Pre-EclampsiaNCT03724786
Management of Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection
A study testing Six-hour urine protein collection in people with Pre-Eclampsia, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
In this trial - the investigators plan to study the efficacy of pregnancy management in cases of suspcted preeclampsia, based on a 6-hour urine collection for protein, as compared to the standard 24-hour collection. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Six-hour urine protein collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2019to Jul 2021
- Phase
- Interventional
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients referred to the Edith Wolfson Medical Center for suspected preeclampsia, for whom hospitalization was recommended for urine collection for protein and blood pressure follow up
- Gestational age >24+0 weeks and < 42+0 weeks
- Consent to participation
Who cannot join
- Patients with features of severe preeclampsia at presentation - blood pressure >160/110, headache, blurred vision, right upper quadrant pain, liver transaminase abnormality, increased creatinine level, thrombocytopenia.
- Patients whom were decided to be delivered (regardless of protein collection)
- Multiple gestation
- Chronic hypertension
- Pre-gestational diabetes mellitus
- Thrombophilia (APLA)
- Intrauterine growth retardation
- Lack of prenatal care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Pregnancies With Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection - a Randomized Double Blind Controlled Pilot Study
In this trial - the investigators plan to study the efficacy of pregnancy management in cases of suspcted preeclampsia, based on a 6-hour urine collection for protein, as compared to the standard 24-hour collection. For participants hospitalized at the maternal fetal unit at our institution, one sample of urine collected over 6 hours will be analyzed, and a second one following an additional 18 hours. Participants will be blinded to the urine collection result used to manage their pregnancy (actual 24 hour collection versus calculated 24-hour collection), as will be their attending physicians. An external physician will compare the two urine collection results, and in case only one is pathological (>300 mg), will notify the research team and the attending physician.
- Conditions
- Pre-Eclampsia
- Being tested
- Six-hour urine protein collection
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six-hour urine protein collectionDiagnostic test
This intervention includes the analysis of a 6-hour urine collection for protein, to serve for a calculated 24-hour result, according to which pregnancy will be managed.
| Study group | Role | What they receive |
|---|---|---|
| Calculated collection | Experimental | Patients in this arm will collect urine for protein for 6 hours, and then an additional 18 hours. The result of the 6-hour collection will be multiplied by four, and the result will serve as the "calculated collection", for pregnancy management. The additional 18 hour collection will serve for: 1. Patient blinding. 2. Calculation of the total 24-hour protein collection for reference. Receives: Diagnostic Test: Six-hour urine protein collection |
| Control collection | No intervention | Patients in this arm will collect urine for protein for 6 hours, and then an additional 18 hours. The result of the total 24-hour collection will serve for pregnancy management. The initial 6-hour collection will serve for patient blinding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with an adverse maternal outcome composite
Defined as one of the following maternal complications - hepatic or renal injury, placental abruption, eclampsia, thrombocytopenia, cerebral morbidity, respiratory morbidity, blood pressure > 160/110, need for anti-hypertensives
Measured: Up to 18 weeks
Secondary outcomes (4)
Number of participants whose neonate had an adverse neonatal outcome composite
Defined as one of the following neonatal complications - respiratory distress syndrome, necrotizing enterocolitis, mechanichal ventilation, phototherapy, neonatal intensive care unit admission, sepsis, death
Measured: Up to 18 weeks
Gestational age
Gestational age at delivery
Measured: Single evaluation, up to 18 weeks from recruitment
Number of patients who underwent a cesarean delivery
Delivery by cesarean surgery
Measured: Single evaluation, up to 18 weeks from recruitment
Number of patients who underwent labor induction
Need for labor induction, by mechanichal or pharmaceutical means
Measured: Single evaluation, up to 18 weeks from recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Jan 2019
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hadas Ganer Herman, Wolfson Medical Center
- Investigators
- Hadas Ganer Herman, MD, Principal investigator, Obstetrics and Gynecology, Edith Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724786
- Sponsor's protocol ID
- 0168-18-WOMC
- Status last verified
- Oct 2020
- First submitted
- 29 Oct 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herman HG, Barda G, Miremberg H, Gonen N, Torem M, Kleiner I, Bar J, Weiner E. Management of pregnancies with suspected preeclampsia based on 6-hour vs 24-hour urine protein collection-a randomized double-blind controlled pilot trial. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100429. doi: 10.1016/j.ajogmf.2021.100429. Epub 2021 Jun 25.
PubMed 34182189
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Pregnancies With Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection - a Randomized Double Blind Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03724786
- Acronym / sponsor ID
- 0168-18-WOMC
- Conditions
- Pre-Eclampsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 30 Oct 2018 (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.
In this trial - the investigators plan to study the efficacy of pregnancy management in cases of suspcted preeclampsia, based on a 6-hour urine collection for protein, as compared to the standard 24-hour collection. For participants hospitalized at the maternal fetal unit at our institution, one sample of urine collected over 6 hours will be analyzed, and a second one following an additional 18 hours. Participants will be blinded to the urine collection result used to manage their pregnancy (actual 24 hour collection versus calculated 24-hour collection), as will be their attending physicians. An external physician will compare the two urine collection results, and in case only one is pathological (>300 mg), will notify the research team and the attending physician.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calculated collection | Experimental | Diagnostic Test: Six-hour urine protein collectionPatients in this arm will collect urine for protein for 6 hours, and then an additional 18 hours. The result of the 6-hour collection will be multiplied by four, and the result will serve as the "calculated collection", for pregnancy management. The additional 18 hour collection will serve for: 1. Patient blinding. 2. Calculation of the total 24-hour protein collection for reference. |
| Control collection | No intervention | –Patients in this arm will collect urine for protein for 6 hours, and then an additional 18 hours. The result of the total 24-hour collection will serve for pregnancy management. The initial 6-hour collection will serve for patient blinding. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients referred to the Edith Wolfson Medical Center for suspected preeclampsia, for whom hospitalization was recommended for urine collection for protein and blood pressure follow up
- Gestational age >24+0 weeks and < 42+0 weeks
- Consent to participation
Key exclusion criteria (8 listed)
- Patients with features of severe preeclampsia at presentation - blood pressure >160/110, headache, blurred vision, right upper quadrant pain, liver transaminase abnormality, increased creatinine level, thrombocytopenia.
- Patients whom were decided to be delivered (regardless of protein collection)
- Multiple gestation
- Chronic hypertension
- Pre-gestational diabetes mellitus
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 |
|---|---|---|
| Six-hour urine protein collectionThis intervention includes the analysis of a 6-hour urine collection for protein, to serve for a calculated 24-hour result, according to which pregnancy will be managed. | Diagnostic test | Calculated collection |
Primary outcome
Number of participants with an adverse maternal outcome composite
Time frame: Up to 18 weeks
Defined as one of the following maternal complications - hepatic or renal injury, placental abruption, eclampsia, thrombocytopenia, cerebral morbidity, respiratory morbidity, blood pressure > 160/110, need for anti-hypertensives
4 secondary outcomes
Number of participants whose neonate had an adverse neonatal outcome composite
Time frame: Up to 18 weeks
Gestational age
Time frame: Single evaluation, up to 18 weeks from recruitment
Number of patients who underwent a cesarean delivery
Time frame: Single evaluation, up to 18 weeks from recruitment
Number of patients who underwent labor induction
Time frame: Single evaluation, up to 18 weeks from recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 34182189Herman HG, Barda G, Miremberg H, Gonen N, Torem M, Kleiner I, Bar J, Weiner E. Management of pregnancies with suspected preeclampsia based on 6-hour vs 24-hour urine protein collection-a randomized double-blind controlled pilot trial. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100429. doi: 10.1016/j.ajogmf.2021.100429. Epub 2021 Jun 25.
- 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.
Hadas Ganer Herman, MD principal investigator
Obstetrics and Gynecology, Edith Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Six-hour urine protein collection in people with Pre-Eclampsia, run by Wolfson Medical Center at 1 site in Israel.
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 8 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 Oct 2020. 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 Israel. 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?
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?
Number of participants with an adverse maternal outcome composite (time frame: Up to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03724786, which also lists 1 linked publication.
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 Oct 2020.