PreeclampsiaNCT00719537
Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
A study testing Aspirin and Progesterone in people with Preeclampsia, run by John Uckele at 1 site in United States.
Trial summary
This study investigates whether low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Aspirin and Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant patients with a previous history of preeclampsia in the immediate preceding pregnancy.
- 18 to 45 years of age will be included.
Who cannot join
- Patients with chronic hypertension
- children (age < 17 years)
- Patients that are currently taking anti-psychotics or Selective Serotonin Re-uptake Inhibitors
- patients on medications which may be detrimental to the study interpretation will also be excluded at the principal investigator's discretion.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia in Patients With a Prior History of Preeclampsia: A Prospective, Randomized Clinical Trial
This study investigates whether low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy.
Read the detailed description
Recent advances have shown that certain proteins may be present in a pregnant woman's blood very early in pregnancy which can predict who is at the highest risk for developing preeclampsia. These proteins can be measured and may be used to predict a woman's risk of developing preeclampsia.
Special placental cells called endovascular cytotrophoblasts are needed in the early formation of the placenta. These placental cells invade the maternal blood vessels in the formation of the maternal-placental blood interface. Human Leukocytes Antigen-G (HLA-G) is a protein produced by the placental cells and prevents these special cells from being rejected by the mother's immune system. Recent studies have indicated that the level of HLA-G is decreased in placentas from mothers with preeclampsia. Progesterone, a naturally occurring hormone produced in pregnancy, has been shown to increase the production of HLA-G in the placental cytotrophoblast cells.
In regards to the treatment of preeclampsia, studies have shown that low dose aspirin if given to mothers who have had severe early preeclampsia, lowers the risk for having preeclampsia again. This study aims to show that low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy. Data generated will determine levels and ratios of blood proteins that are predictive of preeclampsia at specific gestational ages.
- Conditions
- Preeclampsia
- Being tested
- Aspirin, Placebo Oral Tablet, Progesterone
- Keywords
- preeclampsia, progesterone, aspirin, prevent, soluble fms-like tyrosine kinase (sFlt-1), Placental Growth Factor (PlGF), risk
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin 81 mg once a day
Placebo Oral TabletDrug
Placebo 1 tab Daily
ProgesteroneDrug
Oral Progesterone 200 mg Twice Daily
| Study group | Role | What they receive |
|---|---|---|
| Aspirin plus Placebo Oral Tablet | Placebo comparator | Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day Receives: Drug: Aspirin; Drug: Placebo Oral Tablet |
| Aspirin plus Progesterone | Active comparator | Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day Receives: Drug: Aspirin; Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Preeclampsia
Number of Participants with preeclampsia in second and third trimester of pregnancy.
Measured: second and third trimester of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: inability to find qualifying participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Uckele
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Uckele, Corewell Health East
- Investigators
- John E Uckele, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719537
- Sponsor's protocol ID
- 2008-054
- Status last verified
- Mar 2017
- First submitted
- 17 Jul 2008
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No study data is available, will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia in Patients With a Prior History of Preeclampsia: A Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00719537
- Acronym / sponsor ID
- 2008-054
- Conditions
- Preeclampsia
- Keywords
- preeclampsia, progesterone, aspirin, prevent, soluble fms-like tyrosine kinase (sFlt-1), Placental Growth Factor (PlGF), risk
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to find qualifying participants
- Enrolment
- 3 participants (actual)
- Lead sponsor
- John UckeleUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Posted 17 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy.
Detailed description
Recent advances have shown that certain proteins may be present in a pregnant woman's blood very early in pregnancy which can predict who is at the highest risk for developing preeclampsia. These proteins can be measured and may be used to predict a woman's risk of developing preeclampsia.
Special placental cells called endovascular cytotrophoblasts are needed in the early formation of the placenta. These placental cells invade the maternal blood vessels in the formation of the maternal-placental blood interface. Human Leukocytes Antigen-G (HLA-G) is a protein produced by the placental cells and prevents these special cells from being rejected by the mother's immune system. Recent studies have indicated that the level of HLA-G is decreased in placentas from mothers with preeclampsia. Progesterone, a naturally occurring hormone produced in pregnancy, has been shown to increase the production of HLA-G in the placental cytotrophoblast cells.
In regards to the treatment of preeclampsia, studies have shown that low dose aspirin if given to mothers who have had severe early preeclampsia, lowers the risk for having preeclampsia again. This study aims to show that low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy. Data generated will determine levels and ratios of blood proteins that are predictive of preeclampsia at specific gestational ages.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin plus Placebo Oral Tablet | Placebo comparator | Drug: Aspirin, Drug: Placebo Oral TabletDrug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day |
| Aspirin plus Progesterone | Active comparator | Drug: Aspirin, Drug: ProgesteroneDrug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant patients with a previous history of preeclampsia in the immediate preceding pregnancy.
- 18 to 45 years of age will be included.
Key exclusion criteria (4 listed)
- Patients with chronic hypertension
- children (age < 17 years)
- Patients that are currently taking anti-psychotics or Selective Serotonin Re-uptake Inhibitors
- patients on medications which may be detrimental to the study interpretation will also be excluded at the principal investigator's discretion.
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 |
|---|---|---|
| AspirinAspirin 81 mg once a day | Drug | Aspirin plus Placebo Oral Tablet, Aspirin plus Progesterone |
| Placebo Oral TabletPlacebo 1 tab Daily | Drug | Aspirin plus Placebo Oral Tablet |
| ProgesteroneOral Progesterone 200 mg Twice Daily | Drug | Aspirin plus Progesterone |
Primary outcome
Incidence of Preeclampsia
Time frame: second and third trimester of pregnancy
Number of Participants with preeclampsia in second and third trimester of pregnancy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No study data is available, will not be shared.
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
John E Uckele, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin and Progesterone in people with Preeclampsia, run by John Uckele at 1 site 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 2 inclusion and 4 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 17 Apr 2017. 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 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 17 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Preeclampsia (time frame: second and third trimester of pregnancy). 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 17 Apr 2017.