The Relationship Between Isolated Head Trauma During Pregnancy and Preterm Birth (PB)

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.

Study Overview

• Status: Completed
• Conditions: Superficial Injuries Involving Head With Neck

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 Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey
  • Şanlıurfa, Turkey
    • sanliurfa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
pregnant patients after first trimester without any complaint; Patients with a similar age and gestational age, who were not exposed to any trauma, who had no health problems, and who applied to the outpatient clinic for follow-up were randomized with a computer program and formed a control group. The birth week, birth weight, type of birth, and admission to the neonatal intensive care unit of the control group were evaluated.
isolated head trauma and pregnancy group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
results of isolated head trauma	CT/MRI result of the patients' head trauma, whether they had surgery on the brain after the trauma, ward or intensive care hospitalizations	following maximum time for 6 months, until each pregnant's birth
birth results	gestational week at birth	following maximum time for 6 months, until each pregnant's birth
preterm birth results	whether preterm birth occurs, the baby's delivery method and weight	following maximum time for 6 months, until each pregnant's birth

Collaborators and Investigators

• Sponsor: Sanliurfa Education and Research Hospital
• Investigators: Study Director: Alev Esercan, Assoc. Prof., sanliurfa Training and Research Hospital

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): February 2, 2024
• Study Completion (Actual): March 2, 2024

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 10, 2024
• First Posted (Estimated): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 10, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: preterm birth; placental abruption; head trauma; cervical dilatation; vaginal bleeding
• Additional Relevant MeSH Terms: Urogenital Diseases; Nervous System Diseases; Wounds and Injuries; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Trauma, Nervous System; Premature Birth; Craniocerebral Trauma
• Other Study ID Numbers: SEAH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No