PreeclampsiaRPOHNCT05134285
Effects of Recurrent PE on Women and Offspring
An observational study of Preeclampsia and Recurrence, run by Dunjin Chen at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 19 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Recurrence, Hypertension
- What is being tested?
- blood pressure,BMI, blood sample
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2022to Nov 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- women with at least twice of delivery history
Who cannot join
- women with chronic hypertension
Trial locations and contacts
1 site in 1 country.
China1 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
Dunjin Chen
Lili Du
About this study
Official title: 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.
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.
- Conditions
- Preeclampsia, Recurrence, Hypertension
- Being tested
- blood pressure,BMI, blood sample
- Medical subject headings
- Pre-Eclampsia, Recurrence, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure,BMI, blood sampleOther
Blood pressure will be monitored. BMI will be measured. Blood samples will be tested.
| Study group | Role | What they receive |
|---|---|---|
| control | pregnancy without preeclampsia Receives: Other: blood pressure,BMI, blood sample | |
| preeclampsia | pregnancy complicated with preeclampsia at the first delivery or at the second delivery Receives: Other: blood pressure,BMI, blood sample | |
| recurrent preeclampsia | pregnancy complicated with preeclampsia at two deliveries Receives: Other: blood pressure,BMI, blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure and hypertension of women
blood pressure ≥140/90 mmHg
Measured: 1year after the second deliver
blood pressure and hypertension of women
blood pressure ≥140/90 mmHg
Measured: 3 years after the second deliver
blood pressure and hypertension of women
blood pressure ≥140/90 mmHg
Measured: 5 years after the second deliver
blood pressure and hypertension of offspring
blood pressure≥140/90 mmHg
Measured: 1 year old
blood pressure and hypertension of offspring
blood pressure≥140/90 mmHg
Measured: 3 years old
blood pressure and hypertension of offspring
blood pressure≥140/90 mmHg
Measured: 5 years old
level of glycosylated hemoglobin in blood
women
Measured: 1 year after the second deliver
level of glycosylated hemoglobin in blood
women
Measured: 3 years after the second deliver
level of glycosylated hemoglobin in blood
women
Measured: 5 years after the second deliver
level of cholesterol, LDL, HDL, VLDL-C in blood
women
Measured: 1 year after the second deliver
level of cholesterol, LDL, HDL, VLDL-C in blood
women
Measured: 3 years after the second deliver
level of cholesterol, LDL, HDL, VLDL-C in blood
women
Measured: 5 years after the second deliver
level of FT3,FT4, and hTSH in blood
women
Measured: 1year after the second deliver
level of FT3,FT4, and hTSH in blood
women
Measured: 3 years after the second deliver
level of FT3,FT4, and hTSH in blood
women
Measured: 5 years after the second deliver
level of AST and ALT in blood
women
Measured: 1year after the second deliver
level of AST and ALT in blood
women
Measured: 3 years after the second deliver
level of AST and ALT in blood
women
Measured: 5 years after the second deliver
Secondary outcomes (12)
BMI of offspring
weight(kg)/height(m)2
Measured: 1 year old
BMI of offspring
weight(kg)/height(m)2
Measured: 3 years old
BMI of offspring
weight(kg)/height(m)2
Measured: 5 years old
level of insulin in blood
women
Measured: 1year after the second deliver
level of insulin in blood
women
Measured: 3 years after the second deliver
level of insulin in blood
women
Measured: 5 years after the second deliver
level of fructosamine in blood
women
Measured: 1year after the second deliver
level of fructosamine in blood
women
Measured: 3 years after the second deliver
level of fructosamine in blood
women
Measured: 5 years after the second deliver
level of AI37℃、AI4℃、PRA、ALD、AngII in blood
women
Measured: 1 year after the second deliver
level of AI37℃、AI4℃、PRA、ALD、AngII in blood
women
Measured: 3 years after the second deliver
level of AI37℃、AI4℃、PRA、ALD、AngII in blood
women
Measured: 5 years after the second deliver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study startJan 2022 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Dunjin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dunjin Chen, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134285
- Sponsor's protocol ID
- 81830045
- Acronym
- RPOH
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Recurrent PE on Women and Offspring's Health
- ClinicalTrials.gov ID
- NCT05134285
- Acronym / sponsor ID
- RPOH / 81830045
- Conditions
- Preeclampsia, Recurrence, Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dunjin ChenUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | Other: blood pressure,BMI, blood samplepregnancy without preeclampsia |
| preeclampsia | – | Other: blood pressure,BMI, blood samplepregnancy complicated with preeclampsia at the first delivery or at the second delivery |
| recurrent preeclampsia | – | Other: blood pressure,BMI, blood samplepregnancy complicated with preeclampsia at two deliveries |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- women with at least twice of delivery history
Key exclusion criteria (1 listed)
- women with chronic hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood pressure,BMI, blood sampleBlood pressure will be monitored. BMI will be measured. Blood samples will be tested. | Other | control, preeclampsia, recurrent preeclampsia |
Primary outcome
blood pressure and hypertension of women
Time frame: 1year after the second deliver
blood pressure ≥140/90 mmHg
blood pressure and hypertension of women
Time frame: 3 years after the second deliver
blood pressure ≥140/90 mmHg
blood pressure and hypertension of women
Time frame: 5 years after the second deliver
blood pressure ≥140/90 mmHg
blood pressure and hypertension of offspring
Time frame: 1 year old
blood pressure≥140/90 mmHg
blood pressure and hypertension of offspring
Time frame: 3 years old
blood pressure≥140/90 mmHg
blood pressure and hypertension of offspring
Time frame: 5 years old
blood pressure≥140/90 mmHg
level of glycosylated hemoglobin in blood
Time frame: 1 year after the second deliver
women
level of glycosylated hemoglobin in blood
Time frame: 3 years after the second deliver
women
level of glycosylated hemoglobin in blood
Time frame: 5 years after the second deliver
women
level of cholesterol, LDL, HDL, VLDL-C in blood
Time frame: 1 year after the second deliver
women
level of cholesterol, LDL, HDL, VLDL-C in blood
Time frame: 3 years after the second deliver
women
level of cholesterol, LDL, HDL, VLDL-C in blood
Time frame: 5 years after the second deliver
women
level of FT3,FT4, and hTSH in blood
Time frame: 1year after the second deliver
women
level of FT3,FT4, and hTSH in blood
Time frame: 3 years after the second deliver
women
level of FT3,FT4, and hTSH in blood
Time frame: 5 years after the second deliver
women
level of AST and ALT in blood
Time frame: 1year after the second deliver
women
level of AST and ALT in blood
Time frame: 3 years after the second deliver
women
level of AST and ALT in blood
Time frame: 5 years after the second deliver
women
12 secondary outcomes
BMI of offspring
Time frame: 1 year old
BMI of offspring
Time frame: 3 years old
BMI of offspring
Time frame: 5 years old
level of insulin in blood
Time frame: 1year after the second deliver
level of insulin in blood
Time frame: 3 years after the second deliver
level of insulin in blood
Time frame: 5 years after the second deliver
level of fructosamine in blood
Time frame: 1year after the second deliver
level of fructosamine in blood
Time frame: 3 years after the second deliver
level of fructosamine in blood
Time frame: 5 years after the second deliver
level of AI37℃、AI4℃、PRA、ALD、AngII in blood
Time frame: 1 year after the second deliver
level of AI37℃、AI4℃、PRA、ALD、AngII in blood
Time frame: 3 years after the second deliver
level of AI37℃、AI4℃、PRA、ALD、AngII in blood
Time frame: 5 years after the second deliver
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Recurrence, run by Dunjin Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dunjin Chen (18928916722, gzdrchen@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure and hypertension of women (time frame: 1year after the second deliver). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.