Effects of Recurrent PE on Women and Offspring (RPOH)

The Effects of Recurrent PE on Women and Offspring's Health

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrence; Hypertension; Preeclampsia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

• women with at least twice of delivery history

Exclusion Criteria:

• women with chronic hypertension

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure and hypertension of women	blood pressure ≥140/90 mmHg	1year after the second deliver
blood pressure and hypertension of women	blood pressure ≥140/90 mmHg	3 years after the second deliver
blood pressure and hypertension of women	blood pressure ≥140/90 mmHg	5 years after the second deliver
blood pressure and hypertension of offspring	blood pressure≥140/90 mmHg	1 year old
blood pressure and hypertension of offspring	blood pressure≥140/90 mmHg	3 years old
blood pressure and hypertension of offspring	blood pressure≥140/90 mmHg	5 years old
level of glycosylated hemoglobin in blood	women	1 year after the second deliver
level of glycosylated hemoglobin in blood	women	3 years after the second deliver
level of glycosylated hemoglobin in blood	women	5 years after the second deliver
level of cholesterol, LDL, HDL, VLDL-C in blood	women	1 year after the second deliver
level of cholesterol, LDL, HDL, VLDL-C in blood	women	3 years after the second deliver
level of cholesterol, LDL, HDL, VLDL-C in blood	women	5 years after the second deliver
level of FT3,FT4, and hTSH in blood	women	1year after the second deliver
level of FT3,FT4, and hTSH in blood	women	3 years after the second deliver
level of FT3,FT4, and hTSH in blood	women	5 years after the second deliver
level of AST and ALT in blood	women	1year after the second deliver
level of AST and ALT in blood	women	3 years after the second deliver
level of AST and ALT in blood	women	5 years after the second deliver

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI of offspring	weight(kg)/height(m)2	1 year old
BMI of offspring	weight(kg)/height(m)2	3 years old
BMI of offspring	weight(kg)/height(m)2	5 years old
level of insulin in blood	women	1year after the second deliver
level of insulin in blood	women	3 years after the second deliver
level of insulin in blood	women	5 years after the second deliver
level of fructosamine in blood	women	1year after the second deliver
level of fructosamine in blood	women	3 years after the second deliver
level of fructosamine in blood	women	5 years after the second deliver
level of AI37℃、AI4℃、PRA、ALD、AngII in blood	women	1 year after the second deliver
level of AI37℃、AI4℃、PRA、ALD、AngII in blood	women	3 years after the second deliver
level of AI37℃、AI4℃、PRA、ALD、AngII in blood	women	5 years after the second deliver

Collaborators and Investigators

• Sponsor: Dunjin Chen

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): November 1, 2024
• Study Completion (ANTICIPATED): November 1, 2024

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (ACTUAL): November 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Hypertension, Pregnancy-Induced; Recurrence; Pre-Eclampsia
• Other Study ID Numbers: 81830045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No