PregnancyNCT01461187
Effects in Type of Birth of Physical Exercise During Pregnancy
A study testing exercise during pregnancy in people with Pregnancy, run by Hospital do Servidor Publico Estadual at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- exercise during pregnancy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2008to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
center of encouraging breastfeeding (CIAMA)
São Sebastião, São Paulo, 11600-000
About this study
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).
Read the detailed 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.
- Conditions
- Pregnancy
- Being tested
- exercise during pregnancy
- Keywords
- Exercise, Pregnancy, Childbirth, Vaginal, Cesarean section
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise during pregnancyOther
supervised aerobic physical exercises twice a week.
| Study group | Role | What they receive |
|---|---|---|
| exercise in pregnancy | Experimental | 37 pregnant women who performed supervised aerobic physical exercises twice a week Receives: Other: exercise during pregnancy |
| Control group | No intervention | 29 pregnant women who had not performed any kind of physical activity during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: The investigation lasted for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Servidor Publico Estadual
- Sponsor type
- University, hospital or other
- Collaborators
- Maternal Breastfeeding Incentive Center (CIAMA)
- Responsible party
- Principal investigator, Lilian Cristina da Silveira, Hospital do Servidor Publico Estadual
- Investigators
- Lílian Cristina da Silveira, Principal investigator, hostital public servant's state sao paulo (HSPE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461187
- Sponsor's protocol ID
- Líliancsilveira
- Status last verified
- Oct 2011
- First submitted
- 4 Oct 2011
- Last updated
- 27 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17977819Gerten 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.
PubMed 16157112Chalmers 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.
PubMed 1420006Bungum 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.
PubMed 10839574Cavalcante 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.
PubMed 19126239Zeanah 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.
PubMed 8410432ACOG 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.
PubMed 11777528Artal 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.
PubMed 12547738Juhl 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.
PubMed 18303008San 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.
PubMed 17464582Liu 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.
PubMed 18844644Kardel 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.
PubMed 9500487Santos 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.
PubMed 16055571Garshasbi 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.
PubMed 15733880Morkved 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.
PubMed 12576255
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects in Type of Birth of Physical Exercise During Pregnancy
- ClinicalTrials.gov ID
- NCT01461187
- Acronym / sponsor ID
- Líliancsilveira
- Conditions
- Pregnancy
- Keywords
- Exercise, Pregnancy, Childbirth, Vaginal, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hospital do Servidor Publico EstadualUniversity, hospital or other
- Collaborators
- Maternal Breastfeeding Incentive Center (CIAMA)
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise in pregnancy | Experimental | Other: exercise during pregnancy37 pregnant women who performed supervised aerobic physical exercises twice a week |
| Control group | No intervention | –29 pregnant women who had not performed any kind of physical activity during pregnancy |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise during pregnancysupervised aerobic physical exercises twice a week. | Other | exercise in pregnancy |
Primary outcome
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)
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.
1 secondary outcome
Adhesion to exercise among the pregnant women with undergraduate and elementary education.
Time frame: The investigation lasted for one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2011.
- Background: PubMed 17977819Villar 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.
- Background: PubMed 16157112Gerten 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.
- Background: PubMed 1420006Chalmers 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.
- Background: PubMed 10839574Bungum 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.
- Background: PubMed 19126239Cavalcante 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.
- Background: PubMed 8410432Zeanah 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.
- Background: PubMed 11777528ACOG 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.
- Background: PubMed 12547738Artal 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.
- Background: PubMed 18303008Juhl 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.
- Background: PubMed 17464582San 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.
- Background: PubMed 18844644Liu 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.
- Background: PubMed 9500487Kardel 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.
- link related to support groups for normal deliveryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lílian Cristina da Silveira principal investigator
hostital public servant's state sao paulo (HSPE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise during pregnancy in people with Pregnancy, run by Hospital do Servidor Publico Estadual at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01461187, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2011.