---
title: Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes
nct_id: NCT06180447
overall_status: ACTIVE_NOT_RECRUITING
sponsor: Sun Xin
study_type: OBSERVATIONAL
primary_condition: Vaccine Adverse Reaction
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06180447.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06180447"
ct_last_update_post_date: 2024-05-07
last_seen_at: "2026-05-12T07:30:11.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes

**NCT ID:** [NCT06180447](https://clinicaltrials.gov/study/NCT06180447)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 150000
- **Lead Sponsor:** Sun Xin
- **Conditions:** Vaccine Adverse Reaction
- **Start Date:** 2024-01-01
- **Completion Date:** 2025-03-30
- **CT.gov Last Update:** 2024-05-07

## Brief Summary

Uing data from a population based cohort in China, we will conduct retrospective cohort study to evaluate the risk of vaccine (e.g., HPV/influenza/rabies vaccine) administered during pregnancy (especially during first trimester) for adverse pregnancy outcomes (e.g., birth defects, preterm birth and low birth weight)

## Detailed Description

We will develop a vaccination cohort by linking population-based pregnancy registries (i.e., REPRESENT) with population-based vaccine databases.

The researchers will use data from this cohort to examine vaccine use 90 days before the last menstrual period and throughout pregnancy. This study will investigate whether maternal vaccination during pregnancy is associated with the risk of adverse pregnancy outcomes. Poisson regression based on propensity scores will be used to estimate the relative risk. To ensure the robustness of the results, the researchers will perform several sensitivity analyses and negative control analyses, such as the risk of adverse pregnancy outcomes in pregnant women who have been vaccinated several times and pregnant women who have been vaccinated in mid and late pregnancy as negative control groups.

## Eligibility

- **Minimum age:** 14 Years
- **Maximum age:** 65 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* All pregnant women in Xiamen who registry in our database.

Exclusion Criteria:

* Pregnant women who were lost to follow-up. Pregnant women exposed to related factors of known congenital malformation.
```

## Interventions

- **Hepatitis B vaccine, rabies vaccine, HPV vaccine, influenza vaccine** (BIOLOGICAL) — Exposure was defined as use of the vaccine 90 days before the last menstrual period and during pregnancy.

## Primary Outcomes

- **Birth defects** _(time frame: From pregnancy to 42 days after delivery)_ — BDs were defined as any prenatal malformation (including structural, functional, or metabolic disorders) diagnosed through systematic ultrasound or genetic testing during pregnancy and any malformation diagnosed by clinicians within 42 days of birth，which were coded according to the International Classification of Diseases, Tenth Revision (ICD-10) (Q00-Q99).

## Secondary Outcomes

- **Incidence of Adverse pregnancy outcomes** _(time frame: From pregnancy to 42 days after delivery)_

## Locations (1)

- The West China Hospital of Sichuan university, Chengdu, Sichuan, China

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `locations.the west china hospital of sichuan university|chengdu|sichuan|china` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06180447*  
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