Gestational HypertensionNCT05517512
Relation Between Protein 13 and Gestational Hypertensive Disorder
An observational study of Gestational Hypertension, run by Benha University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 21 to 33 years, women only
- Conditions the study is for
- Gestational Hypertension
- What is being tested?
- Estimation of Protein 13
- How many people
- 138 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2020to 19 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 33 years
- Women only
- Adult
Study population: Non Hypertensive pregnant women
Who may be able to join
- Normotensive women who attended the clinic with a one-missed period (T0)
Who cannot join
- History of essential hypertension (HTN)
- renal diseases
- hepatic diseases
- cardiac diseases
- metabolic syndrome
- body mass index (BMI) >35 kg/ m2
- congenital heart diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Gestational Hypertension
- Being tested
- Estimation of Protein 13
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estimation of Protein 13Diagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| Gestational Hypertension | Not described Receives: Diagnostic Test: Estimation of Protein 13 | |
| Pre Eclampsia | Not described Receives: Diagnostic Test: Estimation of Protein 13 | |
| Control | Not described Receives: Diagnostic Test: Estimation of Protein 13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum biomarkers and GHD
The primary outcome is the ability of early ELISA estimation of biomarkers for prediction of GHD
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start12 Mar 2020
- Primary completion14 Mar 2021
- Study completion19 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Sharaf Eldein, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517512
- Sponsor's protocol ID
- Rc5.6.2022
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Serum Pregnancy Protein 13 Early in Pregnancy Might Predict the Oncoming Gestational Hypertensive Disorders, Especially Early-onset Preeclampsia
- ClinicalTrials.gov ID
- NCT05517512
- Acronym / sponsor ID
- Rc5.6.2022
- Conditions
- Gestational Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 14 Mar 2021 (actual)
- Study completion
- 19 Mar 2022 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gestational Hypertension | – | Diagnostic Test: Estimation of Protein 13 |
| Pre Eclampsia | – | Diagnostic Test: Estimation of Protein 13 |
| Control | – | Diagnostic Test: Estimation of Protein 13 |
Who may qualify
- Ages
- 21 to 33 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Non Hypertensive pregnant women
Key inclusion criteria (1 listed)
- Normotensive women who attended the clinic with a one-missed period (T0)
Key exclusion criteria (7 listed)
- History of essential hypertension (HTN)
- renal diseases
- hepatic diseases
- cardiac diseases
- metabolic syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estimation of Protein 13Serum 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). | Diagnostic test | Control, Gestational Hypertension, Pre Eclampsia |
Primary outcome
Serum biomarkers and GHD
Time frame: 9 months
The primary outcome is the ability of early ELISA estimation of biomarkers for prediction of GHD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Hypertension, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum biomarkers and GHD (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.