Congenital MalformationsNCT06770465
Maternal Use of Antibiotics and the Risk of Congenital Malformations
An observational study of Congenital Malformations, run by West China Hospital at 1 site in China.
Trial summary
Antibiotics are widely used during pregnancy to prevent or treat infections, yet concerns remain regarding their fetal safety. Drawing on data from spontaneous reporting databases and cohort studies, this study aims to explore potential associations between exposure to various antibiotic classes during pregnancy and… Read more about this study
- Who is it for?
- Ages 14 to 65 years, women only
- Conditions the study is for
- Congenital Malformations
- What is being tested?
- Different categories of antibiotics
- How many people
- 850,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: For the spontaneous reporting studies, the study population was pregnant women who reported an adverse medication event during the study period, where the exposed population was pregnant women who reported an adverse event due to the use of a different type of antibiotic during the study period. For cohort studies, the study population was women who were pregnant during the study period and the exposed population was pregnant women who used different types of antibiotics during the study period
Who may be able to join
- For the spontaneous reporting data study, all adverse reactions reported by mothers were included.
- For the cohort study, all Xiamen pregnant women registered in the cohort were included
Who cannot join
- For studies using spontaneous reporting data, all adverse reaction reports unrelated to pregnant or postpartum women-including those occurring during the lactation period-were excluded.
- For cohort studies, pregnant women who were lost to follow-up were excluded, and pregnant women who were exposed to factors known to be associated with congenital malformations were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
The West China Hospital of Sichuan university
Chengdu, Sichuan, 610041
About this study
Official title: Maternal Use of Antibiotics and the Risk of Congenital Malformations: a Study Using Spontaneous Reporting Data and a Population-based Cohort Data From the US, Canada and China
Antibiotics are widely used during pregnancy to prevent or treat infections, yet concerns remain regarding their fetal safety. Drawing on data from spontaneous reporting databases and cohort studies, this study aims to explore potential associations between exposure to various antibiotic classes during pregnancy and congenital malformations.
Data were collected from publicly available reports in the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS), the Canada Vigilance Adverse Reaction (CVAR) database, and a population-based retrospective cohort in Xiamen, China. By applying multiple signal detection methods, we identified potential risk signals linking different antibiotic classes to organ-system-specific congenital malformations. For antibiotics showing positive signals, we further utilized a pregnancy medication cohort in Xiamen and applied causal inference techniques to estimate the adjusted relative risk of congenital malformations associated with first-trimester exposure to these antibiotics. Several sensitivity analyses-including both negative- and positive-control analyses-will also be performed.
- Conditions
- Congenital Malformations
- Being tested
- Different categories of antibiotics
- Keywords
- Antibiotic; Congenital malformation; Pregnancy; Spontaneous report; Cohort
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different categories of antibioticsDrug
Use of different categories of antibiotics during pregnancy, such as quinolones and macrolides.
| Study group | Role | What they receive |
|---|---|---|
| Use of antibiotics during pregnancy in FAERS and CVAR databases | When using the publicly available spontaneous adverse event reporting databases FAERS and CVAR, the exposure group consists of reports of adverse events in pregnant individuals who used different types of antibiotics, and the control group consists of other adverse event reports in which no antibiotics were used. Receives: Drug: Different categories of antibiotics | |
| Use of antibiotics during pregnancy in a cohort in Xiamen, China | When using the pregnant women cohort data from Xiamen, China, the exposure group consists of pregnant individuals who used the target antibiotics of interest, while the control group is either those who did not use any antibiotics (blank control) or those who used penicillin (positive control). Receives: Drug: Different categories of antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Congenital malformations
This study categorizes congenital malformation adverse events into 10 organ system specific congenital malformation (Q00-Q89) based on ICQ-10. Additionally, the cohort detected 22 congenital malformations mandated for surveillance in China and generated a composite outcome of total congenital malformation, that was a combination of all the above congenital anomalies.
Measured: From pregnancy 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 posted13 Jan 2025
- Study start1 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital MalformationsStudies 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
- 850,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Xin, West China Hospital
- Investigators
- Xin Sun, PhD, Study chair, Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770465
- Sponsor's protocol ID
- Antibiotics and BDs
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Use of Antibiotics and the Risk of Congenital Malformations: a Study Using Spontaneous Reporting Data and a Population-based Cohort Data From the US, Canada and China
- ClinicalTrials.gov ID
- NCT06770465
- Acronym / sponsor ID
- Antibiotics and BDs
- Conditions
- Congenital Malformations
- Keywords
- Antibiotic; Congenital malformation; Pregnancy; Spontaneous report; Cohort
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 850,000 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Jan 2025 (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.
Antibiotics are widely used during pregnancy to prevent or treat infections, yet concerns remain regarding their fetal safety. Drawing on data from spontaneous reporting databases and cohort studies, this study aims to explore potential associations between exposure to various antibiotic classes during pregnancy and congenital malformations.
Data were collected from publicly available reports in the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS), the Canada Vigilance Adverse Reaction (CVAR) database, and a population-based retrospective cohort in Xiamen, China. By applying multiple signal detection methods, we identified potential risk signals linking different antibiotic classes to organ-system-specific congenital malformations. For antibiotics showing positive signals, we further utilized a pregnancy medication cohort in Xiamen and applied causal inference techniques to estimate the adjusted relative risk of congenital malformations associated with first-trimester exposure to these antibiotics. Several sensitivity analyses-including both negative- and positive-control analyses-will also be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of antibiotics during pregnancy in FAERS and CVAR databases | – | Drug: Different categories of antibioticsWhen using the publicly available spontaneous adverse event reporting databases FAERS and CVAR, the exposure group consists of reports of adverse events in pregnant individuals who used different types of antibiotics, and the control group consists of other adverse event reports in which no antibiotics were used. |
| Use of antibiotics during pregnancy in a cohort in Xiamen, China | – | Drug: Different categories of antibioticsWhen using the pregnant women cohort data from Xiamen, China, the exposure group consists of pregnant individuals who used the target antibiotics of interest, while the control group is either those who did not use any antibiotics (blank control) or those who used penicillin (positive control). |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For the spontaneous reporting studies, the study population was pregnant women who reported an adverse medication event during the study period, where the exposed population was pregnant women who reported an adverse event due to the use of a different type of antibiotic during the study period. For cohort studies, the study population was women who were pregnant during the study period and the exposed population was pregnant women who used different types of antibiotics during the study period
Key inclusion criteria (2 listed)
- For the spontaneous reporting data study, all adverse reactions reported by mothers were included.
- For the cohort study, all Xiamen pregnant women registered in the cohort were included
Key exclusion criteria (2 listed)
- For studies using spontaneous reporting data, all adverse reaction reports unrelated to pregnant or postpartum women-including those occurring during the lactation period-were excluded.
- For cohort studies, pregnant women who were lost to follow-up were excluded, and pregnant women who were exposed to factors known to be associated with congenital malformations were excluded.
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 |
|---|---|---|
| Different categories of antibioticsUse of different categories of antibiotics during pregnancy, such as quinolones and macrolides. | Drug | Use of antibiotics during pregnancy in FAERS and CVAR databases, Use of antibiotics during pregnancy in a cohort in Xiamen, China |
Primary outcome
Congenital malformations
Time frame: From pregnancy to 42 days after delivery
This study categorizes congenital malformation adverse events into 10 organ system specific congenital malformation (Q00-Q89) based on ICQ-10. Additionally, the cohort detected 22 congenital malformations mandated for surveillance in China and generated a composite outcome of total congenital malformation, that was a combination of all the above congenital anomalies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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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 of Sichuan University
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 Congenital Malformations, 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: From pregnancy 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 13 Jan 2025.