687062, yiwei1215@163.com
Yao Xie, 13501093293, xieyao00120184@sina.com
About this study
Official title: Study on the Initiation and Immunological Mechanism of Parturition
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).
- Conditions
- Pregnancy
- Keywords
- Parturition, Immunity, Myelogenous suppressor cells, Fetal free DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The frequency of MDSCs in maternal blood and placenta in Pregnant women with threatened premature delivery.
Measured: 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
The expression of functional molecules of MDSCs in maternal blood and placenta in Pregnant women with threatened premature delivery.
Measured: 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
The frequency of pDC in maternal blood and placenta in Pregnant women with threatened premature delivery.
Measured: 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
The expression of functional molecules of pDC in maternal blood and placenta in Pregnant women with threatened premature delivery.
Measured: 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
The frequency of NK cells in maternal blood and placenta in Pregnant women with threatened premature delivery.
Measured: 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
The expression of functional molecules of NK cells in maternal blood and placenta in Pregnant women with threatened premature delivery.
Measured: 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
The content of cffDNA in maternal blood and placenta in Pregnant women with threatened premature delivery.
Measured: at 12 weeks of pregnancy, at 24 weeks of pregnancy, at 36 weeks of pregnancy, at parturition, and at 42 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start28 Mar 2022
- Primary completion28 Mar 2025 (estimated)
- Study completion28 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Yi, Beijing Ditan Hospital
- Investigators
- Wei Yi, Doctor, Study director, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604768
- Sponsor's protocol ID
- KY2022-03
- Status last verified
- Oct 2022
- First submitted
- 14 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Initiation and Immunological Mechanism of Parturition
- ClinicalTrials.gov ID
- NCT05604768
- Acronym / sponsor ID
- KY2022-03
- Conditions
- Pregnancy
- Keywords
- Parturition, Immunity, Myelogenous suppressor cells, Fetal free DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 28 Mar 2025 (estimated)
- Study completion
- 28 Mar 2025 (estimated)
- First posted
- 3 Nov 2022 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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 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 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 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 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.
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.
7 secondary outcomes
The change of the frequency of myeloid-derived suppressor cells (MDSCs) 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
The change of functional molecules expression of myeloid-derived suppressor cells (MDSCs) 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
The change of the frequency of plasmacytoid dendritic cells (pDC) 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
The change of functional molecules expression of plasmacytoid dendritic cells (pDC) 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
The change of frequency of Nature Killer (NK) cells 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
The change of functional molecules expression of Nature Killer (NK) cells 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
The change of the content of cffDNA 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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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.
Wei Yi, Doctor study director
Beijing Ditan Hospital
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 Pregnancy, run by Beijing Ditan Hospital at 1 site in China.
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 1 inclusion and 4 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 3 Nov 2022. 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 China. 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 Wei Yi, Doctor (13683687062, yiwei1215@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2022.