Parturition; PrecipitateNCT04411745
Capturing Early Events in Human Parturition
An observational study of Parturition; Precipitate, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective observational study on normal singleton pregnant women who have no sign of labor at 40 weeks of gestation or pregnant women who admitted to hospital for any sign of labor at term, aiming to identify labor-associated markers. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parturition; Precipitate
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2016to 31 Dec 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy women who are carrying a healthy singleton pregnancy, but have not yet gone to labor at 40 weeks of gestation or who are at term and admitted to hospital for any sign of labor.
Who may be able to join
- Healthy women who are carrying a healthy singleton pregnancy, but have not yet gone to labor at 40 weeks of gestation or who are at term and admitted to hospital for any sign of labor are invited to join the study.
Who cannot join
- Any obstetric contraindications for undergoing labor or vaginal delivery (e.g. placenta previa, cephalo-pelvic disproportion, macrosomia, previous classical cesarean section or uterine tear, etc).
- Any maternal or fetal complications that require immediate or early delivery (e.g. pre-eclampsia, abruption placenta, fetal distress, rupture of membranes, in utero death, etc).
- Any maternal or fetal complications that make vaginal birth an unfavorable choice (e.g. fetal growth restriction, fetal compromise or distress, etc).
- Any conditions that are known to affect the onset of labor (e.g. anencephaly).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Shatin
Tak Yeung LEUNG, 852-35052806, tyleung@cuhk.edu.hk
About this study
Official title: Capturing Early Events in Human Parturition Based on Whole-transcriptome Analysis of Maternal Blood Before and After Spontaneous Onset of Labor at Term
This is a prospective observational study on normal singleton pregnant women who have no sign of labor at 40 weeks of gestation or pregnant women who admitted to hospital for any sign of labor at term, aiming to identify labor-associated markers.
Read the detailed description
The mechanisms that instigate human parturition have not been completely understood, though hypotheses such as 'functional progesterone withdrawal' and inflammatory signaling have been proposed. Researchers including our group have previously identified panels of genes which were differentially expressed between placentas obtained after spontaneous birth and those after elective cesarean delivery. However, such findings obtained after birth could only reflects the late changes in parturition. Similar findings in other gestational tissues, such as fetal membranes, amniotic fluids, myometrial biopsies are available, but these sample types cannot be readily collected until delivery.
Thus, we propose to explore biomarkers in maternal blood with a view to developing any useful analytes for predicting labor.
- Conditions
- Parturition; Precipitate
- Being tested
- No intervention, observational study
- Keywords
- transcriptome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| Parturition | Healthy women who are carrying a healthy singleton pregnancy, but have not yet gone to labor at 40 weeks of gestation or who are at term and admitted to hospital for any sign of labor. Receives: Other: No intervention, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA gene expression
Peripheral blood samples will be taken for RNA gene expression
Measured: Between 36 and 41 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Dec 2016
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parturition; PrecipitateStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tak Yeung LEUNG, Chinese University of Hong Kong
- Investigators
- Tak Yeung LEUNG, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411745
- Sponsor's protocol ID
- 2015.659
- Status last verified
- Mar 2023
- First submitted
- 28 May 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capturing Early Events in Human Parturition Based on Whole-transcriptome Analysis of Maternal Blood Before and After Spontaneous Onset of Labor at Term
- ClinicalTrials.gov ID
- NCT04411745
- Acronym / sponsor ID
- 2015.659
- Conditions
- Parturition; Precipitate
- Keywords
- transcriptome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Jun 2020 (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 is a prospective observational study on normal singleton pregnant women who have no sign of labor at 40 weeks of gestation or pregnant women who admitted to hospital for any sign of labor at term, aiming to identify labor-associated markers.
Detailed description
The mechanisms that instigate human parturition have not been completely understood, though hypotheses such as 'functional progesterone withdrawal' and inflammatory signaling have been proposed. Researchers including our group have previously identified panels of genes which were differentially expressed between placentas obtained after spontaneous birth and those after elective cesarean delivery. However, such findings obtained after birth could only reflects the late changes in parturition. Similar findings in other gestational tissues, such as fetal membranes, amniotic fluids, myometrial biopsies are available, but these sample types cannot be readily collected until delivery.
Thus, we propose to explore biomarkers in maternal blood with a view to developing any useful analytes for predicting labor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parturition | – | Other: No intervention, observational studyHealthy women who are carrying a healthy singleton pregnancy, but have not yet gone to labor at 40 weeks of gestation or who are at term and admitted to hospital for any sign of labor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy women who are carrying a healthy singleton pregnancy, but have not yet gone to labor at 40 weeks of gestation or who are at term and admitted to hospital for any sign of labor.
Key inclusion criteria (1 listed)
- Healthy women who are carrying a healthy singleton pregnancy, but have not yet gone to labor at 40 weeks of gestation or who are at term and admitted to hospital for any sign of labor are invited to join the study.
Key exclusion criteria (4 listed)
- Any obstetric contraindications for undergoing labor or vaginal delivery (e.g. placenta previa, cephalo-pelvic disproportion, macrosomia, previous classical cesarean section or uterine tear, etc).
- Any maternal or fetal complications that require immediate or early delivery (e.g. pre-eclampsia, abruption placenta, fetal distress, rupture of membranes, in utero death, etc).
- Any maternal or fetal complications that make vaginal birth an unfavorable choice (e.g. fetal growth restriction, fetal compromise or distress, etc).
- Any conditions that are known to affect the onset of labor (e.g. anencephaly).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, observational study | Other | Parturition |
Primary outcome
RNA gene expression
Time frame: Between 36 and 41 weeks of gestation
Peripheral blood samples will be taken for RNA gene expression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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.
Tak Yeung LEUNG, MD principal investigator
Chinese University of Hong Kong
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 Parturition; Precipitate, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 Mar 2023. 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 Hong Kong. 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 Tak Yeung LEUNG, MD (852-35052806, tyleung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RNA gene expression (time frame: Between 36 and 41 weeks of gestation). 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 7 Mar 2023.