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

NCT06011057 | Completed DMC

• 1 other identifier: Gyna._531
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Threatened Miscarriage

Keywords

threatened miscarriage; ultrasound parameters; C reactive protein; first trimester

Outcome Measures

Primary Outcomes (1)

• Serum C reactive protein (CRP) levels in threatened miscarriage vs control groups

  Serum C-reactive protein (CRP) levels will be compared between the threatened miscarriage and control groups. CRP levels will be assessed from blood samples collected at the time of enrollment in the study (6-14 weeks gestation). The goal is to determine if CRP levels differ significantly between the threatened miscarriage and control groups and examine the correlation between C reactive protein (CRP) levels and threatened early pregnancy loss.

  At enrollment (6-14 weeks gestation)

Secondary Outcomes (2)

• Ongoing pregnancy

  Ongoing pregnancy assessed at 24 weeks gestation

• miscarriage rates

  pregnancy loss before 20 weeks

Study Arms (2)

threatened miscarriage Group

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.

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

Control Group

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

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

Interventions

Serum C reactive protein (CRP) level DIAGNOSTIC_TEST

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.

Control Group; threatened miscarriage Group

Ultrasound DIAGNOSTIC_TEST

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).

Control Group; threatened miscarriage Group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: This study will only enroll pregnant women whose gender identity and biological sex assigned at birth are both female. Individuals who identify as any gender other than female will not be eligible, as the study is specifically assessing threatened miscarriage and pregnancy outcomes in women based on their biological sex. Eligible participants must self-identify and be biologically classified as female to align with the research questions on CRP levels, ultrasound findings, and pregnancy loss risk in women with threatened first trimester miscarriage.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Hussein University Hospital

Cairo, 11633, Egypt

Location

MeSH Terms

Conditions

Abortion, Threatened

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Muhamed A Abdelmoaty, M.D.

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer and consultant at Obstetrics and Gynecology Department.

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: July 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)