Relation Between Protein 13 and Gestational Hypertensive Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Hypertension
• Intervention / Treatment: Diagnostic test: Estimation of Protein 13

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• Egypt
  • El- Qalyobia
    • Banhā, El- Qalyobia, Egypt, 13511
      • Banha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 33 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Non Hypertensive pregnant women

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control	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).
Gestational Hypertension	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).
Pre Eclampsia	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum biomarkers and GHD	The primary outcome is the ability of early ELISA estimation of biomarkers for prediction of GHD	9 months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 12, 2020
• Primary Completion (ACTUAL): March 14, 2021
• Study Completion (ACTUAL): March 19, 2022

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (ACTUAL): August 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: Rc5.6.2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No