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Not yet recruitingNCT05986357Updated Aug 14, 2023

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

An observational study in Abortion Early, sponsored by Beni-Suef University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Beni-Suef University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2023, 2 years 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
240
Ages
18 Years to 40 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Abortion Early

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Keywords

  • C reactive protein
  • total and differential leucocytic count
  • abortion
03

In context

Abortion, Threatened

22 studies on the registry are indexed under Abortion, Threatened; 2 are open to participants now.

This study's planned enrollment of 240 is above the median of 150 across 11 observational studies indexed under Abortion, Threatened.

Browse Abortion, Threatened studies →

Lead sponsor

Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
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.

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

Exclusion Criteria:

  • Age over 40
  • smoking
  • multiple pregnancies
  • endocrinological diseases
  • history of repeated spontaneous abortions.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
240 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study group

    120 healthy women presenting with threatened miscarriage.

    Diagnostic Test: maternal serum C reactive protein · Diagnostic Test: total leucocytic count levels · Diagnostic Test: differential leucocytic count levels

  • Control group

    120 healthy women with an uncomplicated single pregnancy.

    Diagnostic Test: maternal serum C reactive protein · Diagnostic Test: total leucocytic count levels · Diagnostic Test: differential leucocytic count levels

Interventions

  • Diagnostic testmaternal serum C reactive protein

    maternal serum high sensitivity C reactive protein

  • Diagnostic testtotal leucocytic count levels

    total leucocytic count levels

  • Diagnostic testdifferential leucocytic count levels

    differential leucocytic count levels

06

What researchers measure

Primary outcomes

  1. Highly sensitive CRP (HS-CRP)

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

    Time frame: 9 months

  2. total leucocytic count

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

    Time frame: 9 months

07

Study locations

1 site
  • Beni-suef university Hospital
    Banī Suwayf, Beni Suef 62521, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05986357
Lead sponsor
Beni-Suef University
Responsible party
Sara Abdallah Mohamed Salem (principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University) — Principal investigator
First posted
Aug 14, 2023
Start date
Jul 30, 2023 (estimated)
Primary completion
Oct 30, 2023 (estimated)
Completion
Oct 30, 2023 (estimated)
Last update
Aug 14, 2023

Study contacts

Beni-suef University
Contact
fom@med.bsu.edu.eg
082 2318605 ext. 02

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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