- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01461187
Effects in Type of Birth of Physical Exercise During Pregnancy
Abstract:
Objectives:[The goal is] to confirm if physical activity of medium intensity performed during gestation can influence the way of delivery, and observe the adherence to exercise among pregnant women with different education levels. Methods: Held at the Center for Breastfeeding Incentive in the city of São Sebastião, State of São Paulo (Brazil), between April 7, 2008 and April 14, 2009, the prospective study involved 66 primigravid women, who were divided into two groups: the exercise group (GE) that exercised regularly during pregnancy, and the other control group (GC) that did not exercise regularly during same period. The significance level adopted in this study was five per cent (p = 0.05).
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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São Paulo
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São Sebastião, São Paulo, 브라질, 11600-000
- center of encouraging breastfeeding (CIAMA)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
The inclusion criteria:
- nulliparae,
- sedentary women,
- ages between 18 and 30,
- gestation age superior to 18 weeks without clinical or obstetrical complications
Exclusion Criteria:
The volunteers in the GE couldn't have a gestation age superior to 20 weeks, had to participate on regular physical activity twice a week, and have a total frequency of at least 20 sessions. The EG pregnant women with frequency inferior to 20 sessions were discarded from the study.
The volunteers in the CG couldn't have performed regular physical activity during pregnancy. In both groups, the participants hadn't performed regular physical activity in the year prior to the pregnancy.
However, 31 women were discarded during the research: three for miscarriage, being two from the GE and one from the GC; one from the GE for anemia; one from the GC for pre-eclampsia; two for loss of contact after birth, being one from each group; 11 from the GE for not reaching the minimum frequency; seven claimed personal reasons for leaving the research, being five from the GC and two from the GE; and six participants abandoned the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: exercise in pregnancy
37 pregnant women who performed supervised aerobic physical exercises twice a week
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supervised aerobic physical exercises twice a week.
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간섭 없음: Control group
29 pregnant women who had not performed any kind of physical activity during pregnancy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Predomination of type of birth, vaginal birth or Cesarean section among pregnant women participating in the exercise group and the control group.
기간: Research conducted between April 7, 2008 and April 14, 2009 (one year)
|
Of the 66 volunteers, 37 were part of the exercise group (EG) and 29 of the control group (CG).
Of the 37 in the control group, 25 had vaginal birth, while 12 had a Cesarean.
In contrast, of the 29 in the CG, 11 had vaginal birth and 18 had a Cesarean.
|
Research conducted between April 7, 2008 and April 14, 2009 (one year)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adhesion to exercise among the pregnant women with undergraduate and elementary education.
기간: The investigation lasted for one year
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Of the 66 volunteers, 12 had undergraduate education.
Of these, 11 were part of the EG and one of the CG.
In contrast, 15 of the 66 pregnant volunteers had primary education, six of which were part of the EG, while nine were part of the CG.
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The investigation lasted for one year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Lílian Cristina da Silveira, hostital public servant's state sao paulo (HSPE)
간행물 및 유용한 링크
일반 간행물
- Morkved S, Bo K, Schei B, Salvesen KA. Pelvic floor muscle training during pregnancy to prevent urinary incontinence: a single-blind randomized controlled trial. Obstet Gynecol. 2003 Feb;101(2):313-9. doi: 10.1016/s0029-7844(02)02711-4.
- San Juan Dertkigil M, Cecatti JG, Sarno MA, Cavalcante SR, Marussi EF. Variation in the amniotic fluid index following moderate physical activity in water during pregnancy. Acta Obstet Gynecol Scand. 2007;86(5):547-52. doi: 10.1080/00016340601181649.
- Artal R, O'Toole M. Guidelines of the American College of Obstetricians and Gynecologists for exercise during pregnancy and the postpartum period. Br J Sports Med. 2003 Feb;37(1):6-12; discussion 12. doi: 10.1136/bjsm.37.1.6. No abstract available.
- Villar J, Carroli G, Zavaleta N, Donner A, Wojdyla D, Faundes A, Velazco A, Bataglia V, Langer A, Narvaez A, Valladares E, Shah A, Campodonico L, Romero M, Reynoso S, de Padua KS, Giordano D, Kublickas M, Acosta A; World Health Organization 2005 Global Survey on Maternal and Perinatal Health Research Group. Maternal and neonatal individual risks and benefits associated with caesarean delivery: multicentre prospective study. BMJ. 2007 Nov 17;335(7628):1025. doi: 10.1136/bmj.39363.706956.55. Epub 2007 Oct 30.
- Gerten KA, Coonrod DV, Bay RC, Chambliss LR. Cesarean delivery and respiratory distress syndrome: does labor make a difference? Am J Obstet Gynecol. 2005 Sep;193(3 Pt 2):1061-4. doi: 10.1016/j.ajog.2005.05.038.
- Chalmers B. WHO appropriate technology for birth revisited. Br J Obstet Gynaecol. 1992 Sep;99(9):709-10. doi: 10.1111/j.1471-0528.1992.tb13867.x.
- Bungum TJ, Peaslee DL, Jackson AW, Perez MA. Exercise during pregnancy and type of delivery in nulliparae. J Obstet Gynecol Neonatal Nurs. 2000 May-Jun;29(3):258-64. doi: 10.1111/j.1552-6909.2000.tb02047.x.
- Cavalcante SR, Cecatti JG, Pereira RI, Baciuk EP, Bernardo AL, Silveira C. Water aerobics II: maternal body composition and perinatal outcomes after a program for low risk pregnant women. Reprod Health. 2009 Jan 6;6:1. doi: 10.1186/1742-4755-6-1.
- Zeanah M, Schlosser SP. Adherence to ACOG guidelines on exercise during pregnancy: effect on pregnancy outcome. J Obstet Gynecol Neonatal Nurs. 1993 Jul-Aug;22(4):329-35. doi: 10.1111/j.1552-6909.1993.tb01813.x.
- ACOG Committee Obstetric Practice. ACOG Committee opinion. Number 267, January 2002: exercise during pregnancy and the postpartum period. Obstet Gynecol. 2002 Jan;99(1):171-3. doi: 10.1016/s0029-7844(01)01749-5.
- Juhl M, Andersen PK, Olsen J, Madsen M, Jorgensen T, Nohr EA, Andersen AM. Physical exercise during pregnancy and the risk of preterm birth: a study within the Danish National Birth Cohort. Am J Epidemiol. 2008 Apr 1;167(7):859-66. doi: 10.1093/aje/kwm364. Epub 2008 Feb 25.
- Liu J, Laditka JN, Mayer-Davis EJ, Pate RR. Does physical activity during pregnancy reduce the risk of gestational diabetes among previously inactive women? Birth. 2008 Sep;35(3):188-95. doi: 10.1111/j.1523-536X.2008.00239.x.
- Kardel KR, Kase T. Training in pregnant women: effects on fetal development and birth. Am J Obstet Gynecol. 1998 Feb;178(2):280-6. doi: 10.1016/s0002-9378(98)80013-6.
- Santos IA, Stein R, Fuchs SC, Duncan BB, Ribeiro JP, Kroeff LR, Carballo MT, Schmidt MI. Aerobic exercise and submaximal functional capacity in overweight pregnant women: a randomized trial. Obstet Gynecol. 2005 Aug;106(2):243-9. doi: 10.1097/01.AOG.0000171113.36624.86.
- Garshasbi A, Faghih Zadeh S. The effect of exercise on the intensity of low back pain in pregnant women. Int J Gynaecol Obstet. 2005 Mar;88(3):271-5. doi: 10.1016/j.ijgo.2004.12.001. Epub 2005 Jan 16.
- Exercise during pregnancy and the postpartum period. ACOG Technical Bulletin Number 189--February 1994. Int J Gynaecol Obstet. 1994 Apr;45(1):65-70.
- Watson WJ, Katz VL, Hackney AC, Gall MM, McMurray RG. Fetal responses to maximal swimming and cycling exercise during pregnancy. Obstet Gynecol. 1991 Mar;77(3):382-6.
- Dwarkanath P, Muthayya S, Vaz M, Thomas T, Mhaskar A, Mhaskar R, Thomas A, Bhat S, Kurpad A. The relationship between maternal physical activity during pregnancy and birth weight. Asia Pac J Clin Nutr. 2007;16(4):704-10.
- Ellington C, Katz VL, Watson WJ, Spielman FJ. The effect of lateral tilt on maternal and fetal hemodynamic variables. Obstet Gynecol. 1991 Feb;77(2):201-3. doi: 10.1097/00006250-199102000-00007.
- Salles-Costa R, Werneck GL, Lopes CS, Faerstein E. [The association between socio-demographic factors and leisure-time physical activity in the Pro-Saude Study]. Cad Saude Publica. 2003 Jul-Aug;19(4):1095-105. doi: 10.1590/s0102-311x2003000400031. Epub 2003 Sep 8. Portuguese.
- Fell DB, Joseph KS, Armson BA, Dodds L. The impact of pregnancy on physical activity level. Matern Child Health J. 2009 Sep;13(5):597-603. doi: 10.1007/s10995-008-0404-7. Epub 2008 Aug 22.
- Shearer EL. Cesarean section: medical benefits and costs. Soc Sci Med. 1993 Nov;37(10):1223-31. doi: 10.1016/0277-9536(93)90334-z.
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (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. .
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