PregnancyNCT06048276
Miscarriage Preventing Herbal Medicines and the Risk of Birth Defects: a Population-based Cohort Study
An observational study of Pregnancy and Birth Defects, run by West China Hospital at 1 site in China.
Trial summary
Using data from a population-based medicine use cohort in Xiamen, China, this retrospective cohort study will investigate whether herbal medicines used to prevent miscarriage are associated with increased risk of birth defects. Read more about this study
- Who is it for?
- Ages 15 to 60 years, women only
- Conditions the study is for
- Pregnancy, Birth Defects, Drug Exposures
- What is being tested?
- Herbal medicines (e.g., Yunkang granules, Duzhong granules)
- How many people
- 200,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 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 15 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Between January 2013 and December 2018, all pregnant women who registered at the REPRESENT in Xiamen was included in this cohort.
Who may be able to join
- Pregnancies registered at REPRESENT and underwent live births between January 2013 and December 2018 were included.
Who cannot join
- (1) those with the first antenatal visit occurring after 20 gestational weeks, (2) those without timing records of the last menstrual period or delivery dates, (3) those with known factors related to birth defects (e.g.,syphilis positive, epilepsy), (4) those prescribed known medications associated with birth defects (e.g.,dezocine, diazepam).
Trial locations and contacts
1 site in 1 country.
About this study
Using data from a population-based medicine use cohort in Xiamen, China, this retrospective cohort study will investigate whether herbal medicines used to prevent miscarriage are associated with increased risk of birth defects.
Read the detailed description
Herbal medicines have a long history of use for pregnant women both in China and around the world. However, the safety of herbal medicines used at the early gestation is often questioned regarding their impact on offspring. Therefore, the aim of this study is to investigate whether miscarriage preventing herbal medicines associated with increased risk of birth defects.
A large medication use cohort will be developed by linking a population-based pregnancy registry (i.e., REPRESENT) and a population-based pharmacy database, which documented all prescriptions at both outpatients and inpatients from conception to delivery. This cohort will include herbal medicines formula which were granted approval by the Chinese National Medical Products Administration.
Using data from this cohort, the investigators will investigate the prevalence of the use of herbal medicine formulas and prescription patterns at the first trimester. This study will then investigate the association between miscarriage preventing herbal medicines and the risk of birth defects. A propensity score matching (PSM) based Poisson regression will be used to estimate the relative risk. To ensure the robustness of the results investigators will perform several sensitivity analyses and negative control analyses, such as restricting the population to women with singleton pregnancies, excluding individuals who had undergone in vitro fertilization (IVF), and considering those women who were prescribed herbal medicines during the middle and late stages of pregnancy as the negative exposure control group.
- Conditions
- Pregnancy, Birth Defects, Drug Exposures
- Being tested
- Herbal medicines (e.g., Yunkang granules, Duzhong granules)
- Keywords
- Herbal medicines, Birth defects, Drug exposures, Cohort study
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal medicines (e.g., Yunkang granules, Duzhong granules)Drug
Herbal medicines (e.g., Yunkang granules, Duzhong granules) exposure at the early gestation.
| Study group | Role | What they receive |
|---|---|---|
| Drug exposure | Herbal medicines Receives: Drug: Herbal medicines (e.g., Yunkang granules, Duzhong granules) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall birth defects (excluding chromosomal malformations)
Number of births with birth defects
Measured: From conception to 42 days after delivery
Secondary outcomes (1)
National monitored 23 main types of birth defects
Number of births with 23 major births defects defined by National Health Standard Criteria in the China national universal surveillance system
Measured: From conception to 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 posted21 Sep 2023
- Study start1 Jan 2023
- Primary completion31 Oct 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 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
- 200,000 participants (estimated)
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, PHD, Study chair, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048276
- Sponsor's protocol ID
- HERB and BD
- Status last verified
- May 2024
- First submitted
- 14 Sep 2023
- Last updated
- 7 May 2024
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miscarriage Preventing Herbal Medicines and the Risk of Birth Defects: a Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT06048276
- Acronym / sponsor ID
- HERB and BD
- Conditions
- Pregnancy, Birth Defects, Drug Exposures
- Keywords
- Herbal medicines, Birth defects, Drug exposures, Cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Xiamen Health Commission, Xiamen Health and Medical Big Data Center
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Sep 2023 (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.
Using data from a population-based medicine use cohort in Xiamen, China, this retrospective cohort study will investigate whether herbal medicines used to prevent miscarriage are associated with increased risk of birth defects.
Detailed description
Herbal medicines have a long history of use for pregnant women both in China and around the world. However, the safety of herbal medicines used at the early gestation is often questioned regarding their impact on offspring. Therefore, the aim of this study is to investigate whether miscarriage preventing herbal medicines associated with increased risk of birth defects.
A large medication use cohort will be developed by linking a population-based pregnancy registry (i.e., REPRESENT) and a population-based pharmacy database, which documented all prescriptions at both outpatients and inpatients from conception to delivery. This cohort will include herbal medicines formula which were granted approval by the Chinese National Medical Products Administration.
Using data from this cohort, the investigators will investigate the prevalence of the use of herbal medicine formulas and prescription patterns at the first trimester. This study will then investigate the association between miscarriage preventing herbal medicines and the risk of birth defects. A propensity score matching (PSM) based Poisson regression will be used to estimate the relative risk. To ensure the robustness of the results investigators will perform several sensitivity analyses and negative control analyses, such as restricting the population to women with singleton pregnancies, excluding individuals who had undergone in vitro fertilization (IVF), and considering those women who were prescribed herbal medicines during the middle and late stages of pregnancy as the negative exposure control group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug exposure | – | Drug: Herbal medicines (e.g., Yunkang granules, Duzhong granules)Herbal medicines |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Between January 2013 and December 2018, all pregnant women who registered at the REPRESENT in Xiamen was included in this cohort.
Key inclusion criteria (1 listed)
- Pregnancies registered at REPRESENT and underwent live births between January 2013 and December 2018 were included.
Key exclusion criteria (1 listed)
- (1) those with the first antenatal visit occurring after 20 gestational weeks, (2) those without timing records of the last menstrual period or delivery dates, (3) those with known factors related to birth defects (e.g.,syphilis positive, epilepsy), (4) those prescribed known medications associated with birth defects (e.g.,dezocine, diazepam).
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 |
|---|---|---|
| Herbal medicines (e.g., Yunkang granules, Duzhong granules)Herbal medicines (e.g., Yunkang granules, Duzhong granules) exposure at the early gestation. | Drug | Drug exposure |
Primary outcome
Overall birth defects (excluding chromosomal malformations)
Time frame: From conception to 42 days after delivery
Number of births with birth defects
1 secondary outcome
National monitored 23 main types of birth defects
Time frame: From conception to 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 7 May 2024.
- 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 chair
Chinese Evidence-based Medicine Center, West China Hospital, Sichuan
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 Birth Defects, 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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?
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?
Overall birth defects (excluding chromosomal malformations) (time frame: From conception 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 7 May 2024.