- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02109588
Early Prevention of Childhood Obesity: an Active Pregnancy
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Madrid, 스페인, 28040
- 모병
- Universidad Politécnica de Madrid
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연락하다:
- María Perales Santaella, PhD student
- 전화번호: 913364081
- 이메일: m.perales.santaella@gmail.com
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연락하다:
- Ruben Barakat, PhD
- 전화번호: 913364120
- 이메일: barakatruben@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Being able to communicate in spanish
- Giving birth at Hospital Universitario de Torrejón, hospital Universitario de Puerta de Hierro and Hospital Universitario Severo Ochoa (Madrid).
Exclusion Criteria:
- Multiparity
- Obstetrician complications
- Being interested in the study after 16 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 제어
앉아있는 임산부
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실험적: Exercise group
Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate |
Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body mass index of the offsprings
기간: 0-24 postpartum months
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Body mass index was measured several times from 0 to 24 months
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0-24 postpartum months
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Fetus body composition
기간: 0-24 postpartum months
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Fetus body composition (percentage of fat) was measured several times from 0 to 24 months
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0-24 postpartum months
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Change from baseline in Maternal gestational weight gain
기간: 40-42 weeks of gestation
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Maternal weight gain during pregnancy
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40-42 weeks of gestation
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Changes in Baby motor development
기간: 0-24 postpartum months
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Baby motor development was measured after delivery
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0-24 postpartum months
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Recovery time to pre-gestational weight
기간: 6-12 postpartum months
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The time needed to recovery the pre-gestational weight was assessed.
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6-12 postpartum months
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Glycemia level of the offsprings
기간: 0-24 postpartum months
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Glycemia level of the offsprings was measured until 24 months
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0-24 postpartum months
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Postpartum depression
기간: 0-12 postpartum months
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The level of maternal depression was measured after delivery
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0-12 postpartum months
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Change from baseline in Body image satisfaction
기간: up to 36 weeks
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Body image satisfaction was measured during and after pregnancy
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up to 36 weeks
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Changes from baseline in maternal quality of life
기간: up to 36 weeks
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Maternal quality of life was measured during and after pregnancy
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up to 36 weeks
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Placenta measurements
기간: At delivery
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Placenta measurements were collected at labor
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At delivery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maternal outcomes
기간: At delivery
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Type of labor, stage of labor and some other maternal variables were measured at delivery
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At delivery
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Control of physical activity
기간: up to 10 weeks
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Control the level of physical activity during and after pregnancy
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up to 10 weeks
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Changes from delivery in Health of the offspring
기간: 0-24 postpartum months
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Health of the baby included the measurement of other variables such as blood pressure and cholesterol of the offsprings until 24 months
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0-24 postpartum months
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Fetus outcomes
기간: At delivery
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Fetus outcomes were measured at delivery: Apgar score, PH umbilical cord, size and height of the baby, head circumference
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At delivery
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .
임신에 대한 임상 시험
-
The Nazareth Hospital, Israel완전한Streptococcus B Carrier State Complicating Pregnancy이스라엘
A supervised physical exercise program에 대한 임상 시험
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