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

Al-Azhar University

Status: Completed

Conditions: Threatened Miscarriage

Treatments: Diagnostic Test: Serum C reactive protein (CRP) level; Diagnostic Test: Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT06011057

Gyna._531

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All pregnant women in the age group (20-35) between 7 and 13 weeks gestation in which a singleton embryo with evident cardiac activity with sure last menstrual period (LMP) constant with 1st trimester documented ultrasound

• The included subjects will be divided into two groups:-

  1. Group 1 (control) will consist of 50 pregnant women with uneventful pregnancies without any problem.
  2. Group 2 (patients) will consist of 50 pregnant women with threatened miscarriage, of them.

Exclusion criteria

• Multiple pregnancies.
• Women having received hormonal treatment or progesterone supplements.
• Pregnancies with a difference of more than 7 days between last menstrual period (LMP) and crown- rump length.
• History of general medical disease e.g. diabetes, thyroid disease or antiphospholipid syndrome, Presence of local (gynecological) disease e.g. fibroid or adnexal masses verified by normal appearance of the uterus and ovaries by ultrasound.
• Presence of uterine malformations e.g. hypoplastic uterus or septate uterus diagnosed by history of recurrent miscarriage, hysterosalpingography or 3D ultrasound, Intake of natural or synthetic progesterone.
• Obesity.
• Ectopic pregnancy
• Vesicular mole
• Fetal demise by Ultrasound

Trial design

100 participants in 2 patient groups

threatened miscarriage Group

Description:

This group will include 50 pregnant women presenting with vaginal bleeding and/or abdominal cramps concerning for possible miscarriage in the first trimester. Inclusion criteria will be gestational age between 6-14 weeks by last menstrual period and/or ultrasound dating, and clinical signs/symptoms suggestive of threatened miscarriage including: Vaginal bleeding Abdominal cramps/pain Closed cervical os on exam Women with confirmed fetal demise on ultrasound will be excluded. Participants in this group will undergo blood testing to measure C reactive protein (CRP) level and fetal ultrasound to assess parameters like crown-rump length, heartbeat, yolk sac size, and embryonic motion. This group will provide data to assess C reactive protein (CRP) and ultrasound findings in women with threatened first trimester miscarriage.

Treatment:

Diagnostic Test: Ultrasound

Diagnostic Test: Serum C reactive protein (CRP) level

Control Group

Description:

The control group will include 50 low-risk pregnant women matched to the threatened miscarriage group based on gestational age. Inclusion criteria are normal pregnancy dating, no vaginal bleeding/cramping, normal prior ultrasounds, and no history of pregnancy complications. Controls will undergo the same CRP blood testing and fetal ultrasounds as the threatened miscarriage group. This will provide comparative normal pregnancy CRP and ultrasound data. Matching controls on demographics and gestation will allow analysis of differences in CRP and ultrasound parameters between groups to determine predictors of pregnancy viability. Copy Retry

Treatment:

Diagnostic Test: Ultrasound

Diagnostic Test: Serum C reactive protein (CRP) level