- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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).
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo
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São Sebastião, São Paulo, Brazil, 11600-000
- center of encouraging breastfeeding (CIAMA)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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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No Intervention: Control group
29 pregnant women who had not performed any kind of physical activity during pregnancy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predomination of type of birth, vaginal birth or Cesarean section among pregnant women participating in the exercise group and the control group.
Time Frame: Research conducted between April 7, 2008 and April 14, 2009 (one year)
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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.
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Research conducted between April 7, 2008 and April 14, 2009 (one year)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adhesion to exercise among the pregnant women with undergraduate and elementary education.
Time Frame: 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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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lílian Cristina da Silveira, hostital public servant's state sao paulo (HSPE)
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Líliancsilveira
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