NCT03894735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

March 27, 2019

Last Update Submit

March 28, 2019

Conditions

Ectopic PregnancyVitamin D Deficiency

Keywords

CalciumMagnesiumInflammation

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

ectopic pregnancies and women with normal 1st trimester pregnancies

You may qualify if:

  • ectopic pregnancies and
  • women with normal 1st trimester pregnancies

You may not qualify if:

  • Patients without any known operations or
  • disease history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy, EctopicVitamin D DeficiencyInflammation

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, M.D, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 27, 2019

First Posted

March 28, 2019

Study Start

October 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

March 29, 2019

Record last verified: 2019-03

Locations

TU(1)