Ectopic PregnancyNCT03894735
Vitamin D in Ectopic Pregnancies
An observational study of Ectopic Pregnancy and Vitamin D Deficiency, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
According to recent evidences, vitamin D was found to have important roles in female reproductive system, both in physiological and also pathological mechanisms. Since vitamin D is tightly related with calcium metabolism, both molecules were reported to be associated with some pregnancy complications including… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ectopic Pregnancy, Vitamin D Deficiency
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2015to 1 Jun 2017
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: ectopic pregnancies and women with normal 1st trimester pregnancies
Who may be able to join
- ectopic pregnancies and
- women with normal 1st trimester pregnancies
Who cannot join
- Patients without any known operations or
- disease history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: The Effect of Serum Vitamin D and Calcium Levels in Ectopic Pregnancies
According to recent evidences, vitamin D was found to have important roles in female reproductive system, both in physiological and also pathological mechanisms. Since vitamin D is tightly related with calcium metabolism, both molecules were reported to be associated with some pregnancy complications including preeclampsia, gestational diabetes, low birth weight, preterm delivery, and cesarean section rates. The aim of the present study was to evaluate the vitamin D levels in ectopic pregnancies, which may have clinical importance in the etiology of this disorder.
- Conditions
- Ectopic Pregnancy, Vitamin D Deficiency
- Keywords
- Calcium, Magnesium, Inflammation
- Medical subject headings
- Pregnancy, Ectopic, Vitamin D Deficiency, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin D level
vitamin d level value will be evaluated in ectopic pregnancies. 25-OH vitamin D (ng / ml) will be looked at in terms of vitamin levels.
Measured: at the time of diagnosis of ectopic pregnancy
vitamin D level
vitamin d level value will be evaluated in first trimester. 25-OH vitamin D (ng / ml) will be looked at in terms of vitamin levels.
Measured: first trimester
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Oct 2015
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894735
- Sponsor's protocol ID
- 2018.08.11
- Status last verified
- Mar 2019
- First submitted
- 27 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Serum Vitamin D and Calcium Levels in Ectopic Pregnancies
- ClinicalTrials.gov ID
- NCT03894735
- Acronym / sponsor ID
- 2018.08.11
- Conditions
- Ectopic Pregnancy, Vitamin D Deficiency
- Keywords
- Calcium, Magnesium, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 28 Mar 2019 (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.
According to recent evidences, vitamin D was found to have important roles in female reproductive system, both in physiological and also pathological mechanisms. Since vitamin D is tightly related with calcium metabolism, both molecules were reported to be associated with some pregnancy complications including preeclampsia, gestational diabetes, low birth weight, preterm delivery, and cesarean section rates. The aim of the present study was to evaluate the vitamin D levels in ectopic pregnancies, which may have clinical importance in the etiology of this disorder.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ectopic pregnancies and women with normal 1st trimester pregnancies
Key inclusion criteria (2 listed)
- ectopic pregnancies and
- women with normal 1st trimester pregnancies
Key exclusion criteria (2 listed)
- Patients without any known operations or
- disease history
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
vitamin D level
Time frame: at the time of diagnosis of ectopic pregnancy
vitamin d level value will be evaluated in ectopic pregnancies. 25-OH vitamin D (ng / ml) will be looked at in terms of vitamin levels.
vitamin D level
Time frame: first trimester
vitamin d level value will be evaluated in first trimester. 25-OH vitamin D (ng / ml) will be looked at in terms of vitamin levels.
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 29 Mar 2019.
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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 Ectopic Pregnancy and Vitamin D Deficiency, run by Kanuni Sultan Suleyman Training 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 2 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 29 Mar 2019. 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?
vitamin D level (time frame: at the time of diagnosis of ectopic pregnancy). The study lists 2 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 29 Mar 2019.