NCT06011057

Evaluation of Serum Levels of C Reactive Protein (CRP) and Its Correlation With Fetal Ultrasound Parameters in the Prediction of Threatened Miscarriage in the First Trimester

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The goal of this observational study is to evaluate and compare in pregnant women with threatened miscarriage in the first trimester. The main questions it aims to answer are: What is the correlation between serum C reactive protein (CRP) levels and fetal ultrasound parameters in predicting threatened miscarriage? How accurate are serum C reactive protein (CRP) levels versus ultrasound in predicting pregnancy loss in threatened miscarriage? Participants will have blood tests to measure C reactive protein (CRP) levels and fetal ultrasound exams to assess parameters like crown-rump length. Researchers will compare serum C reactive protein (CRP) levels and fetal ultrasound findings to see if either or both can accurately predict pregnancy loss in women with first trimester threatened miscarriage.

Detailed description

This observational study will enroll 100 pregnant women, with 50 in the threatened miscarriage group and 50 healthy controls, to compare serum C reactive protein (CRP) levels and fetal ultrasound findings for predicting early pregnancy loss. Women presenting with first trimester bleeding and cramps concerning for threatened miscarriage will undergo blood testing to measure C reactive protein (CRP) levels and fetal ultrasound to assess parameters including crown-rump length, heartbeat, yolk sac size, and embryonic motion. The control group will consist of 50 low-risk pregnant women without threatened miscarriage matched for gestational age. Controls will undergo the same blood and ultrasound assessments. Researchers will compare serum C reactive protein (CRP) levels and ultrasound measurements between the threatened miscarriage and control groups. They will analyze which parameters differ significantly between groups and examine the predictive utility of C reactive protein (CRP) levels versus ultrasound for determining pregnancy viability. Key outcomes will include correlation of C reactive protein (CRP) with ultrasound parameters, and diagnostic accuracy of C reactive protein (CRP) levels versus ultrasound in predicting pregnancy loss in threatened first trimester miscarriages. This study aims to help optimize early pregnancy loss prediction and counseling for women with potential threatened miscarriage.

Conditions

• Threatened Miscarriage

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Serum C reactive protein (CRP) level	An immunoturbidimetric method using a Modular P Analyzer will be used to carry out HSCRP assay, with a quantitation limit of 0.5 mg/L.
DIAGNOSTIC_TEST	Ultrasound	All examinations will be carried out by an experience operator with a transvaginal probe on high-resolution ultrasound machines. Pregnancies will be dated from the LMP. Other measurements will be obtained during the scan as the mean gestation sac diameter, volume of the gestation sac and the embryonic heart rate (FHR).

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2023-08-25
• Last updated: 2023-12-12

Locations

1 site across 1 country: Egypt