Relation Between Protein 13 and Gestational Hypertensive Disorder
August 24, 2022 updated by: Amr Sharaf Eldein, Benha University
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
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
138
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
El- Qalyobia
-
Banhā, El- Qalyobia, Egypt, 13511
- Banha University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control
|
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)
|
|
Gestational Hypertension
|
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)
|
|
Pre Eclampsia
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum biomarkers and GHD
Time Frame: 9 months
|
The primary outcome is the ability of early ELISA estimation of biomarkers for prediction of GHD
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.