The Relationship Between Isolated Head Trauma During Pregnancy and Preterm Birth

NCT06685549 | Completed

• 1 other identifier: SEAH
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Superficial Injuries Involving Head With Neck

Keywords

cervical dilatation; head trauma; preterm birth; placental abruption; vaginal bleeding

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanliurfa Education and Research Hospital: lead

Study Sites (1)

Sanliurfa Training and Research Hospital

Sanliurfa, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Craniocerebral Trauma; Premature Birth; Abruptio Placentae; Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alev Esercan, Assoc. Prof.

  Sanliurfa Education and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: January 1, 2018
• Primary Completion: February 2, 2024
• Study Completion: March 2, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

TU (1)