Clinical trial NCT05134285: Effects of Recurrent PE on Women and Offspring
Official title: The Effects of Recurrent PE on Women and Offspring's Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Recurrence
Hypertension
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* women with at least twice of delivery history

Exclusion Criteria:

* women with chronic hypertension

Primary outcomes:
measure: blood pressure and hypertension of women
timeFrame: 1year after the second deliver
measure: blood pressure and hypertension of women
timeFrame: 3 years after the second deliver
measure: blood pressure and hypertension of women
timeFrame: 5 years after the second deliver
measure: blood pressure and hypertension of offspring
timeFrame: 1 year old
measure: blood pressure and hypertension of offspring
timeFrame: 3 years old
measure: blood pressure and hypertension of offspring
timeFrame: 5 years old
measure: level of glycosylated hemoglobin in blood
timeFrame: 1 year after the second deliver
measure: level of glycosylated hemoglobin in blood
timeFrame: 3 years after the second deliver
measure: level of glycosylated hemoglobin in blood
timeFrame: 5 years after the second deliver
measure: level of cholesterol, LDL, HDL, VLDL-C in blood
timeFrame: 1 year after the second deliver
measure: level of cholesterol, LDL, HDL, VLDL-C in blood
timeFrame: 3 years after the second deliver
measure: level of cholesterol, LDL, HDL, VLDL-C in blood
timeFrame: 5 years after the second deliver
measure: level of FT3,FT4, and hTSH in blood
timeFrame: 1year after the second deliver
measure: level of FT3,FT4, and hTSH in blood
timeFrame: 3 years after the second deliver
measure: level of FT3,FT4, and hTSH in blood
timeFrame: 5 years after the second deliver
measure: level of AST and ALT in blood
timeFrame: 1year after the second deliver
measure: level of AST and ALT in blood
timeFrame: 3 years after the second deliver
measure: level of AST and ALT in blood
timeFrame: 5 years after the second deliver
Secondary outcomes:
measure: BMI of offspring
timeFrame: 1 year old
measure: BMI of offspring
timeFrame: 3 years old
measure: BMI of offspring
timeFrame: 5 years old
measure: level of insulin in blood
timeFrame: 1year after the second deliver
measure: level of insulin in blood
timeFrame: 3 years after the second deliver
measure: level of insulin in blood
timeFrame: 5 years after the second deliver
measure: level of fructosamine in blood
timeFrame: 1year after the second deliver
measure: level of fructosamine in blood
timeFrame: 3 years after the second deliver
measure: level of fructosamine in blood
timeFrame: 5 years after the second deliver
measure: level of AI37℃、AI4℃、PRA、ALD、AngII in blood
timeFrame: 1 year after the second deliver
measure: level of AI37℃、AI4℃、PRA、ALD、AngII in blood
timeFrame: 3 years after the second deliver
measure: level of AI37℃、AI4℃、PRA、ALD、AngII in blood
timeFrame: 5 years after the second deliver
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University
Study officials:
References: