Postpartum PeriodNCT01020240
Physiotherapy in Postpartum After a Cesarean
A study testing Avolition, Orientation and Guide in people with Postpartum Period, run by Sao Marcos University at 1 site in Brazil.
Trial summary
The purpose of this study is to promote a prevention of the complications using an elaborate guide effective and easy to understand. Read more about this study
- Who is it for?
- Ages 15 to 35 years, women only
- Conditions the study is for
- Postpartum Period
- What is being tested?
- Avolition, Orientation and Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Jun 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 15 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- have between 15 and 35 yeas old
- has realize an emergency or elective cesarean
- being in immediate puerperium and did not have receive any orientation
Who cannot join
- complications in delivery and postpartum
- complications with the baby
- physicologics disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Orientation Guide for Puerperal Women After Cesarean.
The purpose of this study is to promote a prevention of the complications using an elaborate guide effective and easy to understand.
Read the detailed description
The puerperium consists the period of pregnancy and postpartum cycle that the alterations provoked for pregnancy and delivery on the women organism return to your state before pregnancy. The physiotherapist can follow the puerperium since hospital phase until women has been recovered of pregnancy physiologist alterations.
- Conditions
- Postpartum Period
- Being tested
- Avolition, Orientation, Guide
- Keywords
- Immediate puerperium, physiotherapy in postpartum, cesarean complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvolitionBehavioural
- avolition for cesarean discomforts
OrientationBehavioural
- avolition of cesarean discomfort
- physiotherapy orientation
GuideBehavioural
- avolition of cesarean discomfort
- physiotherapy orientation
- guide orientation
| Study group | Role | What they receive |
|---|---|---|
| Avaliation | No intervention | This group will have 15 women in puerperium and will be realize an interview to avalide the cesarean discomforts in immediate puerperium. These dates will be use for elaborate the orientations guide. Receives: Behavioral: Avolition |
| Orientation | No intervention | In this group will be realize an interview to avalide the cesarean discomforts in immediate puerperium or in the first post operatory and in the second post operatory wil be realize a new interview. Receives: Behavioral: Orientation |
| Guide | Experimental | in This group wiil be realize an interview to avalide the cesarean discomforts in immediate puerperium or in the first post operatory, will be realize the orientations and the guide will be give, and in the second post operatory will be realize a new interview. Receives: Behavioral: Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analogic Visual Scale
Measured: 6 months
Secondary outcomes (1)
Analogic Visual Scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum PeriodStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sao Marcos University
- Sponsor type
- University, hospital or other
- Investigators
- Patricia Batista, Principal investigator, São Marcos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020240
- Sponsor's protocol ID
- Unimarco
- Status last verified
- Nov 2009
- First submitted
- 24 Nov 2009
- Last updated
- 26 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Orientation Guide for Puerperal Women After Cesarean.
- ClinicalTrials.gov ID
- NCT01020240
- Acronym / sponsor ID
- Unimarco
- Conditions
- Postpartum Period
- Keywords
- Immediate puerperium, physiotherapy in postpartum, cesarean complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sao Marcos UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Nov 2009 (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.
The purpose of this study is to promote a prevention of the complications using an elaborate guide effective and easy to understand.
Detailed description
The puerperium consists the period of pregnancy and postpartum cycle that the alterations provoked for pregnancy and delivery on the women organism return to your state before pregnancy. The physiotherapist can follow the puerperium since hospital phase until women has been recovered of pregnancy physiologist alterations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Avaliation | No intervention | Behavioral: AvolitionThis group will have 15 women in puerperium and will be realize an interview to avalide the cesarean discomforts in immediate puerperium. These dates will be use for elaborate the orientations guide. |
| Orientation | No intervention | Behavioral: OrientationIn this group will be realize an interview to avalide the cesarean discomforts in immediate puerperium or in the first post operatory and in the second post operatory wil be realize a new interview. |
| Guide | Experimental | Behavioral: Guidein This group wiil be realize an interview to avalide the cesarean discomforts in immediate puerperium or in the first post operatory, will be realize the orientations and the guide will be give, and in the second post operatory will be realize a new interview. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- have between 15 and 35 yeas old
- has realize an emergency or elective cesarean
- being in immediate puerperium and did not have receive any orientation
Key exclusion criteria (3 listed)
- complications in delivery and postpartum
- complications with the baby
- physicologics disease
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 |
|---|---|---|
| Avolition- avolition for cesarean discomforts | Behavioural | Avaliation |
| Orientation* avolition of cesarean discomfort * physiotherapy orientation | Behavioural | Orientation |
| Guide* avolition of cesarean discomfort * physiotherapy orientation * guide orientation | Behavioural | Guide |
Primary outcome
Analogic Visual Scale
Time frame: 6 months
1 secondary outcome
Analogic Visual Scale
Time frame: 6 months
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 26 Nov 2009.
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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.
Patricia Batista principal investigator
São Marcos University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avolition, Orientation and Guide in people with Postpartum Period, run by Sao Marcos University 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 3 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 26 Nov 2009. 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?
Analogic Visual Scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2009.