PainNCT01601860
The Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Labor
A study testing Use of non-pharmacological and Other: Routine care in people with Pain, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Although there are studies that investigated the use of non-pharmacological pain relief and correction of dystocia during labor, there are few randomized controlled trials, especially related to combined protocols that use such resources. Read more about this study
- Who is it for?
- Ages 15 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Use of non-pharmacological and Other: Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- May 2012to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Agreement of the patient to participate in the study after reading and signing the consent form;
- primigravida;
- Pregnancy unique;
- Gestational age> 37 weeks;
- fetal cephalic presentation;
- chorioamniotic intact membranes;
Show all 12Show fewer
- spontaneous labor;
- Admission to the beginning of the active phase of dilatation (4 cm cervical dilatation);
- Dynamics between 2 and 4 uterine contractions in ten minutes;
- Lack of maternal and fetal pathologies;
- literate;
- Absence of cognitive problems.
Who cannot join
- Intolerance to non-pharmacological application of resources;
- Increased pain by the woman that prevents the completion of the intervention;
- Want to stop the intervention;
- Suspected acute suffering;
- Indication of cesarean section.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Professor, Department of Gynecology and Obstetrics, Faculty of Medicine of Ribeirão Preto, University of São Paulo.
Ribeirão Preto, São Paulo
About this study
Official title: Evaluation of Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Parturients in Active Phase of Labor
Although there are studies that investigated the use of non-pharmacological pain relief and correction of dystocia during labor, there are few randomized controlled trials, especially related to combined protocols that use such resources. The use of combined protocols could potentiate the effects of resource use alone, evidencing the need for more studies related to the topic, as well as the effects of these methods on maternal and perinatal outcomes. In order to verify the effect of these methods in various stages of labor, childbirth and immediately becomes necessary to conduct a randomized controlled trial well-designed and adequate sample size that can make the future systematic reviews that can definitely conclude about the potential effectiveness of protocols that use combined resources to non-pharmacological pain relief in labor. Aim of our study is to evaluate the effects of a protocol of non-pharmacological resources on pain of pregnant women in the active phase of cervical dilatation and compared with controls.
Read the detailed description
Labor is a natural physiologic process triggered by mechanical and hormonal events that promote uterine contractions. Several non-pharmacological resources can be used during labor, such as relaxation techniques and ongoing support, maternal mobility, walking, breathing exercises, massage, Swiss ball, stool, shower, whirlpool and application of transcutaneous electrical stimulation (ENT .) Despite the role of physiotherapy in labor is not an established practice in public hospitals, it is expected that with the evidence of the benefits of non-pharmacological resources at this time, managers and health professionals validate the importance of interdisciplinary care in pregnancy - postpartum. The aim of this study is to evaluate the effects of resources on non-pharmacological pain of mothers in the active phase of cervical dilatation when compared to controls. This research is a randomized, controlled clinical study that includes pregnant women randomly assigned to two groups: Intervention Group (IG) women who will use the following sequence features: ambulation (with cervical dilatation of 4 to 5 cm), alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) and a shower (with dilation> 7 cm) for 40 minutes each resource; Control Group (CG) women who will not use any physical therapy resource, are subject only to routine procedures of maternity care . For pain assessment will use the Visual Analogue Scale - VAS and the body diagram of the location and spatial distribution of pain. Results are presented in tables and graphs made to better understand the comparisons between the control and intervention. To compare maternal morbidity, obstetric and neonatal between groups will be used Fisher's exact test or chi-square.
- Conditions
- Pain
- Being tested
- Use of non-pharmacological, Other: Routine care
- Keywords
- Labor, vaginal delivery, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of non-pharmacologicalOther
Other: Non-pharmacological resources
A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:
- Walking (with cervical dilation between 4 and 5 cm)
- Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm)
- Shower (with dilation> 7 cm);
Other: Routine careOther
Other: Routine care Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Active Comparator: Control Group Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group. Receives: Other: Other: Routine care |
| Intervention Group | Experimental | Experimental: Intervention Group Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: Walking (with cervical dilation between 4 and 5 cm) Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) Shower (with dilation> 7 cm); Receives: Other: Use of non-pharmacological |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Requested Analgesia During the Active Phase of Childbirth
Average uterine cervical dilation of the patient who requested analgesia for pain relief. Data captured from the medical record by the partograph.
Measured: 10 hours
The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.
Moment when a patient requested analgesia for pain relief. Data captured from the medical record by the partograph.
A partogram was used, which is a printed document and allows the registration of all procedures and complications that occurred during labor, showing the conditions of the parturient and the fetus during this phase. This information is noted on a graph that makes it possible to assess all labor and duration. The doctor filled out the partograph and assessed the patient during labor, and she did not know which group belonged to the patient
Measured: 10 hours
Average Duration of the Expulsive Period When Compared to Groups
Assess the duration of the expulsion period and compare between groups
Measured: Starts with 10 centimeters of dilation until delivery
Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups
Analyze and compare between the groups the types of dystocia.
Dystocia:
b.1) Functional dystocia was considered when cervical dilation increased progressively, but with a speed less than 1 centimeter per hour; b.2) Secondary stop of the dilation was considered when there were 2 vaginal touches with the same cervical dilation in an interval of at least two hours, without being total.
b.3) Secondary descent stop was considered when, with complete dilation of the uterine cervix, the same height of fetal descent was found in two successive touches with an interval of one hour (Protocol Royal College of Obstetricians and Gynecologists, 2012).
Measured: 10 hours
Admission Numbers to a Neonatal Intensive Care Unit Between Groups.
Consider and compare neonatal admission to an intensive care unit between groups, attracted by the partogram
Measured: 10 hours
Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7.
Analyze and compare Apgar scores of the 1-min >7 and 5-min >7, between groups. The APGAR score reflects the degree of fetal maturity and predicts healthy child development. It is a scale that can vary from 0 to 10, which 0 is a bad vitality and 10 is an excellent score. When the APGAR score is below 7, especially in the fifth minute, it is a warning sign to give special attention to the newborn.
Newborns who have an Apgar in the first minute greater than 7, demonstrate good birth conditions.
Measured: 10 hours
Frequency of Suspected Fetal Distress, Between Groups
Evaluate the frequency of suspected fetal distress with the presence of meconium release.
Measured: 10 hours
Secondary outcomes (4)
Moment of Rupture of the Chorioamniorex Between the Groups.
Observe if the groups had different types of cervical obstetric dilatation when a chorioamniorexis occurred.
Measured: 10 hours
Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).
Type of delivery (cesarean section, normal delivery with laceration, episiotomy, forceps and normal delivery), collected by the partograph found in the medical record.
Measured: 10 hours
Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups.
Evaluate and compare the presence of hemorrhage with hemodynamic repercussions between groups (requiring surgical approach and / or blood transfusion)
Measured: immediately postpartum up to 2 days after childbirth
The Number of Puerperal Infections Between Groups.
Analyze and compare between the groups the number of puerperal infection
Measured: immediately postpartum up to 2 days after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Cristina Marcolin, University of Sao Paulo
- Investigators
- Alessandra C Marcolin, Professor, Principal investigator, Faculty of Medicine of São Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601860
- Sponsor's protocol ID
- FR444841
- Status last verified
- May 2021
- First submitted
- 19 Sep 2011
- Last updated
- 9 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Frenea S, Chirossel C, Rodriguez R, Baguet JP, Racinet C, Payen JF. The effects of prolonged ambulation on labor with epidural analgesia. Anesth Analg. 2004 Jan;98(1):224-229. doi: 10.1213/01.ANE.0000090317.01876.D9.
PubMed 14693624
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Parturients in Active Phase of Labor
- ClinicalTrials.gov ID
- NCT01601860
- Acronym / sponsor ID
- FR444841
- Conditions
- Pain
- Keywords
- Labor, vaginal delivery, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Posted 17 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although there are studies that investigated the use of non-pharmacological pain relief and correction of dystocia during labor, there are few randomized controlled trials, especially related to combined protocols that use such resources. The use of combined protocols could potentiate the effects of resource use alone, evidencing the need for more studies related to the topic, as well as the effects of these methods on maternal and perinatal outcomes. In order to verify the effect of these methods in various stages of labor, childbirth and immediately becomes necessary to conduct a randomized controlled trial well-designed and adequate sample size that can make the future systematic reviews that can definitely conclude about the potential effectiveness of protocols that use combined resources to non-pharmacological pain relief in labor. Aim of our study is to evaluate the effects of a protocol of non-pharmacological resources on pain of pregnant women in the active phase of cervical dilatation and compared with controls.
Detailed description
Labor is a natural physiologic process triggered by mechanical and hormonal events that promote uterine contractions. Several non-pharmacological resources can be used during labor, such as relaxation techniques and ongoing support, maternal mobility, walking, breathing exercises, massage, Swiss ball, stool, shower, whirlpool and application of transcutaneous electrical stimulation (ENT .) Despite the role of physiotherapy in labor is not an established practice in public hospitals, it is expected that with the evidence of the benefits of non-pharmacological resources at this time, managers and health professionals validate the importance of interdisciplinary care in pregnancy - postpartum. The aim of this study is to evaluate the effects of resources on non-pharmacological pain of mothers in the active phase of cervical dilatation when compared to controls. This research is a randomized, controlled clinical study that includes pregnant women randomly assigned to two groups: Intervention Group (IG) women who will use the following sequence features: ambulation (with cervical dilatation of 4 to 5 cm), alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) and a shower (with dilation> 7 cm) for 40 minutes each resource; Control Group (CG) women who will not use any physical therapy resource, are subject only to routine procedures of maternity care . For pain assessment will use the Visual Analogue Scale - VAS and the body diagram of the location and spatial distribution of pain. Results are presented in tables and graphs made to better understand the comparisons between the control and intervention. To compare maternal morbidity, obstetric and neonatal between groups will be used Fisher's exact test or chi-square.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Other: Routine careActive Comparator: Control Group Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group. |
| Intervention Group | Experimental | Other: Use of non-pharmacologicalExperimental: Intervention Group Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: Walking (with cervical dilation between 4 and 5 cm) Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) Shower (with dilation> 7 cm); |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Agreement of the patient to participate in the study after reading and signing the consent form;
Key exclusion criteria (5 listed)
- Intolerance to non-pharmacological application of resources;
- Increased pain by the woman that prevents the completion of the intervention;
- Want to stop the intervention;
- Suspected acute suffering;
- Indication of cesarean section.
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 |
|---|---|---|
| Use of non-pharmacologicalOther: Non-pharmacological resources A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows: * Walking (with cervical dilation between 4 and 5 cm) * Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) * Shower (with dilation> 7 cm); | Other | Intervention Group |
| Other: Routine careOther: Routine care Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient. | Other | Control |
Primary outcome
Number of Participants Who Requested Analgesia During the Active Phase of Childbirth
Time frame: 10 hours
Average uterine cervical dilation of the patient who requested analgesia for pain relief. Data captured from the medical record by the partograph.
The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.
Time frame: 10 hours
Moment when a patient requested analgesia for pain relief. Data captured from the medical record by the partograph. A partogram was used, which is a printed document and allows the registration of all procedures and complications that occurred during labor, showing the conditions of the parturient and the fetus during this phase. This information is noted on a graph that makes it possible to assess all labor and duration. The doctor filled out the partograph and assessed the patient during labor, and she did not know which group belonged to the patient
Average Duration of the Expulsive Period When Compared to Groups
Time frame: Starts with 10 centimeters of dilation until delivery
Assess the duration of the expulsion period and compare between groups
Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups
Time frame: 10 hours
Analyze and compare between the groups the types of dystocia. Dystocia: b.1) Functional dystocia was considered when cervical dilation increased progressively, but with a speed less than 1 centimeter per hour; b.2) Secondary stop of the dilation was considered when there were 2 vaginal touches with the same cervical dilation in an interval of at least two hours, without being total. b.3) Secondary descent stop was considered when, with complete dilation of the uterine cervix, the same height of fetal descent was found in two successive touches with an interval of one hour (Protocol Royal College of Obstetricians and Gynecologists, 2012).
Admission Numbers to a Neonatal Intensive Care Unit Between Groups.
Time frame: 10 hours
Consider and compare neonatal admission to an intensive care unit between groups, attracted by the partogram
Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7.
Time frame: 10 hours
Analyze and compare Apgar scores of the 1-min >7 and 5-min >7, between groups. The APGAR score reflects the degree of fetal maturity and predicts healthy child development. It is a scale that can vary from 0 to 10, which 0 is a bad vitality and 10 is an excellent score. When the APGAR score is below 7, especially in the fifth minute, it is a warning sign to give special attention to the newborn. Newborns who have an Apgar in the first minute greater than 7, demonstrate good birth conditions.
Frequency of Suspected Fetal Distress, Between Groups
Time frame: 10 hours
Evaluate the frequency of suspected fetal distress with the presence of meconium release.
4 secondary outcomes
Moment of Rupture of the Chorioamniorex Between the Groups.
Time frame: 10 hours
Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).
Time frame: 10 hours
Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups.
Time frame: immediately postpartum up to 2 days after childbirth
The Number of Puerperal Infections Between Groups.
Time frame: immediately postpartum up to 2 days after childbirth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14693624Frenea S, Chirossel C, Rodriguez R, Baguet JP, Racinet C, Payen JF. The effects of prolonged ambulation on labor with epidural analgesia. Anesth Analg. 2004 Jan;98(1):224-229. doi: 10.1213/01.ANE.0000090317.01876.D9.
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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.
Alessandra C Marcolin, Professor principal investigator
Faculty of Medicine of São Paulo 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 Use of non-pharmacological and Other: Routine care in people with Pain, run by University of Sao Paulo 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 12 inclusion and 5 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 9 Jun 2021. 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?
Yes. Results are posted in the registry (first posted 17 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Requested Analgesia During the Active Phase of Childbirth (time frame: 10 hours). The study lists 7 primary outcomes in all. 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 NCT01601860, which also lists 1 linked publication.
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 9 Jun 2021.