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

Sponsor
Beni-Suef University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05986357
Collaborator
(none)
240
1
3
79.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
240 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Jul 30, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Highly sensitive CRP (HS-CRP) [9 months]

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

  2. total leucocytic count [9 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beni-suef university Hospital Banī Suwayf Beni Suef Egypt 62521

Sponsors and Collaborators

  • Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sara Abdallah Mohamed Salem, principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University
ClinicalTrials.gov Identifier:
NCT05986357
Other Study ID Numbers:
  • C reactive protein abortion
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sara Abdallah Mohamed Salem, principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023