Post Partum Pre-eclampsiaNCT02935556
Characterization and Epigenetics of Post-Partum Preeclampsia
An observational study of Post Partum Pre-eclampsia, run by Duke University at 2 sites in United States.
Trial summary
This study will recruit women with post partum pre-eclampsia and match them to controls without postpartum pre-eclampsia to identify an epigenetic signature that is specific to women with post partum pre-eclampsia to help characterize the underlying pathophysiology of post partum pre-eclampsia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Pre-eclampsia
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2017to 9 Mar 2022
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who present to the hospital with postpartum pre-eclampsia are matched with women who never have PP-PEC (post-partum preeclampsia).
Who may be able to join
- Post partum pre-eclampsia
- Matching based on:
- maternal age (years +/-3)
- BMI (+/-5 points)
- Ethnicity
- Mode of delivery
- Gestational age at delivery (+/7 days)
- Smoking status
Who cannot join
- Intrapartum pre-eclampsia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Columbia University Medical Center
New York, New York, 10023
About this study
This study will recruit women with post partum pre-eclampsia and match them to controls without postpartum pre-eclampsia to identify an epigenetic signature that is specific to women with post partum pre-eclampsia to help characterize the underlying pathophysiology of post partum pre-eclampsia.
Read the detailed description
Preeclampsia (PEC) is a heterogeneous disease that complicates 5-8% of pregnancies. Approximately 10% of PEC patients will present with post-partum PEC without having developed the syndrome during the pregnancy (PP-PEC). Management of post-partum preeclampsia (PP-PEC) is challenging because many women do not seek care until neurologic symptoms result from severe-range elevated blood pressure. The pathogenesis and clinical characteristics of PP-PEC are understudied and poorly understood. Identifying clinical risk factors and biomarkers of PP-PEC would help to identify women at risk.
- Conditions
- Post Partum Pre-eclampsia
- Being tested
- no intervention
- Keywords
- Post Partum Pre-eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
database and epigenetic study
| Study group | Role | What they receive |
|---|---|---|
| post partum pre-eclampsia | women with normal deliveries followed by post partum pre-eclampsia within 1 month of delivery. Receives: Other: no intervention | |
| controls | women with normal deliveries and normal post part courses who match the post partum pre-eclampsia women in age, BMI, smoking status, gestational age and race/ethnicity. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
methylation signature on circulating monocytes
Measured: 1 week post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start1 Feb 2017
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, Society for Obstetric Anesthesia and Perinatology
- Responsible party
- Sponsor
- Investigators
- Marie-Louise Meng, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935556
- Sponsor's protocol ID
- PRO00104636
- Status last verified
- Mar 2024
- First submitted
- 14 Oct 2016
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Epigenetics of Post-Partum Preeclampsia
- ClinicalTrials.gov ID
- NCT02935556
- Acronym / sponsor ID
- PRO00104636
- Conditions
- Post Partum Pre-eclampsia
- Keywords
- Post Partum Pre-eclampsia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- New York University, Society for Obstetric Anesthesia and Perinatology
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 17 Oct 2016 (estimated)
- 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.
This study will recruit women with post partum pre-eclampsia and match them to controls without postpartum pre-eclampsia to identify an epigenetic signature that is specific to women with post partum pre-eclampsia to help characterize the underlying pathophysiology of post partum pre-eclampsia.
Detailed description
Preeclampsia (PEC) is a heterogeneous disease that complicates 5-8% of pregnancies. Approximately 10% of PEC patients will present with post-partum PEC without having developed the syndrome during the pregnancy (PP-PEC). Management of post-partum preeclampsia (PP-PEC) is challenging because many women do not seek care until neurologic symptoms result from severe-range elevated blood pressure. The pathogenesis and clinical characteristics of PP-PEC are understudied and poorly understood. Identifying clinical risk factors and biomarkers of PP-PEC would help to identify women at risk.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post partum pre-eclampsia | – | Other: no interventionwomen with normal deliveries followed by post partum pre-eclampsia within 1 month of delivery. |
| controls | – | Other: no interventionwomen with normal deliveries and normal post part courses who match the post partum pre-eclampsia women in age, BMI, smoking status, gestational age and race/ethnicity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who present to the hospital with postpartum pre-eclampsia are matched with women who never have PP-PEC (post-partum preeclampsia).
Key inclusion criteria (8 listed)
- Post partum pre-eclampsia
- maternal age (years +/-3)
- BMI (+/-5 points)
- Ethnicity
- Mode of delivery
Key exclusion criteria (1 listed)
- Intrapartum pre-eclampsia
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 |
|---|---|---|
| no interventiondatabase and epigenetic study | Other | controls, post partum pre-eclampsia |
Primary outcome
methylation signature on circulating monocytes
Time frame: 1 week post delivery
Results and safety
The study was stopped early (reason given: Low Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Post Partum Pre-eclampsia
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
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A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruitingPhase 4
Biomarkers in Management of Post Partum Preeclampsia
Preeclampsia Severe, Preeclampsia Postpartum
RecruitingPhase 4
Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound
Preeclampsia, Preeclampsia Postpartum
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
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.
Marie-Louise Meng, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Partum Pre-eclampsia, run by Duke University at 2 sites in United States.
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 8 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: stopped early, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study was stopped early (reason given: Low Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
methylation signature on circulating monocytes (time frame: 1 week post delivery). 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 20 Mar 2024.