PreeclampsiaPhase 3NCT01890005
Low Dose Aspirin for the Prevention of Preeclampsia
A Phase 3 study testing Aspirin in people with Preeclampsia, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 476 participants
- Where
- 1 sitePanama
- Study dates
- Jul 2013to Jan 2014
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age between 13 and 16 weeks of pregnancy
- High risk of preeclampsia, based in clinical risk factors as:
- Preeclampsia in a previous pregnancy Mother or sister that developed preeclampsia in a previous pregnancy Diabetes Mellitus (insulin dependant) Chronic Hypertension (with/without proteinuria) Body Mass Index > 32 Multiple pregnancy Lupus or other autoimmune disorder Chronic Renal Disease.
Who cannot join
- Blood coagulation disorders of any kind
- Peptic ulcers
- Allergy to aspirin
- Chronic use of anti-inflammatory drugs
- Fetus with mayor anomalies
Trial locations and contacts
1 site in 1 country.
Rodrigo Velarde, MD contact
Osvaldo Reyes, MD contact
Panama1 site
Saint Thomas Maternity Hospital
Panama City
Rodrigo Velarde, MD, revelarde_14@yahoo.es
Osvaldo Reyes, MD, oreyespanama@yahoo.es
About this study
Official title: Low Dose Aspirin Between 13 and 16 Weeks of Pregnancy for the Prevention of Preeclampsia. Double Blind, Randomized, Controlled Trial.
Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. The investigators decided to evaluate the use of low dose aspirin, starting between 13 and 16 weeks of pregnancy, based on clinical characteristics only to reduce the incidence of preeclampsia.
- Conditions
- Preeclampsia
- Being tested
- Aspirin, Placebo
- Keywords
- Preeclampsia, Low dose aspirin, Fetal growth restriction, Neonatal death, Stillbirth, Abruptio placenta
- Medical subject headings
- Pre-Eclampsia, Fetal Growth Retardation, Perinatal Death, Stillbirth, Abruptio Placentae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
PlaceboDrug
Placebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night. Receives: Drug: Aspirin |
| Placebo | Placebo comparator | Placebo (identical to low dose aspirin (100 mg)) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of preeclampsia
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy
Measured: 6 months
Secondary outcomes (6)
Prevention of preeclampsia at term
The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
Measured: 6 months
Stillbirth
The number of cases of stillbirths that appear in both groups at any given time during pregnancy.
Measured: 6 months
Neonatal deaths
The number of cases of neonatal deaths that appear in both groups, regardless of the cause.
Measured: 6 months
Neonatal intensive care unit admissions.
The number of cases that require admittance to the Neonatal Intensive Care Unit in both groups in the first 28 days after birth.
Measured: 28 days
Abruptio placenta
The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.
Measured: 6 months
Fetal Growth Restriction
The number of cases of fetal growth restriction, defined as a fetal weight below the 10th percentile and an abnormal umbilical cord doppler that appear in both groups at any given time during pregnancy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo Reyes, MD, Principal investigator, Saint Thomas Maternity HospitalRodrigo Velardee, MD, Principal investigator, Saint Thomas Maternity HospitalAmeth Hawkins, MD, Principal investigator, Saint Thomas Maternity HospitalAna Moreno, MD, Principal investigator, Saint Thomas Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890005
- Sponsor's protocol ID
- MHST2013-05
- Status last verified
- Jun 2013
- First submitted
- 26 Jun 2013
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Aspirin Between 13 and 16 Weeks of Pregnancy for the Prevention of Preeclampsia. Double Blind, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01890005
- Acronym / sponsor ID
- MHST2013-05
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Low dose aspirin, Fetal growth restriction, Neonatal death, Stillbirth, Abruptio placenta
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 1 Jul 2013 (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.
Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. The investigators decided to evaluate the use of low dose aspirin, starting between 13 and 16 weeks of pregnancy, based on clinical characteristics only to reduce the incidence of preeclampsia.
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 | Experimental | Drug: AspirinLow dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (identical to low dose aspirin (100 mg)) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age between 13 and 16 weeks of pregnancy
- High risk of preeclampsia, based in clinical risk factors as:
- Preeclampsia in a previous pregnancy Mother or sister that developed preeclampsia in a previous pregnancy Diabetes Mellitus (insulin dependant) Chronic Hypertension (with/without proteinuria) Body Mass Index > 32 Multiple pregnancy Lupus or other autoimmune disorder Chronic Renal Disease.
Key exclusion criteria (5 listed)
- Blood coagulation disorders of any kind
- Peptic ulcers
- Allergy to aspirin
- Chronic use of anti-inflammatory drugs
- Fetus with mayor anomalies
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 |
|---|---|---|
| AspirinLow dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night. | Drug | Aspirin |
| PlaceboPlacebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night. | Drug | Placebo |
Primary outcome
Prevention of preeclampsia
Time frame: 6 months
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy
6 secondary outcomes
Prevention of preeclampsia at term
Time frame: 6 months
Stillbirth
Time frame: 6 months
Neonatal deaths
Time frame: 6 months
Neonatal intensive care unit admissions.
Time frame: 28 days
Abruptio placenta
Time frame: 6 months
Fetal Growth Restriction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
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Preeclampsia (PE)
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.
Rodrigo Velarde, MD contact
Osvaldo Reyes, MD contact
Osvaldo Reyes, MD principal investigator
Saint Thomas Maternity Hospital
Rodrigo Velardee, MD principal investigator
Saint Thomas Maternity Hospital
Ameth Hawkins, MD principal investigator
Saint Thomas Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin in people with Preeclampsia, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 3 inclusion and 5 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 1 Jul 2013. 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 Panama. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rodrigo Velarde, MD (revelarde_14@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of preeclampsia (time frame: 6 months). 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 1 Jul 2013; AzTrials last refreshed its copy on 8 Nov 2026.