Preterm PreeclampsiaPhase 2/3SILNCT02782559
Efficacy of Sildenafil in Preterm Preeclampsia
A Phase 2/3 study testing Sildenafil in people with Preterm Preeclampsia, run by The University of Texas Health Science Center, Houston.
Trial summary
Randomized controlled trial to assess efficacy of Sildenafil in addition to expectant management for the treatment of preterm preeclampsia Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preterm Preeclampsia
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- Phase
- Phase 2/3
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hospitalized patients of gestational age of ≥24 0/7 weeks to ≤32 0/7 weeks.
- Dating of pregnancy by ultrasound < or equal to 22 weeks or IVF conception
- Diagnosis of Preterm Preeclampsia or Superimposed Preeclampsia
Who cannot join
- Need for immediate delivery of the fetus
- Known lethal anomaly
- Pre-existing renal disease
- Hypersensitivity to sildenafil
- Pre-gestational diabetes, class C (onset prior to 10-19 or duration 10-19 yrs
- Active peptic ulcer disease
- Undergoing nitrate therapy
About this study
Official title: Randomized Double-Blind, Placebo Controlled Evaluation of the Efficacy of Sildenafil Versus Placebo in Preterm Preeclampsia
Randomized controlled trial to assess efficacy of Sildenafil in addition to expectant management for the treatment of preterm preeclampsia
Read the detailed description
Preeclampsia is a major cause of maternal mortality. When preeclampsia presents prior to thirty-four weeks of gestation, expectant management is the standard practice in stable patients with the goal of extending pregnancy and therefore decreasing the risk of adverse outcomes in the premature neonate. Our aim was to assess the efficacy of Sildenafil, a phosphodiesterase inhibitor, versus placebo, in addition to expectant management, for the treatment of preterm preeclampsia to prolong pregnancy.
- Conditions
- Preterm Preeclampsia
- Being tested
- Sildenafil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
PlaceboDrug
Color and size matched to active drug (sildenafil)
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | Sildenafil 40mg oral tablet three times a day from randomization until delivery Receives: Drug: Sildenafil |
| Placebo | Placebo comparator | Matched to oral capsule of active treatment three times a day from randomization until delivery Receives: Drug: Sildenafil; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency (duration of pregnancy from diagnosis/randomization until delivery)
earliest randomization can occur at 24 weeks gestation
Measured: Diagnosis (randomization) until delivery, up to 34 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJul 2016 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Why it stopped: difficulties acquiring the drug and funding for the drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm PreeclampsiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robyn P Roberts, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782559
- Sponsor's protocol ID
- HSC-MS-16-0083
- Acronym
- SIL
- Status last verified
- Mar 2018
- First submitted
- 11 Feb 2016
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind, Placebo Controlled Evaluation of the Efficacy of Sildenafil Versus Placebo in Preterm Preeclampsia
- ClinicalTrials.gov ID
- NCT02782559
- Acronym / sponsor ID
- SIL / HSC-MS-16-0083
- Conditions
- Preterm Preeclampsia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulties acquiring the drug and funding for the drug
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jul 2016 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 25 May 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.
Randomized controlled trial to assess efficacy of Sildenafil in addition to expectant management for the treatment of preterm preeclampsia
Detailed description
Preeclampsia is a major cause of maternal mortality. When preeclampsia presents prior to thirty-four weeks of gestation, expectant management is the standard practice in stable patients with the goal of extending pregnancy and therefore decreasing the risk of adverse outcomes in the premature neonate. Our aim was to assess the efficacy of Sildenafil, a phosphodiesterase inhibitor, versus placebo, in addition to expectant management, for the treatment of preterm preeclampsia to prolong pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: SildenafilSildenafil 40mg oral tablet three times a day from randomization until delivery |
| Placebo | Placebo comparator | Drug: Sildenafil, Drug: PlaceboMatched to oral capsule of active treatment three times a day from randomization until delivery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hospitalized patients of gestational age of ≥24 0/7 weeks to ≤32 0/7 weeks.
- Dating of pregnancy by ultrasound < or equal to 22 weeks or IVF conception
- Diagnosis of Preterm Preeclampsia or Superimposed Preeclampsia
Key exclusion criteria (7 listed)
- Need for immediate delivery of the fetus
- Known lethal anomaly
- Pre-existing renal disease
- Hypersensitivity to sildenafil
- Pre-gestational diabetes, class C (onset prior to 10-19 or duration 10-19 yrs
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 |
|---|---|---|
| Sildenafil | Drug | Placebo, Sildenafil |
| PlaceboColor and size matched to active drug (sildenafil) | Drug | Placebo |
Primary outcome
Latency (duration of pregnancy from diagnosis/randomization until delivery)
Time frame: Diagnosis (randomization) until delivery, up to 34 weeks)
earliest randomization can occur at 24 weeks gestation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Individual participant dataSharing planned: Yes
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Blood Pressure Goal in Preterm Preeclampsia
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Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study
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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.
Robyn P Roberts, MD principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sildenafil in people with Preterm Preeclampsia, run by The University of Texas Health Science Center, Houston.
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 7 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: withdrawn, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Latency (duration of pregnancy from diagnosis/randomization until delivery) (time frame: Diagnosis (randomization) until delivery, up to 34 weeks)). 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 27 Mar 2018.