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Completed

NCT Number: NCT05517512

Relation Between Protein 13 and Gestational Hypertensive Disorder

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.

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Key information

Conditions

Gestational Hypertension Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

21 year–33 year

Sex eligibility

Female

Study type

Observational

Primary location

Banha University

Banhā, El- Qalyobia, 13511, Egypt

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estimation of Protein 13

Diagnostic Test

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).

Primary outcomes

  1. Serum biomarkers and GHD

    Time frame: 9 months

    The primary outcome is the ability of early ELISA estimation of biomarkers for prediction of GHD

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 26, 2022
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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