Adolescent DevelopmentNCT04546204
COMPARISON OF OBSTETRIC AND NEONATAL OUTCOMES OF ADOLESCENT PREGNANCİES
An observational study of Adolescent Development and Pregnancy Related, run by Alkü Alanya Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
ABSTRACT Adolescent pregnancy rates are gradually increasing in the recent decades. As a reason of war nutritional difficulties, language differences and difficulty in applying to the health institution causes lack of prenatal care. As a reason of absence of prenatal care, associated medical complications can occur. Read more about this study
- Who is it for?
- Ages 14 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Development, Pregnancy Related
- What is being tested?
- vaginal delivery
- How many people
- 525 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Sep 2020
- 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 14 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Study population: adolescent pregnancy outcomes
Who may be able to join
- 14-16 y Age
Who cannot join
- over 16 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF OBSTETRIC AND NEONATAL OUTCOMES BETWEEN SYRIAN ADOLESCENT REFUGEES AND LOCAL TURKISH ADOLESCENT CITIZENS.
ABSTRACT
Adolescent pregnancy rates are gradually increasing in the recent decades. As a reason of war nutritional difficulties, language differences and difficulty in applying to the health institution causes lack of prenatal care. As a reason of absence of prenatal care, associated medical complications can occur. 525 adolescent women who gave birth to singletons agreed to participate in this study. Data on maternal demographic and obstetric characteristics as well as neonatal outcomes were analyzed. In conclusion, adolescent pregnancy continues to be an important social problem due to the health support needs. However, the results of our present study are important in terms of showing that the perinatal care is quietly improved in Turkey.
- Conditions
- Adolescent Development, Pregnancy Related
- Being tested
- vaginal delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal deliveryOther
normal vaginal spontaneous delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
vaginal delivery rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start1 Jun 2020
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent DevelopmentStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkü Alanya Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERAL TUĞBA ÇİMŞİR, Alkü Alanya Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546204
- Sponsor's protocol ID
- adolescentpregnancy
- Status last verified
- Sep 2020
- First submitted
- 6 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF OBSTETRIC AND NEONATAL OUTCOMES BETWEEN SYRIAN ADOLESCENT REFUGEES AND LOCAL TURKISH ADOLESCENT CITIZENS.
- ClinicalTrials.gov ID
- NCT04546204
- Acronym / sponsor ID
- adolescentpregnancy
- Conditions
- Adolescent Development, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- Alkü Alanya Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 11 Sep 2020 (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.
ABSTRACT
Adolescent pregnancy rates are gradually increasing in the recent decades. As a reason of war nutritional difficulties, language differences and difficulty in applying to the health institution causes lack of prenatal care. As a reason of absence of prenatal care, associated medical complications can occur. 525 adolescent women who gave birth to singletons agreed to participate in this study. Data on maternal demographic and obstetric characteristics as well as neonatal outcomes were analyzed. In conclusion, adolescent pregnancy continues to be an important social problem due to the health support needs. However, the results of our present study are important in terms of showing that the perinatal care is quietly improved in Turkey.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- adolescent pregnancy outcomes
Key inclusion criteria (1 listed)
- 14-16 y Age
Key exclusion criteria (1 listed)
- over 16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal deliverynormal vaginal spontaneous delivery | Other | – |
Primary outcome
vaginal delivery rate
Time frame: 2 years
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 14 Sep 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adolescent Development and Pregnancy Related, run by Alkü Alanya 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 1 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 14 Sep 2020. 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?
vaginal delivery rate (time frame: 2 years). 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 14 Sep 2020.