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
1 other identifier
observational
138
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2022
CompletedFirst Submitted
Initial submission to the registry
August 9, 2022
CompletedFirst Posted
Study publicly available on registry
August 26, 2022
CompletedAugust 26, 2022
August 1, 2022
1 year
August 9, 2022
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Serum biomarkers and GHD
The primary outcome is the ability of early ELISA estimation of biomarkers for prediction of GHD
9 months
Study Arms (3)
Gestational Hypertension
Pre Eclampsia
Control
Interventions
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) 1. 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). 2. 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). 3. 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).
Eligibility Criteria
Non Hypertensive pregnant women
You may qualify if:
- Normotensive women who attended the clinic with a one-missed period (T0)
You may not qualify if:
- History of essential hypertension (HTN)
- renal diseases
- hepatic diseases
- cardiac diseases
- metabolic syndrome
- body mass index (BMI) \>35 kg/ m2
- congenital heart diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Banha University
Banhā, El- Qalyobia, 13511, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of gynecology
Study Record Dates
First Submitted
August 9, 2022
First Posted
August 26, 2022
Study Start
March 12, 2020
Primary Completion
March 14, 2021
Study Completion
March 19, 2022
Last Updated
August 26, 2022
Record last verified: 2022-08