- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07579468
Impact of Physical Activity During Pregnancy on Biological Markers at Birth in Cord Blood (CORDOMOUV) (CORDOMOUV)
Currently, an interventional protocol for physical activity during pregnancy is underway at the Clermont University Hospital (PREGMOUV study). In addition, we have implemented a protocol for 2 years monitoring of children birthed of this study (NEOMOUV study).
Recent data from the scientific literature show that a woman's engagement in regular and appropriate physical activity during her pregnancy presents few dangers while ensuring benefits for the mother-baby dyad. Indeed, physical activity reduces maternal complications such as preeclampsia, gestational diabetes and depression and has many advantages for the child with in particular a reduction in the risk of macrosomia then obesity and diabetes.
Neonatal sepsis is a major risk factor for childhood mortality. There is strong negative association between cord blood levels of calprotectin and sepsis risk in human newborns with levels of calprotectin at birth are significantly lower in infants that later experience blood-culture-proven late-onset neonatal sepsis. In adults, plasma calprotectin levels increase following acute exercise. However after 4 weeks trainging plasma calprotectin level decrease. So in response to acute exercise, plasma calprotectin levels increase but in contrast, there is a negative association between basal plasma calprotectin levels and regular physical activity. Therefore, we do not know what impact mother' regular physical activity can have on the level of calprotectin in the cord blood.
The objective of this project is to investigate the impact of physical activity during pregnancy on calprotectin value at cord blood.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Lise Laclautre
- 전화번호: +334752963
- 이메일: promo_interne_drci@chu-clermontferrand.fr
연구 장소
-
-
-
Clermont-Ferrand, 프랑스, 63000
- 모병
- CHU de Clermont-Ferrand
-
연락하다:
- Lise Laclautre
- 전화번호: +334754963
- 이메일: promo_interne_drci@chu-clermontferrand.fr
-
수석 연구원:
- Solène Fel
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Newborns born to mothers who participated in the PregMouv study (which aims to evaluate an intervention allowing women to better adhere to physical activity: program free/face-to-face/videoconference/mixed) and born at the Clermont Ferrand University Hospital.
Exclusion Criteria:
- If parents refuse to participate or in situations where parents are protected by law, cord blood collection cannot be done.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
cord blood
|
Total physical activity time (in MET minutes/week) of pregnant women measured at Trimestry 3 (explanatory variable)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Calprotectin levels
기간: at birth
|
Calprotectin levels (ng/mL), collected from cord blood immediately after birth according to Total physical activity time (in MET minutes/week) of pregnant women measured at Trimestry 3
|
at birth
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
calprotectin level
기간: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to delivery mode
|
at birth
|
|
calprotectin level
기간: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2
|
at birth
|
|
calprotectin level
기간: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to gestational age at birth
|
at birth
|
|
calprotectin level
기간: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3
|
at birth
|
|
calprotectin level
기간: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal body composition (kg/m²)
|
at birth
|
|
transcriptomic
기간: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
|
at birth
|
|
transciptomic
기간: at birth
|
mRNA expression level in umbilical cord blood at birth according to delivery mode
|
at birth
|
|
transciptomic
기간: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2
|
at birth
|
|
transciptomic
기간: at birth
|
mRNA expression level in umbilical cord blood at birth according to gestational age at birth
|
at birth
|
|
transciptomic
기간: at birth
|
mRNA expression level in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3
|
at birth
|
|
transciptomic
기간: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
|
at birth
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Solène FEL, University Hospital, Clermont-Ferrand
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RNI 2026 FEL
- 2026-A00010-51 (기타 식별자: ANSM)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .