Clinical trial NCT05986357: The Relation of High Sensitivity C Reactive Protein and Total Leucocytic Count Levels in Threatened Abortion
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Abortion Early
Keywords: C reactive protein
total and differential leucocytic count
abortion
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Highly sensitive CRP (HS-CRP)
timeFrame: 9 months
measure: total leucocytic count
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
state: Beni Suef
Study officials:
References: