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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06426732
Other study ID # 2022-919
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date June 30, 2025

Study information

Verified date May 2024
Source The Second Hospital of Shandong University
Contact Wenting Wang, M.D. Ph.D.
Phone +86 17660082326
Email 13188936075@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The incidence of gestational hypertension and preeclampsia in the assisted reproductive technology population during pregnancy was significantly higher than that in the general normal pregnancy population. The use of assisted reproductive technology in this population due to infertility is often accompanied by many hypertension-related factors. We established a prospective cohort study based on assisted reproductive technology pregnancy population and natural pregnancy population. Through continuous monitoring of blood pressure changes and other risk factors during pregnancy in the two groups, we explored the trajectory trend and inflection point of assisted reproductive technology pregnancy population blood pressure during pregnancy. Through factor analysis, the risk factors of elevated blood pressure during pregnancy can be clearly identified, so as to carry out early intervention and strengthen the control of risk factors of elevated blood pressure in assisted reproductive technology population, in order to expect benign maternal and infant outcomes.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date June 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: -Exposure group: Mother: Seen in the obstetrics department of our hospital and meet the following conditions at the same time: 1. Complete at least one cycle of IVF or ICSI, PGD or IVM treatment (including natural cycles); 2. Clinical pregnancy was obtained after treatment. Offspring: Offspring born after in vitro fertilization-embryo transfer technique. - Non-exposed group: Mother: A mother who conceived naturally. Offspring: 1) Offspring born by natural pregnancy. 2) Offspring born from natural pregnancy of exposed mothers. Exclusion Criteria: - Unwilling to participate in this research; - Unable to participate in this study due to special reasons, such as death, immigration, loss to follow-up; - Hereditary diseases, mental diseases, malignant tumors, pre-pregnancy hypertension, uterine malformations and other reproductive organ malformations; - Pregnant women who voluntarily terminate pregnancy due to non-preeclampsia factors;

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Cui linlin Jinan

Sponsors (1)

Lead Sponsor Collaborator
The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females from pregnancy to delivery
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