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NCT05517512 Clinical Trial

Relation Between Protein 13 and Gestational Hypertensive Disorder

Gestational Hypertension Clinical Trial

Official title:
Low Serum Pregnancy Protein 13 Early in Pregnancy Might Predict the Oncoming Gestational Hypertensive Disorders, Especially Early-onset Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05517512
Other study ID # Rc5.6.2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 12, 2020
Est. completion date March 19, 2022

Study information
Verified date August 2022
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

the attendants of the clinic with a one-missed period (T0) underwent determination of baseline blood pressure (BP) measures and gave blood samples for estimation of levels of placental growth factor (PLGF), soluble fms-like tyrosine kinase-1 (sFlt-1) and pregnancy protein 13 (PP13). The same evaluation was repeated on the 6th, 24th, 32nd, and 36th gestational week (GW). Twenty non-pregnant women gave samples as a negative control group.

Recruitment information / eligibility
Status Completed
Enrollment 138
Est. completion date March 19, 2022
Est. primary completion date March 14, 2021
Accepts healthy volunteers
Gender Female
Age group 21 Years to 33 Years
Eligibility Inclusion Criteria: - Normotensive women who attended the clinic with a one-missed period (T0) Exclusion Criteria: - History of essential hypertension (HTN) - renal diseases - hepatic diseases - cardiac diseases - metabolic syndrome - body mass index (BMI) >35 kg/ m2 - congenital heart diseases

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Estimation of Protein 13
Serum biomarkers' levels were measured using enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions and were read using a 96 well microplate ELISA reader (Dynatech. MR 7000) Human placental growth factor (PLGF) was measured with the enzyme-linked immunoassay (ELISA) kit (catalog no. DPG00 SPG00 PDPG00, R&D Systems Inc., Minneapolis, USA) by quantitative sandwich enzyme immunoassay technique (20). Human soluble fms-like tyrosine kinase-1 (sFlt-1) was measured with the enzyme-linked immunoassay (ELISA) kit (catalog no. MBS601616, MyBioSource, Inc., California, San Diego, USA) by quantitative sandwich enzyme immunoassay technique (21). Human pregnancy protein 13 was measured with the enzyme-linked immunoassay (ELISA) kit (catalog no. ab100553, Abcam Inc., Cambridge, USA) by quantitative sandwich enzyme immunoassay technique (22).

Locations
Country Name City State
Egypt Banha University Banha El- Qalyobia

Sponsors (1)
Lead Sponsor Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum biomarkers and GHD The primary outcome is the ability of early ELISA estimation of biomarkers for prediction of GHD 9 months
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