Evaluation of Endoplasmic Reticulum Stress in Patients With Recurrent Pregnancy Loss
Endoplasmic Reticulum Stress in Recurrent Pregnancy Loss
1 other identifier
observational
90
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
June 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2020
CompletedJuly 16, 2020
July 1, 2020
3 months
June 28, 2020
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.
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.
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.
Eligibility Criteria
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)
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