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

NCT ID: NCT05986357

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-30

Study Completion Date

2023-10-30

Brief Summary

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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

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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.

Conditions

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Abortion Early

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

120 healthy women presenting with threatened miscarriage.

maternal serum C reactive protein

Intervention Type DIAGNOSTIC_TEST

maternal serum high sensitivity C reactive protein

total leucocytic count levels

Intervention Type DIAGNOSTIC_TEST

total leucocytic count levels

differential leucocytic count levels

Intervention Type DIAGNOSTIC_TEST

differential leucocytic count levels

Control group

120 healthy women with an uncomplicated single pregnancy.

maternal serum C reactive protein

Intervention Type DIAGNOSTIC_TEST

maternal serum high sensitivity C reactive protein

total leucocytic count levels

Intervention Type DIAGNOSTIC_TEST

total leucocytic count levels

differential leucocytic count levels

Intervention Type DIAGNOSTIC_TEST

differential leucocytic count levels

Interventions

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maternal serum C reactive protein

maternal serum high sensitivity C reactive protein

Intervention Type DIAGNOSTIC_TEST

total leucocytic count levels

total leucocytic count levels

Intervention Type DIAGNOSTIC_TEST

differential leucocytic count levels

differential leucocytic count levels

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Sara Abdallah Mohamed Salem

principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Beni-suef University

Role: CONTACT

082 2318605 ext. 02

Other Identifiers

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C reactive protein abortion

Identifier Type: -

Identifier Source: org_study_id

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