The Relation of High Sensitivity C Reactive Protein and Total Leucocytic Count Levels in Threatened Abortion

The Relation Between Maternal Serum High Sensitivity C Reactive Protein and Total and Differential Leucocytic Count Levels in Healthy Pregnant Women With Threatened Abortion and the Outcome of Pregnancy

to identify the relation between maternal serum high sensitivity C reactive protein and total and differential leucocytic count values in healthy pregnant women with threatened abortion and the outcome of pregnancy

Study Overview

• Status: Not yet recruiting
• Conditions: Abortion Early
• Intervention / Treatment: Diagnostic test: maternal serum C reactive protein; Diagnostic test: total leucocytic count levels; Diagnostic test: differential leucocytic count levels

Detailed Description

observational prospective cohort research will be pregnant women attending to obstetrics and gynecology department of University Hospital. After enrollment, participants will be divided into two groups:

• Study group: had 120 healthy women presenting with threatened miscarriage.
• Control group: had 120 healthy women with an uncomplicated single pregnancy. informed permission will be obtained. All cases subjected to the following: taking complete history, General examination, Special investigations including Obstetric ultrasonography for assessment of gestational age, and exclusion of congenital anomalies or multi-fetal gestation. Laboratory investigations including Estimation of the complete blood picture (CBC), Highly sensitive CRP (HS-CRP) single measurement, Women over 1st trimester abdominal ultrasonographic examination (6-13weeks) using Toshiba with transabdominal transducer probe frequency of 7 MHz to evaluate the following data: Measuring of the fetal crown-rump length (CRL) done to confirm the fetal gestational age and the viability of the fetus. Gestational age will be calculated from the beginning of the last regular menstrual cycle. Women who had hormone therapy or progesterone supplements, as well as pregnancies with a discrepancy between LMP and crown rump length of more than three days, were excluded from the research.

Pregnant women will be under close follow up every 2 weeks by: Obstetric U/S, Measure blood pressure and inform us if severe bleeding occurs.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Beni-suef University; Phone Number: 02 082 2318605; Email: fom@med.bsu.edu.eg

Study Locations

• Egypt
  • Beni Suef
    • Banī Suwayf, Beni Suef, Egypt, 62521
      • Beni-suef university Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Single intrauterine pregnancy with vaginal hemorrhage and/or abdominal pain in the study group, an ultrasound showing an intrauterine gestational sac with a live fetus and a regular fetal heartbeat, with/without a sub-chorionic hematoma, and healthy women who come for routine antenatal care with spontaneous pregnancy.

Description

Inclusion Criteria:

• Single intrauterine pregnancy with vaginal hemorrhage and/or abdominal pain in the study group,
• an ultrasound showing an intrauterine gestational sac with a live fetus and a regular fetal heartbeat, with/without a sub-chorionic hematoma,
• healthy women who come for routine antenatal care with spontaneous pregnancy.

Exclusion Criteria:

• Age over 40
• smoking
• multiple pregnancies
• endocrinological diseases
• history of repeated spontaneous abortions.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; 120 healthy women presenting with threatened miscarriage.	Diagnostic test: maternal serum C reactive protein; maternal serum high sensitivity C reactive protein; Diagnostic test: total leucocytic count levels; total leucocytic count levels; Diagnostic test: differential leucocytic count levels; differential leucocytic count levels
Control group; 120 healthy women with an uncomplicated single pregnancy.	Diagnostic test: maternal serum C reactive protein; maternal serum high sensitivity C reactive protein; Diagnostic test: total leucocytic count levels; total leucocytic count levels; Diagnostic test: differential leucocytic count levels; differential leucocytic count levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highly sensitive CRP (HS-CRP)	A high level of hs-CRP, i.e., greater than 3 mg/L,	9 months
total leucocytic count	measures the number of white blood cells (WBCs) in blood	9 months

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2023
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: abortion; C reactive protein; total and differential leucocytic count
• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Threatened
• Other Study ID Numbers: C reactive protein abortion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No