LumbagoPhase 4NCT01155804
Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
A Phase 4 study testing preparation of the delivery in people with Lumbago and Anxiety, run by Center for Research on Reproductive Health of Campinas at 1 site in Brazil.
Trial summary
Introduction: randomized studies on programs implemented during pre-natal care that offer information and physical activities preparing pregnant women for delivery are scarce in the scientific literature. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- What is being tested?
- preparation of the delivery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2009to Oct 2011
- Phase
- Phase 4
- 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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women aged between 16 and 40 years old
- gestational age >20 weeks
- nulliparous women
- single fetus
- Performing pre-natal care.
Who cannot join
- Pathological heart condition
- diabetes
- hypertension
- asthma bronchial
- HIV+
- gestational hypertension
Show all 16Show fewer
- gestational diabetes
- pre-eclampsia
- persistent bleeding
- premature labor
- cervical incompetence
- acute infection with fever
- restriction in fetal growth
- indication of elective caesarian-section
- in psychotherapy
- performing other physical activity more than once a week.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Atençao Integral a Saude da Mulher CAISM
Campinas, São Paulo, 13084-971
Maria Y Makuch, Ph.D., 551932892856 ext. 220, mmakuch@cemicamp.org.br
Adriana Barros, 551932892856 ext. 209, abarros@cemicamp.org.br
About this study
Introduction: randomized studies on programs implemented during pre-natal care that offer information and physical activities preparing pregnant women for delivery are scarce in the scientific literature. Objective: to evaluate the effectively of the Program for Preparation of Pregnant Women for Delivery on the prevention of physical and psychological difficulties and problems during pregnancy and delivery in nulliparous women participating in the program. Subjects and methods: a randomized clinical single blind trial will be conducted with 192 pregnant nulliparous women allocated to participate or not of the program activities. The women allocated to the study group will participate of physical and educational activities at each pre-natal consultation and will receive orientation on the exercises they will perform at their home. Participants of the non-interventional group will follow the habitual routine care at the service. Participants will be selected among nulliparous low risk pregnant women aged between 16 and 40 years old after the 20th week of gestation. Data analysis: will be performing by intention to treat. For the continues variables the t-Student or Wilcoxon test will be performing; for the categorical variables the tests x² or Fisher, and the risk estimate will be estimated using a Relative Risk with 95% CI. ANOVA will be use for measures between the groups and along time, and correlation tests for anxiety and physical activity with gestational and perinatal variables.
Read the detailed description
Participants, 192 nulliparous women that receive pre-natal care, allocated according to randomization into two groups: group one in which the women who participate in a program with physical and educational activities and the non-interventional group that will not receive the intervention and will follow a regular pre-natal care at routine of the service. The designation of participants will be performed, after informed consent will be sign, by opening sequentially envelopes previously sealed and numbered that will contain the information, previously generated by a computer system.
- Being tested
- preparation of the delivery
- Keywords
- preparation of the delivery, lumbago, anxiety, urinary incontinence
- Medical subject headings
- Low Back Pain, Anxiety Disorders, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preparation of the deliveryBehavioural
Pregnant nulliparous women allocated to the non-interventional group will follow the routine pre-natal care. The participants of the study group will receive routine attention at the pre-natal care service and will also participate in the program of physical and educational after each routine pre-natal consultation. These activities will be organize as follow: 30 minutes of physical exercise for the prevention of pain and discomfort that may occur during pregnancy, preparation of the perineal muscles for delivery and prevention of urinary incontinence, 15 minutes for relaxation and 30 minutes for group discussion to respond to doubts that women may have and issues such as: change in posture during pregnancy and prevention of pain and discomfort; role of the perineal muscles during pregnancy, delivery and puerperium, physiology of delivery, non-pharmacological way for pain relief and breathing control during contractions of labor and delivery.
| Study group | Role | What they receive |
|---|---|---|
| Exercice | Other | Not described Receives: Behavioral: preparation of the delivery |
| non-exercice | Other | Not described Receives: Behavioral: preparation of the delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence
To evaluate a well being in women who were receive intense care during prenatal care by the proportion of women with back pain and those with stress urinary incontinence
Measured: The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionSep 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LumbagoStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Research on Reproductive Health of Campinas
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155804
- Sponsor's protocol ID
- FAPESP2010
- Status last verified
- Apr 2010
- First submitted
- 23 Jun 2010
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
PubMed 32378735Miquelutti MA, Cecatti JG, Makuch MY. Developing strategies to be added to the protocol for antenatal care: an exercise and birth preparation program. Clinics (Sao Paulo). 2015 Apr;70(4):231-6. doi: 10.6061/clinics/2015(04)02.
PubMed 26017787Miquelutti MA, Cecatti JG, Makuch MY. Antenatal education and the birthing experience of Brazilian women: a qualitative study. BMC Pregnancy Childbirth. 2013 Sep 5;13:171. doi: 10.1186/1471-2393-13-171.
PubMed 24007540Miquelutti MA, Cecatti JG, Makuch MY. Evaluation of a birth preparation program on lumbopelvic pain, urinary incontinence, anxiety and exercise: a randomized controlled trial. BMC Pregnancy Childbirth. 2013 Jul 29;13:154. doi: 10.1186/1471-2393-13-154.
PubMed 23895188
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
- ClinicalTrials.gov ID
- NCT01155804
- Acronym / sponsor ID
- FAPESP2010
- Keywords
- preparation of the delivery, lumbago, anxiety, urinary incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Center for Research on Reproductive Health of CampinasUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jun 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 2 Jul 2010 (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.
Introduction: randomized studies on programs implemented during pre-natal care that offer information and physical activities preparing pregnant women for delivery are scarce in the scientific literature. Objective: to evaluate the effectively of the Program for Preparation of Pregnant Women for Delivery on the prevention of physical and psychological difficulties and problems during pregnancy and delivery in nulliparous women participating in the program. Subjects and methods: a randomized clinical single blind trial will be conducted with 192 pregnant nulliparous women allocated to participate or not of the program activities. The women allocated to the study group will participate of physical and educational activities at each pre-natal consultation and will receive orientation on the exercises they will perform at their home. Participants of the non-interventional group will follow the habitual routine care at the service. Participants will be selected among nulliparous low risk pregnant women aged between 16 and 40 years old after the 20th week of gestation. Data analysis: will be performing by intention to treat. For the continues variables the t-Student or Wilcoxon test will be performing; for the categorical variables the tests x² or Fisher, and the risk estimate will be estimated using a Relative Risk with 95% CI. ANOVA will be use for measures between the groups and along time, and correlation tests for anxiety and physical activity with gestational and perinatal variables.
Detailed description
Participants, 192 nulliparous women that receive pre-natal care, allocated according to randomization into two groups: group one in which the women who participate in a program with physical and educational activities and the non-interventional group that will not receive the intervention and will follow a regular pre-natal care at routine of the service. The designation of participants will be performed, after informed consent will be sign, by opening sequentially envelopes previously sealed and numbered that will contain the information, previously generated by a computer system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercice | Other | Behavioral: preparation of the delivery |
| non-exercice | Other | Behavioral: preparation of the delivery |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Pregnant women aged between 16 and 40 years old
- gestational age >20 weeks
- nulliparous women
- single fetus
- Performing pre-natal care.
Key exclusion criteria (16 listed)
- Pathological heart condition
- diabetes
- hypertension
- asthma bronchial
- HIV+
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 |
|---|---|---|
| preparation of the deliveryPregnant nulliparous women allocated to the non-interventional group will follow the routine pre-natal care. The participants of the study group will receive routine attention at the pre-natal care service and will also participate in the program of physical and educational after each routine pre-natal consultation. These activities will be organize as follow: 30 minutes of physical exercise for the prevention of pain and discomfort that may occur during pregnancy, preparation of the perineal muscles for delivery and prevention of urinary incontinence, 15 minutes for relaxation and 30 minutes for group discussion to respond to doubts that women may have and issues such as: change in posture during pregnancy and prevention of pain and discomfort; role of the perineal muscles during pregnancy, delivery and puerperium, physiology of delivery, non-pharmacological way for pain relief and breathing control during contractions of labor and delivery. | Behavioural | Exercice, non-exercice |
Primary outcome
To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence
Time frame: The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery
To evaluate a well being in women who were receive intense care during prenatal care by the proportion of women with back pain and those with stress urinary incontinence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
- Derived from this study: PubMed 32378735Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
- Derived from this study: PubMed 26017787Miquelutti MA, Cecatti JG, Makuch MY. Developing strategies to be added to the protocol for antenatal care: an exercise and birth preparation program. Clinics (Sao Paulo). 2015 Apr;70(4):231-6. doi: 10.6061/clinics/2015(04)02.
- Derived from this study: PubMed 24007540Miquelutti MA, Cecatti JG, Makuch MY. Antenatal education and the birthing experience of Brazilian women: a qualitative study. BMC Pregnancy Childbirth. 2013 Sep 5;13:171. doi: 10.1186/1471-2393-13-171.
- Derived from this study: PubMed 23895188Miquelutti MA, Cecatti JG, Makuch MY. Evaluation of a birth preparation program on lumbopelvic pain, urinary incontinence, anxiety and exercise: a randomized controlled trial. BMC Pregnancy Childbirth. 2013 Jul 29;13:154. doi: 10.1186/1471-2393-13-154.
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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.
Centro de Atençao Integral a Saude da Mulher CAISM
Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing preparation of the delivery in people with Lumbago and Anxiety, run by Center for Research on Reproductive Health of Campinas 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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 1 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (time frame: The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery). 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 NCT01155804, which also lists 4 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 1 Jul 2011.