NCT04455256

Brief Summary

To evaluate endoplasmic reticulum stress in women with recurrent pregnancy loss and those who had healthy births in the same age group. The level of the unfolded protein X box binding protein 1 (XBP-1) is measured. It is aimed to show the effect of endoplasmic reticulum stress on recurrent pregnancy loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

March 20, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2020

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2020

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

June 28, 2020

Last Update Submit

July 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Show the effect of endoplasmic reticulum stress on recurrent pregnancy loss

    Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.

    3 months

Study Arms (2)

recurrent pregnancy loss group

Women between the ages of 18 and 45 who had a history of miscarriage under 3 weeks and above 22 weeks were included in this group.

Other: x box binding protein

women who had healthy birth

Women between the ages of 18-45 who have not had a history of pregnancy loss and who have had at least one healthy birth and no known chronic diseases are included in this group.

Other: x box binding protein

Interventions

Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.

recurrent pregnancy loss groupwomen who had healthy birth

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Loss of 3 or more pregnancy between the ages of 18 and 45 and women who have given at least 1 healthy birth in the same age group.

You may qualify if:

  • with three or more miscarriages before 20 th week of gestation
  • had no chronic or acute inflammatory disease
  • used no steroids, anti-inflammatory, or antioxidant medications

You may not qualify if:

  • had inflammatory diseases
  • had systemic disease
  • Anatomical abnormalities, infectious, endocrine, or genetic etiologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 2, 2020

Study Start

March 20, 2020

Primary Completion

July 1, 2020

Study Completion

July 7, 2020

Last Updated

July 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Locations