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Clinical Trials/NCT06685549
NCT06685549CompletedNot Applicable

The Relationship Between Isolated Head Trauma During Pregnancy and Preterm Birth

Sanliurfa Education and Research Hospital1 site in 1 country90 target enrollmentStarted: January 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
results of isolated head trauma

Study Overview

Brief Summary

Pregnant patients who presented to the Emergency Department of Şanlıurfa Training and Research Hospital with isolated head trauma due between January 2018 and January 2024 were included in the study and followed up with until the time of pregnancy termination.

Detailed Description

The criteria for inclusion in the study were as follows: all of the pregnant women over 18 years of age with isolated head trauma (closed blunt trauma) who were evaluated with neurosurgical consultation or computed tomography/magnetic resonance (CT/MRI) and whose birth records are available at our hospital.

The exclusion criteria included patients with previous premature birth, pregnancies in the first trimester, pregnancies with assisted reproductive techniques, multiple pregnancy, the threat of preterm labor or abortus imminens in the current pregnancy, maternal or fetal life-threatening situations that may cause termination of the pregnancy, cervical insufficiency, short cervix or history of conization, asymptomatic bacteriuria, periodontal disease, and smoking and substance use. Patients who had trauma to the other parts of the body or placental abruption were also excluded. Additionally, the study did not include those with missing hospital records regarding birth and pregnancy follow-up.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •All of the pregnant women over 18 years of age with isolated head trauma (closed blunt trauma) who were evaluated with neurosurgical consultation or computed tomography/magnetic resonance (CT/MRI) and whose birth records are available at our hospital.

Exclusion Criteria

  • •Patients with previous premature birth, Pregnancies in the first trimester, Pregnancies with assisted reproductive techniques, Multiple pregnancy, The threat of preterm labor or abortus imminens in the current pregnancy, Maternal or fetal life-threatening situations that may cause termination of the pregnancy, Cervical insufficiency, Short cervix or history of conization, Diagnosis of asymptomatic bacteriuria, Diagnosis of periodontal disease, Smoking and substance use. Patients who had trauma to the other parts of the body or placental abruption Missing hospital records regarding birth and pregnancy follow-up.

Outcomes

Primary Outcomes

results of isolated head trauma

Time Frame: following maximum time for 6 months, until each pregnant's birth

CT/MRI result of the patients' head trauma, whether they had surgery on the brain after the trauma, ward or intensive care hospitalizations

birth results

Time Frame: following maximum time for 6 months, until each pregnant's birth

gestational week at birth

preterm birth results

Time Frame: following maximum time for 6 months, until each pregnant's birth

whether preterm birth occurs, the baby's delivery method and weight

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sanliurfa Education and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Alev Esercan

Dr.

Sanliurfa Education and Research Hospital

Study Sites (1)

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