NCT05986357

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

July 25, 2023

Last Update Submit

August 1, 2023

Conditions

Keywords

C reactive proteintotal and differential leucocytic countabortion

Outcome Measures

Primary Outcomes (2)

  • Highly sensitive CRP (HS-CRP)

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

    9 months

  • total leucocytic count

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

    9 months

Study Arms (2)

Study group

120 healthy women presenting with threatened miscarriage.

Diagnostic Test: maternal serum C reactive proteinDiagnostic Test: total leucocytic count levelsDiagnostic Test: differential leucocytic count levels

Control group

120 healthy women with an uncomplicated single pregnancy.

Diagnostic Test: maternal serum C reactive proteinDiagnostic Test: total leucocytic count levelsDiagnostic Test: differential leucocytic count levels

Interventions

maternal serum high sensitivity C reactive protein

Control groupStudy group

total leucocytic count levels

Control groupStudy group

differential leucocytic count levels

Control groupStudy group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

Central Study Contacts

Beni-suef University

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 14, 2023

Study Start

July 30, 2023

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations