Maternal Serum BLyS Levels Throughout Pregnancy

NCT03364712 | Completed

• 1 other identifier: #HS-11-00449
• Study Type: observational
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background and rationale: B lymphocyte stimulator (BLyS) is a potent B cell survival factor that has been found to be elevated in patients with inflammatory conditions, such as systemic lupus and rheumatoid arthritis. Because of the immunologic changes associated with pregnancy, including changes in levels of T and B lymphocytes, it is postulated that BLyS levels would be altered in pregnancy compared to the non-pregnant state. Objectives: The primary objective of this study is to assess the levels of BLyS in each trimester of pregnancy. Secondary objectives include evaluation of an association between BLyS levels and adverse pregnancy events; comparison of BLyS levels between healthy pregnant women and pregnant women with a medical or obstetric conditions; and, assessment of APRIL levels and comparison between APRIL levels and BLyS levels in study subjects. Study population: Pregnant and non-pregnant women receiving care in the outpatient Obstetrics and Gynecology clinics at LAC+USC Medical Center. Study methodology: Peripheral blood samples will be drawn from pregnant women and non-pregnant controls. Pregnant women will have blood drawn each trimester, at delivery, and postpartum, and control subjects will have blood drawn once, upon enrollment in the study. Study outcomes: BLyS and APRIL levels during each trimester, postpartum and in cord blood will be compared between healthy pregnant women, pregnant women with a medical condition, and healthy non-pregnant controls. Additionally, pregnancy outcomes will be recorded to determine whether BLyS or APRIL levels correlate with adverse events. Statistics: Continuous data will be analyzed by Student t-test or logistic regression, where appropriate. Categorical data will be analyzed using Chi square.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (5)

• first-trimester serum blys level

  maternal serum blys level during the first trimester of pregnancy

  up to 13 weeks of pregnancy (first trimester)

• second-trimester serum blys level

  maternal serum blys level during the second trimester of pregnancy

  from 14 through 26 weeks of pregnancy (second trimester)

• third-trimester serum blys level

  maternal serum blys level during the third trimester of pregnancy

  from 27 weeks of pregnancy through delivery of baby (third trimester of pregnancy)

• cord blood serum blys level

  serum blys level in cord blood obtained at delivery

  delivery of baby

• post-partum serum blys level

  maternal serum blys level post-partum

  1-2 days post-partum

Study Arms (2)

pregnant

Pregnant women receiving routine medical care, including venipuncture.

Other: routine medical care, venipuncture

non-pregnant

Women not pregnant receiving routine medical care, including venipuncture.

Other: routine medical care, venipuncture

Interventions

routine medical care, venipuncture OTHER

non-pregnant; pregnant

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women seen at a single medical center

You may qualify if:

• Adult woman

You may not qualify if:

• Unable to give informed consent

Sponsors & Collaborators

• University of Southern California: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Banked sera.

MeSH Terms

Interventions

Phlebotomy

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: December 6, 2017
• Study Start: September 19, 2011
• Primary Completion: June 30, 2014
• Study Completion: June 30, 2014
• Last Updated: December 6, 2017

Record last verified: 2017-11