Effects in Type of Birth of Physical Exercise During Pregnancy

Pregnancy Clinical Trial

Official title:

Effects in Type of Birth of Physical Exercise During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461187
• Other study ID #: Líliancsilveira
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: October 26, 2011
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: October 2011
• Source: Hospital do Servidor Publico Estadual
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

Description:

Research was conducted at the Maternal Breastfeeding Incentive Center (Centro de Incentivo ao Aleitamento Materno - CIAMA) in São Sebastião, São Paulo, Brazil. The 66 primigravidas were allocated to two groups: a control group, with 29 pregnant women who had not performed any kind of physical activity during pregnancy, and another group, the exercise group, with 37 pregnant women who performed supervised aerobic physical exercises twice a week. These volunteers needed to attend at least 20 sessions to be included in the research. No pregnant women in the control group or the exercise group had performed regular physical activity in the year prior to the pregnancy. All participants received verbal information on how the research would be conducted, and after agreeing to participate they signed a free and informed consent term. The physical activity was prescribed by a physical therapist who remained available to address any doubts about the physical activity and about the research. The study followed the baselines of the American Congress of Obstetricians and Gynecologists (ACOG), where the environment temperature hasn't exceeded 28 °C. The pregnant women were told to wear comfortable clothes and to drink water before and during the activity, and not to perform physical activity while fasting. They were also instructed to interrupt the activity in case they felt dizziness, breathlessness, pain, muscle weakness, dyspnea prior to effort or in case they presented calf swelling or pain, bleeding or signs of labor, or, still, if they noticed decrease in fetal movements. Two weeks after birth the volunteers were contacted by phone to collect information on the type of birth.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• exercise during pregnancy
supervised aerobic physical exercises twice a week.

Locations

Country	Name	City	State
Brazil	center of encouraging breastfeeding (CIAMA)	São Sebastião	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Servidor Publico Estadual	Maternal Breastfeeding Incentive Center (CIAMA)

Country where clinical trial is conducted

Brazil, 

References & Publications (22)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Chalmers B. WHO appropriate technology for birth revisited. Br J Obstet Gynaecol. 1992 Sep;99(9):709-10. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Epub 2005 Jan 16. — View Citation

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. — View Citation

Juhl M, Andersen PK, Olsen J, Madsen M, Jørgensen T, Nøhr 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. — View Citation

Kardel KR, Kase T. Training in pregnant women: effects on fetal development and birth. Am J Obstet Gynecol. 1998 Feb;178(2):280-6. — View Citation

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. — View Citation

Mørkved S, Bø 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. — View Citation

Salles-Costa R, Werneck GL, Lopes CS, Faerstein E. [The association between socio-demographic factors and leisure-time physical activity in the Pró-Saúde Study]. Cad Saude Publica. 2003 Jul-Aug;19(4):1095-105. Epub 2003 Sep 8. Portuguese. — View Citation

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. — View Citation

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. — View Citation

Shearer EL. Cesarean section: medical benefits and costs. Soc Sci Med. 1993 Nov;37(10):1223-31. Review. — View Citation

Villar J, Carroli G, Zavaleta N, Donner A, Wojdyla D, Faundes A, Velazco A, Bataglia V, Langer A, Narváez A, Valladares E, Shah A, Campodónico L, Romero M, Reynoso S, de Pádua 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. Epub 2007 Oct 30. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Adhesion to exercise among the pregnant women with undergraduate and elementary education.	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.	The investigation lasted for one year	No

External Links

•   link related to support groups for normal delivery