Abortion EarlyNCT05986357
The Relation of High Sensitivity C Reactive Protein and Total Leucocytic Count Levels in Threatened Abortion
An observational study of Abortion Early, run by Beni-Suef University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion Early
- What is being tested?
- maternal serum C reactive protein, total leucocytic count levels and differential leucocytic count levels
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2023to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Age over 40
- smoking
- multiple pregnancies
- endocrinological diseases
- history of repeated spontaneous abortions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
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
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.
- Conditions
- Abortion Early
- Being tested
- maternal serum C reactive protein, total leucocytic count levels, differential leucocytic count levels
- Keywords
- C reactive protein, total and differential leucocytic count, abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maternal serum C reactive proteinDiagnostic test
maternal serum high sensitivity C reactive protein
total leucocytic count levelsDiagnostic test
total leucocytic count levels
differential leucocytic count levelsDiagnostic test
differential leucocytic count levels
| Study group | Role | What they receive |
|---|---|---|
| Study group | 120 healthy women presenting with threatened miscarriage. Receives: 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. Receives: Diagnostic Test: maternal serum C reactive protein; Diagnostic Test: total leucocytic count levels; Diagnostic Test: differential leucocytic count levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highly sensitive CRP (HS-CRP)
A high level of hs-CRP, i.e., greater than 3 mg/L,
Measured: 9 months
total leucocytic count
measures the number of white blood cells (WBCs) in blood
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start30 Jul 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion EarlyStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986357
- Sponsor's protocol ID
- C reactive protein abortion
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05986357
- Acronym / sponsor ID
- C reactive protein abortion
- Conditions
- Abortion Early
- Keywords
- C reactive protein, total and differential leucocytic count, abortion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: maternal serum C reactive protein, Diagnostic Test: total leucocytic count levels, Diagnostic Test: differential leucocytic count levels120 healthy women presenting with threatened miscarriage. |
| Control group | – | Diagnostic Test: maternal serum C reactive protein, Diagnostic Test: total leucocytic count levels, Diagnostic Test: differential leucocytic count levels120 healthy women with an uncomplicated single pregnancy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Age over 40
- smoking
- multiple pregnancies
- endocrinological diseases
- history of repeated spontaneous abortions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maternal serum C reactive proteinmaternal serum high sensitivity C reactive protein | Diagnostic test | Control group, Study group |
| total leucocytic count levelstotal leucocytic count levels | Diagnostic test | Control group, Study group |
| differential leucocytic count levelsdifferential leucocytic count levels | Diagnostic test | Control group, Study group |
Primary outcome
Highly sensitive CRP (HS-CRP)
Time frame: 9 months
A high level of hs-CRP, i.e., greater than 3 mg/L,
total leucocytic count
Time frame: 9 months
measures the number of white blood cells (WBCs) in blood
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Abortion Early
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
RecruitingObservational study
Research on Equity in Abortion Care by TeleHealth
Abortion in First Trimester, Abortion Early
Not yet recruitingPhase 3
Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss
Early Pregnancy Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion Early, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beni-suef University (082 2318605 ext. 02, fom@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highly sensitive CRP (HS-CRP) (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.