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
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Gestational Hypertension
• Hypertension
• Hypertension, Pregnancy-Induced

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