NCT06214702

Brief Summary

Evaluation of the predictability of estimated levels of Serpin C, sFlt-1 and placental growth factor (PLGF) in blood samples obtained during the 1st trimester from normotensive pregnant women for identification of women liable to develop PE during the course of pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 10, 2024

Last Update Submit

January 18, 2024

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

  • Role of Biomarkers in detection of GHTN

    The predictability of serum biomarkers' levels estimated at enrolment for the development of GHTN.

    9 months

Study Arms (2)

Study group

Patients with diastolic blood pressure (DBP) after the 20th GW up ≥140 or 90 mmHg without proteinuria.

Diagnostic Test: ELISA

Control Group

Patients were normotensive at the 20th GW.

Diagnostic Test: ELISA

Interventions

ELISADIAGNOSTIC_TEST

ELISA estimation of PLGF, sFlt-1 and Serpin C

Control GroupStudy group

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients were having monthly follow-up of pregnancy and determination of BP measures, and estimation of the serum levels of the studied biomarkers. Patients who developed GHTN at the 20th GW were grouped as GHTN group and those who were normotensive at the 20th GW were considered as control.

You may qualify if:

  • Normotensive pregnant women had singleton fetus presenting during the 1st trimester

You may not qualify if:

  • Age
  • Sex
  • Hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banha University

Banhā, El- Qalyobia, 13511, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 22, 2024

Study Start

January 7, 2023

Primary Completion

May 12, 2023

Study Completion

November 15, 2023

Last Updated

January 22, 2024

Record last verified: 2024-01

Locations

EG(1)