Vitamin D in Ectopic Pregnancies | NCT03894735

Studies
Vitamin D in Ectopic Pregnancies

NCT03894735

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Mar 29, 2019Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Ectopic Pregnancy
Vitamin D Deficiency

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2015Actual

Primary Completion Date

Jun 1, 2017Actual

Completion Date

Jun 1, 2017Actual

First Submitted Date

Mar 27, 2019

First Submission Date that Met QC Criteria

Mar 27, 2019

First Posted Date

Mar 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2019

Last Update Posted Date

Mar 29, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pınar Kadirogulları, Principal investigator, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	first trimester

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ectopic pregnancies and
women with normal 1st trimester pregnancies

Exclusion Criteria:

Patients without any known operations or
disease history

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

ectopic pregnancies and women with normal 1st trimester pregnancies

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanuni Sultan Süleyman Training and Research Hospital		Istanbul		33404	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D011271	Pregnancy, Ectopic
D014808	Vitamin D Deficiency
D007249	Inflammation

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001361	Avitaminosis

Browse Leaves

Not provided

Browse Branches

Not provided