Clinical trial NCT06685549: The Relationship Between Isolated Head Trauma During Pregnancy and Preterm Birth
Official title: The Relationship Between Isolated Head Trauma During Pregnancy and Preterm Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superficial Injuries Involving Head With Neck
Keywords: cervical dilatation
head trauma
preterm birth
placental abruption
vaginal bleeding
Lead sponsor: Sanliurfa Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-11-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: results of isolated head trauma
timeFrame: following maximum time for 6 months, until each pregnant's birth
measure: birth results
timeFrame: following maximum time for 6 months, until each pregnant's birth
measure: preterm birth results
timeFrame: following maximum time for 6 months, until each pregnant's birth
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Sanliurfa Training and Research Hospital
Study officials:
affiliation: Sanliurfa Training and Research Hospital
name: Alev Esercan, Assoc. Prof.
role: STUDY_DIRECTOR
References: