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Miscarriage Preventing Herbal Medicines and the Risk of Birth Defects: a Population-based Cohort Study

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ClinicalTrials.gov Identifier: NCT06048276
Recruitment Status : Active, not recruiting
First Posted : September 21, 2023
Last Update Posted : May 7, 2024
Sponsor:
Collaborators:
Xiamen Health Commission
Xiamen Health and Medical Big Data Center
Information provided by (Responsible Party):
Sun Xin, West China Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Pregnancy Birth Defects Drug Exposures Drug: Herbal medicines (e.g., Yunkang granules, Duzhong granules)

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
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Study Type : Observational
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Miscarriage Preventing Herbal Medicines and the Risk of Birth Defects: a Population-based Cohort Study
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Drug exposure
Herbal medicines
 Drug: Herbal medicines (e.g., Yunkang granules, Duzhong granules)
Herbal medicines (e.g., Yunkang granules, Duzhong granules) exposure at the early gestation.


Outcome Measures
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Primary Outcome Measures :
  1. Overall birth defects (excluding chromosomal malformations) [ Time Frame: From conception to 42 days after delivery ]
    Number of births with birth defects


Secondary Outcome Measures :
  1. National monitored 23 main types of birth defects [ Time Frame: From conception to 42 days after delivery ]
    Number of births with 23 major births defects defined by National Health Standard Criteria in the China national universal surveillance system


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All pregnant women registered at the REPRESENT were enrolled.
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Between January 2013 and December 2018, all pregnant women who registered at the REPRESENT in Xiamen was included in this cohort.
Criteria

Inclusion Criteria:

  • Pregnancies registered at REPRESENT and underwent live births between January 2013 and December 2018 were included.

Exclusion Criteria:

  • (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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06048276


Locations
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China, Fujian
Xiamen Health and Medical Big Data Center
Xiamen, Fujian, China, 361008
Sponsors and Collaborators
West China Hospital
Xiamen Health Commission
Xiamen Health and Medical Big Data Center
Investigators
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Study Chair: Xin Sun, PHD Chinese Evidence-based Medicine Center, West China Hospital, Sichuan
More Information
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Responsible Party: Sun Xin, Director of Chinese Evidence-based Medicine Center, West China Hospital
ClinicalTrials.gov Identifier: NCT06048276    
Other Study ID Numbers: HERB and BD
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sun Xin, West China Hospital:
Herbal medicines
Birth defects
Drug exposures
Cohort study
Additional relevant MeSH terms:
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Abortion, Spontaneous
Congenital Abnormalities
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases