Pregnant WomenNCT04222621
Xiamen Registry of Pregnant Women and Offspring (REPRESENT)
An observational study of Pregnant Women and Registries, run by West China Hospital.
Trial summary
To improve the health of women and children under the background of Healthy China 2030, the investigators developed REPRESENT by establishing a pregnancy registry in Xiamen, a sub-provincial city of over four million residents in east China, based on the Maternal and Child Health Management Platform, and then linking… Read more about this study
- Who is it for?
- Ages 14 to 65 years, women only
- Conditions the study is for
- Pregnant Women, Registries
- What is being tested?
- Pregnant women without intervention
- How many people
- 761,194 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Dec 2023
- How long will I take part?
- 7 Years
- 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 14 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.
Who may be able to join
- Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.
Who cannot join
- None.
About this study
Official title: Xiamen Registry of Pregnant Women and Offspring (REPRESENT): A Population-based, Long-term Follow-up Database Linking Four Major Healthcare Data Platforms
To improve the health of women and children under the background of Healthy China 2030, the investigators developed REPRESENT by establishing a pregnancy registry in Xiamen, a sub-provincial city of over four million residents in east China, based on the Maternal and Child Health Management Platform, and then linking to three other platforms, i.e. Residents Healthcare Management Platform, Primary Healthcare Management Platform, and Electronic Healthcare Records (EHR) Platform, which had been developed since 2006. The registry documented information and events about pregnant women from registration at their first trimester to postpartum, and includes the childhood follow up records. The registry not only enables longitudinal follow up of pregnant women and their offspring, but also expands the scope of database from pre-pregnancy exposures to long-term outcomes by data linkage.
During the past 11 years (January 2008 to March 2019), the REPRESENT has accumulated data concerning more than 700 thousands pregnancies. The data volume is substantial with over 800 variables being documented, and most variables are designed as structured fields. The disease categories and codes are standardized according to the International Classification of Diseases 10th Revision (ICD-10). The whole process of data access, data extraction, data processing and data analysis was conducted through an internal-only accessible server at Xiamen Health and Medical Big Data Center. All investigators cannot access sensitive information, are required to sign data confidentiality agreement and should obtain approval by the Xiamen Health and Medical Big Data Center and the Chinese Evidence-based Medicine Center.
- Conditions
- Pregnant Women, Registries
- Being tested
- Pregnant women without intervention
- Keywords
- Population-based healthcare database, Registry, Pregnant women and offspring, Longitudinal study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant women without interventionOther
Pregnant women with those exposures of interest determined in specific research based on the registry
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Not described Receives: Other: Pregnant women without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pre-eclampsia
Maternal systolic blood pressure ≥ 140 mmHg and (or) diastolic pressure ≥ 90 mmHg, accompanied by any one of the following: urinary protein ≥ 0.3g/24 h, or the ratio of urinary protein and creatinine ≥ 0.3, or random urine protein ≥ (+) if quantitative urine protein is not available; no proteinuria but with any damages of heart, lung, liver, kidney and other important organs, or with abnormal changes of blood system, digestive system and nervous system, or placenta fetus involvement, etc.
Measured: Up to 42 weeks
Incidence of eclampsia
Tonic-clonic seizures (convulsions) in preeclampsia patients, including convulsions and coma, not due to pre-existing or organic brain disorders.
Measured: Up to 42 weeks
Incidence of gestational diabetes
By oral glucose tolerance test between 24 and 28 gestational weeks (fasting glucose ≥5.1 mmol/L, 1-h glucose ≥10.0 mmol/L, 2-h glucose ≥8.5 mmol/L; one abnormal result sufficient).
Measured: Up to 32 weeks
Incidence of ruptured uterus
Rupture of maternal uterus confirmed by laparotomy.
Measured: Up to 42 weeks
Incidence of postpartum hemorrhage
Postpartum bleeding volume ≥500 mL.
Measured: Within 24h after delivery
Incidence of maternal death
Maternal death
Measured: Up to 52 weeks
Incidence of birth defects
Birth defects such as anencephaly, spina bifida, encephalocele, hydrocephalus, cleft palate, cleft lip, microtia, esophageal atresia or stenosis, anorectal, hypospadias, ectropion of bladder, talipes equinovarus, polydactylism, ankylodactylia, congenital diaphragmatic hernia, umbilical cord prolapse, gastroschisis, conjoined twins, down syndrome, congenital heart disease, or other birth defects.
Measured: Up to 7 years
Incidence of preterm birth
Delivery before 37th gestational weeks.
Measured: Up to 37 weeks
Incidence of neonatal birth weight
Neonatal birth weight measured after birth.
Measured: Up to 42 weeks
Incidence of neonatal death
Neonatal death
Measured: Within 28 days after delivery
Incidence of stillbirth
Fetus death at or after 20-28 weeks of gestation.
Measured: Up to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study startJan 2008
- Primary completionMar 2019
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- 761,194 participants (actual)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Health and Medical Big Data Center, Xiamen Health Commission
- Responsible party
- Principal investigator, Sun Xin, West China Hospital
- Investigators
- Xin Sun, PhD, Study director, Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222621
- Sponsor's protocol ID
- REPRESENT
- Status last verified
- Jan 2020
- First submitted
- 27 Dec 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following the policy of Xiamen Health Commission, research institutions could apply for data access by submitting a formal study protocol, subjected to approval by the Xiamen Health and Medical Big Data Center and the Chinese Evidence-based Medicine Center. Ethical review and research registration are mandatory for all studies.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xiamen Registry of Pregnant Women and Offspring (REPRESENT): A Population-based, Long-term Follow-up Database Linking Four Major Healthcare Data Platforms
- ClinicalTrials.gov ID
- NCT04222621
- Acronym / sponsor ID
- REPRESENT
- Conditions
- Pregnant Women, Registries
- Keywords
- Population-based healthcare database, Registry, Pregnant women and offspring, Longitudinal study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 761,194 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Xiamen Health and Medical Big Data Center, Xiamen Health Commission
- Study start
- Jan 2008 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Jan 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.
To improve the health of women and children under the background of Healthy China 2030, the investigators developed REPRESENT by establishing a pregnancy registry in Xiamen, a sub-provincial city of over four million residents in east China, based on the Maternal and Child Health Management Platform, and then linking to three other platforms, i.e. Residents Healthcare Management Platform, Primary Healthcare Management Platform, and Electronic Healthcare Records (EHR) Platform, which had been developed since 2006. The registry documented information and events about pregnant women from registration at their first trimester to postpartum, and includes the childhood follow up records. The registry not only enables longitudinal follow up of pregnant women and their offspring, but also expands the scope of database from pre-pregnancy exposures to long-term outcomes by data linkage.
During the past 11 years (January 2008 to March 2019), the REPRESENT has accumulated data concerning more than 700 thousands pregnancies. The data volume is substantial with over 800 variables being documented, and most variables are designed as structured fields. The disease categories and codes are standardized according to the International Classification of Diseases 10th Revision (ICD-10). The whole process of data access, data extraction, data processing and data analysis was conducted through an internal-only accessible server at Xiamen Health and Medical Big Data Center. All investigators cannot access sensitive information, are required to sign data confidentiality agreement and should obtain approval by the Xiamen Health and Medical Big Data Center and the Chinese Evidence-based Medicine Center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Pregnant women without intervention |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.
Key inclusion criteria (1 listed)
- Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Pregnant women without interventionPregnant women with those exposures of interest determined in specific research based on the registry | Other | Pregnant women |
Primary outcome
Incidence of pre-eclampsia
Time frame: Up to 42 weeks
Maternal systolic blood pressure ≥ 140 mmHg and (or) diastolic pressure ≥ 90 mmHg, accompanied by any one of the following: urinary protein ≥ 0.3g/24 h, or the ratio of urinary protein and creatinine ≥ 0.3, or random urine protein ≥ (+) if quantitative urine protein is not available; no proteinuria but with any damages of heart, lung, liver, kidney and other important organs, or with abnormal changes of blood system, digestive system and nervous system, or placenta fetus involvement, etc.
Incidence of eclampsia
Time frame: Up to 42 weeks
Tonic-clonic seizures (convulsions) in preeclampsia patients, including convulsions and coma, not due to pre-existing or organic brain disorders.
Incidence of gestational diabetes
Time frame: Up to 32 weeks
By oral glucose tolerance test between 24 and 28 gestational weeks (fasting glucose ≥5.1 mmol/L, 1-h glucose ≥10.0 mmol/L, 2-h glucose ≥8.5 mmol/L; one abnormal result sufficient).
Incidence of ruptured uterus
Time frame: Up to 42 weeks
Rupture of maternal uterus confirmed by laparotomy.
Incidence of postpartum hemorrhage
Time frame: Within 24h after delivery
Postpartum bleeding volume ≥500 mL.
Incidence of maternal death
Time frame: Up to 52 weeks
Maternal death
Incidence of birth defects
Time frame: Up to 7 years
Birth defects such as anencephaly, spina bifida, encephalocele, hydrocephalus, cleft palate, cleft lip, microtia, esophageal atresia or stenosis, anorectal, hypospadias, ectropion of bladder, talipes equinovarus, polydactylism, ankylodactylia, congenital diaphragmatic hernia, umbilical cord prolapse, gastroschisis, conjoined twins, down syndrome, congenital heart disease, or other birth defects.
Incidence of preterm birth
Time frame: Up to 37 weeks
Delivery before 37th gestational weeks.
Incidence of neonatal birth weight
Time frame: Up to 42 weeks
Neonatal birth weight measured after birth.
Incidence of neonatal death
Time frame: Within 28 days after delivery
Neonatal death
Incidence of stillbirth
Time frame: Up to 42 weeks
Fetus death at or after 20-28 weeks of gestation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Individual participant dataSharing planned: Yes. Following the policy of Xiamen Health Commission, research institutions could apply for data access by submitting a formal study protocol, subjected to approval by the Xiamen Health and Medical Big Data Center and the Chinese Evidence-based Medicine Center. Ethical review and research registration are mandatory for all studies.
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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.
Xin Sun, PhD study director
Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women and Registries, run by West China Hospital.
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 1 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 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pre-eclampsia (time frame: Up to 42 weeks). The study lists 11 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 10 Jan 2020.