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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Six-hour urine protein collection | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 18 weeks |
| Gestational age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadas Ganer Herman, MD | Obstetrics and Gynecology, Edith Wolfson Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edith Wolfson Medical Center | Holon | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34182189 | Derived | 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. |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Gestational age at delivery |
| Single evaluation, up to 18 weeks from recruitment |
| Number of patients who underwent a cesarean delivery | Delivery by cesarean surgery | Single evaluation, up to 18 weeks from recruitment |
| Number of patients who underwent labor induction | Need for labor induction, by mechanichal or pharmaceutical means | Single evaluation, up to 18 weeks from recruitment |