PregnancyNCT05620056
A Population-based Study of Drug Exposures and Adverse Pregnancy Outcomes in China (DEEP)
An observational study of Pregnancy and Congenital Malformation, run by West China Hospital at 1 site in China.
Trial summary
The DEEP cohort is the first population-based cohort of pregnant population in China that longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy outcomes. Read more about this study
- Who is it for?
- Ages 14 to 65 years, women only
- Conditions the study is for
- Pregnancy, Congenital Malformation, Drug Exposure
- What is being tested?
- chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs
- How many people
- 564,760 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 1 Nov 2022
- 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: From January 2013, all pregnant women who registered at the Maternal and Child Health Management in Xiamen was included in this cohort.
Who may be able to join
- Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The DEEP cohort is the first population-based cohort of pregnant population in China that longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy outcomes.
Read the detailed description
The DEEP cohort is the first population-based cohort of pregnant population in China that longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy outcomes. The main goal of the study aims to monitor and evaluate the safety of drug use through the pregnancy life course in the Chinese setting. The DEEP cohort is developed primarily based on the population-based data platforms in Xiamen, a municipal city of 5 million population in southeast China. Based on these data platforms, a pregnancy-centered registry was developed that documented health care services and outcomes in the maternal and other departments. For identifying drug uses, a drug prescription database was specifically developed by using electronic healthcare records documented in the platforms across the primary, secondary and tertiary hospitals. By linking the pregnancy registry and prescription database through a unique identifier, the DEEP cohort was developed. All the pregnant women and their offspring in Xiamen are provided with health care and followed up according to standard protocols in the region, including antenatal care, delivery care, postpartum follow-up and childhood follow-ups. The primary adverse outcomes - congenital malformations - are collected using a standardized Case Report Form.
- Conditions
- Pregnancy, Congenital Malformation, Drug Exposure
- Being tested
- chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs
- Keywords
- Cohort study, drug exposures, congenital malformation, pregnancy, population-based
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemicals drugs, biological products, patent Chinese Medicines, Chinese herbsDrug
medication (i.e., chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs ) exposure through the pregnancy life course
| Study group | Role | What they receive |
|---|---|---|
| drug exposure | chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs Receives: Drug: chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
congenital malformations
Number of births with congenital malformations
Measured: up to 42 days after delivery
Secondary outcomes (2)
preterm birth
Number of pregnancies with preterm birth
Measured: up to 37 gestational weeks
low birth weight
Number of live births with low birth weight
Measured: Immediately after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Jan 2013
- Primary completion31 Dec 2021
- Study completion1 Nov 2022
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.
- 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
- Retrospective
- Enrolment
- 564,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Health Commission, Xiamen Health and Medical Big Data Center
- Responsible party
- Principal investigator, Sun Xin, West China Hospital
- Investigators
- Xin Sun, Study chair, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620056
- Sponsor's protocol ID
- DEEP
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population-based Study of Drug Exposures and Adverse Pregnancy Outcomes in China (DEEP)
- ClinicalTrials.gov ID
- NCT05620056
- Acronym / sponsor ID
- DEEP
- Conditions
- Pregnancy, Congenital Malformation, Drug Exposure
- Keywords
- Cohort study, drug exposures, congenital malformation, pregnancy, population-based
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 564,760 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Xiamen Health Commission, Xiamen Health and Medical Big Data Center
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 17 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.
The DEEP cohort is the first population-based cohort of pregnant population in China that longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy outcomes.
Detailed description
The DEEP cohort is the first population-based cohort of pregnant population in China that longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy outcomes. The main goal of the study aims to monitor and evaluate the safety of drug use through the pregnancy life course in the Chinese setting. The DEEP cohort is developed primarily based on the population-based data platforms in Xiamen, a municipal city of 5 million population in southeast China. Based on these data platforms, a pregnancy-centered registry was developed that documented health care services and outcomes in the maternal and other departments. For identifying drug uses, a drug prescription database was specifically developed by using electronic healthcare records documented in the platforms across the primary, secondary and tertiary hospitals. By linking the pregnancy registry and prescription database through a unique identifier, the DEEP cohort was developed. All the pregnant women and their offspring in Xiamen are provided with health care and followed up according to standard protocols in the region, including antenatal care, delivery care, postpartum follow-up and childhood follow-ups. The primary adverse outcomes - congenital malformations - are collected using a standardized Case Report Form.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drug exposure | – | Drug: chemicals drugs, biological products, patent Chinese Medicines, Chinese herbschemicals drugs, biological products, patent Chinese Medicines, Chinese herbs |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From January 2013, all pregnant women who registered at the Maternal and Child Health Management in Xiamen was included in this cohort.
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 |
|---|---|---|
| chemicals drugs, biological products, patent Chinese Medicines, Chinese herbsmedication (i.e., chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs ) exposure through the pregnancy life course | Drug | drug exposure |
Primary outcome
congenital malformations
Time frame: up to 42 days after delivery
Number of births with congenital malformations
2 secondary outcomes
preterm birth
Time frame: up to 37 gestational weeks
low birth weight
Time frame: Immediately after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- 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 study chair
Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China
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 and Congenital Malformation, run by West China 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 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: finished, as of the sponsor's last update on 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
congenital malformations (time frame: up to 42 days after delivery). 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 17 Nov 2022.