NCT01461187

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Apr 2008

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
Last Updated

October 27, 2011

Status Verified

October 1, 2011

Enrollment Period

9 months

First QC Date

October 4, 2011

Last Update Submit

October 26, 2011

Conditions

Keywords

ExercisePregnancyChildbirthVaginalCesarean section

Outcome Measures

Primary Outcomes (1)

  • Predomination of type of birth, vaginal birth or Cesarean section among pregnant women participating in the exercise group and the control group.

    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)

Secondary Outcomes (1)

  • Adhesion to exercise among the pregnant women with undergraduate and elementary education.

    The investigation lasted for one year

Study Arms (2)

exercise in pregnancy

EXPERIMENTAL

37 pregnant women who performed supervised aerobic physical exercises twice a week

Other: exercise during pregnancy

Control group

NO INTERVENTION

29 pregnant women who had not performed any kind of physical activity during pregnancy

Interventions

supervised aerobic physical exercises twice a week.

exercise in pregnancy

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • nulliparae,
  • sedentary women,
  • ages between 18 and 30,
  • gestation age superior to 18 weeks without clinical or obstetrical complications

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

center of encouraging breastfeeding (CIAMA)

São Sebastião, São Paulo, 11600-000, Brazil

Location

Related Publications (22)

  • 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.

    PMID: 17977819BACKGROUND
  • 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.

    PMID: 16157112BACKGROUND
  • 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.

    PMID: 1420006BACKGROUND
  • 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.

    PMID: 10839574BACKGROUND
  • 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.

    PMID: 19126239BACKGROUND
  • 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.

    PMID: 8410432BACKGROUND
  • 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.

    PMID: 11777528BACKGROUND
  • 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.

    PMID: 12547738BACKGROUND
  • 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.

    PMID: 18303008BACKGROUND
  • 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.

    PMID: 17464582BACKGROUND
  • 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.

    PMID: 18844644BACKGROUND
  • 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.

    PMID: 9500487BACKGROUND
  • 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.

    PMID: 16055571BACKGROUND
  • 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.

    PMID: 15733880BACKGROUND
  • 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.

    PMID: 12576255BACKGROUND
  • Exercise during pregnancy and the postpartum period. ACOG Technical Bulletin Number 189--February 1994. Int J Gynaecol Obstet. 1994 Apr;45(1):65-70.

    PMID: 7913067BACKGROUND
  • 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.

    PMID: 1992404BACKGROUND
  • 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.

    PMID: 18042532BACKGROUND
  • 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.

    PMID: 1988881BACKGROUND
  • 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.

    PMID: 12973574BACKGROUND
  • 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.

    PMID: 18719984BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lílian Cristina da Silveira

    hostital public servant's state sao paulo (HSPE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist master's degree in health sciences

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 27, 2011

Study Start

April 1, 2008

Primary Completion

January 1, 2009

Study Completion

April 1, 2009

Last Updated

October 27, 2011

Record last verified: 2011-10

Locations