Superficial Injuries Involving Head With NeckPBNCT06685549
The Relationship Between Isolated Head Trauma During Pregnancy and Preterm Birth
An observational study of Superficial Injuries Involving Head With Neck, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Superficial Injuries Involving Head With Neck
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 2 Mar 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sanliurfa Training and Research Hospital
Sanliurfa
About this study
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.
Read the 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.
- Keywords
- cervical dilatation, head trauma, preterm birth, placental abruption, vaginal bleeding
- Medical subject headings
- Craniocerebral Trauma, Premature Birth, Abruptio Placentae, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: following maximum time for 6 months, until each pregnant's birth
birth results
gestational week at birth
Measured: 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
Measured: following maximum time for 6 months, until each pregnant's birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jan 2018
- Primary completion2 Feb 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Injuries Involving Head With NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alev Esercan, Sanliurfa Education and Research Hospital
- Investigators
- Alev Esercan, Assoc. Prof., Study director, Sanliurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685549
- Sponsor's protocol ID
- SEAH
- Acronym
- PB
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Isolated Head Trauma During Pregnancy and Preterm Birth
- ClinicalTrials.gov ID
- NCT06685549
- Acronym / sponsor ID
- PB / SEAH
- Keywords
- cervical dilatation, head trauma, preterm birth, placental abruption, vaginal bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alev Esercan, Assoc. Prof. study director
Sanliurfa Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superficial Injuries Involving Head With Neck, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
results of isolated head trauma (time frame: following maximum time for 6 months, until each pregnant's birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.