CClinicalTrials.gg
Status unknownNCT05134285RPOHUpdated Dec 8, 2021

Effects of Recurrent PE on Women and Offspring

An observational study in Preeclampsia, Recurrence and Hypertension, sponsored by Dunjin Chen. Status unknown at 1 site in China. Open to female participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-08.

Sponsored by Dunjin Chen · Observational

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,000
Ages
19 Years to 50 Years
Sex
Female
01

Study summary

The purpose of this study is to evaluate the risk factors of recurrent preeclampsia and compare the short-term and long-term adverse outcomes of women and their offspring.

Read the detailed description

The investigators collected women delivered twice in a row in our hospital. The investigators divided these pregnant women into three groups. Women in the first group did not complicate preeclampsia at both deliveries; Women in the second group complicated preeclampsia at the first delivery or at the second delivery; women in the third group complicated preeclampsia at two deliveries. The investigators explore the risk factors of recurrent preeclampsia and measure blood pressure, blood lipids, thyroid function, glycosylated hemoglobin, ALT, AST, et al. in one year, three years, and five years after the second delivery.

02

Conditions studied

  • Preeclampsia
  • Recurrence
  • Hypertension
03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Dunjin Chen is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

women with at least twice of delivery history are divided into three groups, control group refers to women without preeclampsia history, the second group refers to women complicated with preeclampsia at the first delivery or at the second delivery, the third group refers to women complicated with preeclampsia at two deliveries.

Inclusion criteria

  • women with at least twice of delivery history

Exclusion criteria

Exclusion Criteria:

  • women with chronic hypertension
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • control

    pregnancy without preeclampsia

    Other: blood pressure,BMI, blood sample

  • preeclampsia

    pregnancy complicated with preeclampsia at the first delivery or at the second delivery

    Other: blood pressure,BMI, blood sample

  • recurrent preeclampsia

    pregnancy complicated with preeclampsia at two deliveries

    Other: blood pressure,BMI, blood sample

Interventions

  • Otherblood pressure,BMI, blood sample

    Blood pressure will be monitored. BMI will be measured. Blood samples will be tested.

06

What researchers measure

Primary outcomes

  1. blood pressure and hypertension of women

    blood pressure ≥140/90 mmHg

    Time frame: 1year after the second deliver

  2. blood pressure and hypertension of women

    blood pressure ≥140/90 mmHg

    Time frame: 3 years after the second deliver

  3. blood pressure and hypertension of women

    blood pressure ≥140/90 mmHg

    Time frame: 5 years after the second deliver

  4. blood pressure and hypertension of offspring

    blood pressure≥140/90 mmHg

    Time frame: 1 year old

  5. blood pressure and hypertension of offspring

    blood pressure≥140/90 mmHg

    Time frame: 3 years old

  6. blood pressure and hypertension of offspring

    blood pressure≥140/90 mmHg

    Time frame: 5 years old

  7. level of glycosylated hemoglobin in blood

    women

    Time frame: 1 year after the second deliver

  8. level of glycosylated hemoglobin in blood

    women

    Time frame: 3 years after the second deliver

  9. level of glycosylated hemoglobin in blood

    women

    Time frame: 5 years after the second deliver

  10. level of cholesterol, LDL, HDL, VLDL-C in blood

    women

    Time frame: 1 year after the second deliver

  11. level of cholesterol, LDL, HDL, VLDL-C in blood

    women

    Time frame: 3 years after the second deliver

  12. level of cholesterol, LDL, HDL, VLDL-C in blood

    women

    Time frame: 5 years after the second deliver

  13. level of FT3,FT4, and hTSH in blood

    women

    Time frame: 1year after the second deliver

  14. level of FT3,FT4, and hTSH in blood

    women

    Time frame: 3 years after the second deliver

  15. level of FT3,FT4, and hTSH in blood

    women

    Time frame: 5 years after the second deliver

  16. level of AST and ALT in blood

    women

    Time frame: 1year after the second deliver

  17. level of AST and ALT in blood

    women

    Time frame: 3 years after the second deliver

  18. level of AST and ALT in blood

    women

    Time frame: 5 years after the second deliver

Secondary outcomes

  1. BMI of offspring

    weight(kg)/height(m)2

    Time frame: 1 year old

  2. BMI of offspring

    weight(kg)/height(m)2

    Time frame: 3 years old

  3. BMI of offspring

    weight(kg)/height(m)2

    Time frame: 5 years old

  4. level of insulin in blood

    women

    Time frame: 1year after the second deliver

  5. level of insulin in blood

    women

    Time frame: 3 years after the second deliver

  6. level of insulin in blood

    women

    Time frame: 5 years after the second deliver

  7. level of fructosamine in blood

    women

    Time frame: 1year after the second deliver

  8. level of fructosamine in blood

    women

    Time frame: 3 years after the second deliver

  9. level of fructosamine in blood

    women

    Time frame: 5 years after the second deliver

  10. level of AI37℃、AI4℃、PRA、ALD、AngII in blood

    women

    Time frame: 1 year after the second deliver

  11. level of AI37℃、AI4℃、PRA、ALD、AngII in blood

    women

    Time frame: 3 years after the second deliver

  12. level of AI37℃、AI4℃、PRA、ALD、AngII in blood

    women

    Time frame: 5 years after the second deliver

07

Study locations

1 site
  • Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University
    Guangzhou, 510150, China
    • Dunjin Chen · Contact
    • Lili Du · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05134285
Lead sponsor
Dunjin Chen
Responsible party
Dunjin Chen (Director, Guangzhou Medical University) — Sponsor-investigator
First posted
Nov 24, 2021
Start date
Jan 2022 (estimated)
Primary completion
Nov 2024 (estimated)
Completion
Nov 2024 (estimated)
Last update
Dec 8, 2021

Study contacts

Dunjin Chen
Contact
gzdrchen@gzhmu.edu.cn
18928916722

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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