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

Not yet recruiting
Conditions
Abortion Early
Interventions
Diagnostic Test: maternal serum C reactive protein
Diagnostic Test: total leucocytic count levels
Diagnostic Test: differential leucocytic count levels
Registration Number
NCT05986357
Lead Sponsor
Beni-Suef University
Brief Summary

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

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
240
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Study groupmaternal serum C reactive protein120 healthy women presenting with threatened miscarriage.
Study grouptotal leucocytic count levels120 healthy women presenting with threatened miscarriage.
Control groupmaternal serum C reactive protein120 healthy women with an uncomplicated single pregnancy.
Control grouptotal leucocytic count levels120 healthy women with an uncomplicated single pregnancy.
Study groupdifferential leucocytic count levels120 healthy women presenting with threatened miscarriage.
Control groupdifferential leucocytic count levels120 healthy women with an uncomplicated single pregnancy.
Primary Outcome Measures
NameTimeMethod
Highly sensitive CRP (HS-CRP)9 months

A high level of hs-CRP, i.e., greater than 3 mg/L,

total leucocytic count9 months

measures the number of white blood cells (WBCs) in blood

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Beni-suef university Hospital

🇪🇬

Banī Suwayf, Beni Suef, Egypt

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