- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02273193
Utility Of Hemoglobin A1C For The Diagnosis Of Gestational Diabetes (A1cGDM)
Utility Of Hemoglobin A1C (HbA1C) For The Diagnosis Of Gestational Diabetes Mellitus (GDM).
연구 개요
상태
정황
상세 설명
This is a prospective cohort research study conducted in the Mike O'Callaghan Federal Medical Center (MOFMC), Department of Family Medicine Residency and Obstetrics Clinics. Subjects will be pregnant female active duty or DoD beneficiaries 18 years or older recruited from the MOFMC, Department of Family Medicine Residency Clinic, and Obstetrics Orientation Class at Nellis AFB. At the screening, the Research Assistant discusses the study, answers all questions, obtains Informed Consent, and schedules appointments for routine OB care. The research design includes a screening visit to obtain written consent and two (2) additional laboratory blood tests obtained during the standard of care prenatal screen testing during the first and second trimesters of pregnancy. Each laboratory blood test will be done via 1 venipuncture for 5-10 ml (1-2 teaspoons) of blood. The OB nurse orders all labs upon completion of the Obstetrics Orientation Class.
Screening Visit: Initial Standard of Care Obstetrics Appointment
- Obtain subject signed Informed Consent document and HIPAA Authorization
- Demographic data: age, race, weight, height, estimated week of gestation
- Review past medical history
First Trimester Prenatal Visit (<13 weeks) Screen Testing
- Subjects will have routine prenatal labs drawn to include the HbA1C blood test which is standard of care
- Subjects will have fasting (10 hour) glucose blood test will be ordered along with these labs (research driven)
Second Trimester Prenatal Visit (24-28 weeks)
- Subjects will have routine prenatal labs drawn to include the 2 hr glucose tolerance test (2 hr OGTT) which is standard of care
- Subjects will have will be the HbA1C blood test ordered along with these labs (research driven)
Delivery and Neonatal Data Collection
-Select data regarding delivery and neonatal health will be tracked. All of this data is already routinely collected as standard of care and will be found in the patient record. This will require no interaction with the patient or the neonate
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Nevada
-
Nellis Air Force Base, Nevada, 미국, 89191
- Mike O'Callaghan Federal Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.
Inclusion:
- Active duty or DoD beneficiaries of childbearing age 18 years or older with a positive pregnancy test (beta human chorionic gonadotropin).
Exclusion:
Active duty or DoD beneficiaries of childbearing age 18 years or older with a positive pregnancy test (beta human chorionic gonadotropin) known to have and/or develop during the study any of the following upon review of their medical record:
- Hemoglobinopathy (including sickle cell disease or trait, thalassemia)
- Chronic kidney disease
- Diabetes
- Active duty or DoD beneficiaries of childbearing age 18 years or older with a positive pregnancy test (beta human chorionic gonadotropin) taking any of the following:
- Erythropoietin
- Daily oral steroids
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
---|
Pregnant Women
Pregnant Women in the first trimester (<13 weeks) of pregnancy and the second trimester of pregnancy.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Fasting Glucose will be obtained during the first trimester of pregnancy
기간: 13 weeks
|
13 weeks
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Hemoglobin A1c will be obtained during the second trimester of pregnancy (between 24-28 weeks)
기간: 24-28 weeks
|
24-28 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .