RPOH: Effects of Recurrent PE on Women and Offspring

Sponsor
Dunjin Chen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05134285
Collaborator
(none)
1,000
1
34
29.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: blood pressure,BMI, blood sample

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effects of Recurrent PE on Women and Offspring's Health
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
control

pregnancy without preeclampsia

Other: blood pressure,BMI, blood sample
Blood pressure will be monitored. BMI will be measured. Blood samples will be tested.

preeclampsia

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

Other: blood pressure,BMI, blood sample
Blood pressure will be monitored. BMI will be measured. Blood samples will be tested.

recurrent preeclampsia

pregnancy complicated with preeclampsia at two deliveries

Other: blood pressure,BMI, blood sample
Blood pressure will be monitored. BMI will be measured. Blood samples will be tested.

Outcome Measures

Primary Outcome Measures

  1. blood pressure and hypertension of women [1year after the second deliver]

    blood pressure ≥140/90 mmHg

  2. blood pressure and hypertension of women [3 years after the second deliver]

    blood pressure ≥140/90 mmHg

  3. blood pressure and hypertension of women [5 years after the second deliver]

    blood pressure ≥140/90 mmHg

  4. blood pressure and hypertension of offspring [1 year old]

    blood pressure≥140/90 mmHg

  5. blood pressure and hypertension of offspring [3 years old]

    blood pressure≥140/90 mmHg

  6. blood pressure and hypertension of offspring [5 years old]

    blood pressure≥140/90 mmHg

  7. level of glycosylated hemoglobin in blood [1 year after the second deliver]

    women

  8. level of glycosylated hemoglobin in blood [3 years after the second deliver]

    women

  9. level of glycosylated hemoglobin in blood [5 years after the second deliver]

    women

  10. level of cholesterol, LDL, HDL, VLDL-C in blood [1 year after the second deliver]

    women

  11. level of cholesterol, LDL, HDL, VLDL-C in blood [3 years after the second deliver]

    women

  12. level of cholesterol, LDL, HDL, VLDL-C in blood [5 years after the second deliver]

    women

  13. level of FT3,FT4, and hTSH in blood [1year after the second deliver]

    women

  14. level of FT3,FT4, and hTSH in blood [3 years after the second deliver]

    women

  15. level of FT3,FT4, and hTSH in blood [5 years after the second deliver]

    women

  16. level of AST and ALT in blood [1year after the second deliver]

    women

  17. level of AST and ALT in blood [3 years after the second deliver]

    women

  18. level of AST and ALT in blood [5 years after the second deliver]

    women

Secondary Outcome Measures

  1. BMI of offspring [1 year old]

    weight(kg)/height(m)2

  2. BMI of offspring [3 years old]

    weight(kg)/height(m)2

  3. BMI of offspring [5 years old]

    weight(kg)/height(m)2

  4. level of insulin in blood [1year after the second deliver]

    women

  5. level of insulin in blood [3 years after the second deliver]

    women

  6. level of insulin in blood [5 years after the second deliver]

    women

  7. level of fructosamine in blood [1year after the second deliver]

    women

  8. level of fructosamine in blood [3 years after the second deliver]

    women

  9. level of fructosamine in blood [5 years after the second deliver]

    women

  10. level of AI37℃、AI4℃、PRA、ALD、AngII in blood [1 year after the second deliver]

    women

  11. level of AI37℃、AI4℃、PRA、ALD、AngII in blood [3 years after the second deliver]

    women

  12. level of AI37℃、AI4℃、PRA、ALD、AngII in blood [5 years after the second deliver]

    women

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • women with at least twice of delivery history
Exclusion Criteria:
  • women with chronic hypertension

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University Guangzhou China 510150

Sponsors and Collaborators

  • Dunjin Chen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dunjin Chen, Director, Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT05134285
Other Study ID Numbers:
  • 81830045
First Posted:
Nov 24, 2021
Last Update Posted:
Dec 8, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2021