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

Abortion Early Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05986357
• Other study ID #: C reactive protein abortion
• Status: Not yet recruiting
• Start date: July 30, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: August 2023
• Source: Beni-Suef University
• Contact: Beni-suef University
• Phone: 082 2318605
• Email: fom[@]med.bsu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion Early
• Abortion, Threatened

Intervention

Diagnostic Test:
• maternal serum C reactive protein
maternal serum high sensitivity C reactive protein
• total leucocytic count levels
total leucocytic count levels
• differential leucocytic count levels
differential leucocytic count levels

Locations

Country	Name	City	State
Egypt	Beni-suef university Hospital	Bani Suwayf	Beni Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

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