Clinical trial 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Threatened Miscarriage
Keywords: threatened miscarriage
ultrasound parameters
C reactive protein
first trimester
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of 100 pregnant women, including 50 with threatened miscarriage and 50 healthy controls, recruited from obstetrics clinic at Al-Hussein University Hospital

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum C reactive protein (CRP) levels in threatened miscarriage vs control groups
timeFrame: At enrollment (6-14 weeks gestation)
Secondary outcomes:
measure: Ongoing pregnancy
timeFrame: Ongoing pregnancy assessed at 24 weeks gestation
measure: miscarriage rates
timeFrame: pregnancy loss before 20 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Hussein University Hospital
Study officials:
affiliation: Al-Azhar University
name: Muhamed A Abdelmoaty, M.D.
role: PRINCIPAL_INVESTIGATOR
References: