Evaluation of Endoplasmic Reticulum Stress in Patients With Recurrent Pregnancy Loss

Endoplasmic Reticulum Stress in Recurrent Pregnancy Loss

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Pregnancy Loss; Endoplasmic Reticulum Stress
• Intervention / Treatment: Other: x box binding protein

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey, 34000
      • Pinar Yalcin Bahat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2020
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): July 7, 2020

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: June 28, 2020
• First Posted (ACTUAL): July 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Death; Recurrence; Abortion, Spontaneous; Abortion, Habitual; Fetal Death
• Other Study ID Numbers: tgk-xbp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No