- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01389128
Non-pharmacological Resources in Assisting Labor
Application of Non-pharmacological Resources in Assisting Labor: Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
Ribeirão Preto, São Paulo, Brazil
- Referral Center Women's Health - Mater
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:- Agreed to participate in the study after reading and signing the consent form;
- Primigravida;
- Pregnancy only;
- Gestational age ≥ 37 weeks;
- Presentation fetal head
- Chorioamniotic intact membranes
- Working with spontaneous onset of labor
- Admission at the beginning of active phase dilation (4-5 cm)
- Lack of maternal and fetal pathologies
- Literacy - primary education
- Absence of cognitive problems
Exclusion Criteria:
- Pregnant women admitted for induction of labor
- Rupture premature or early of chorioamniotic membranes
- Use of uterotonic drugs before the active phase
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Experimental: Intervention Group
Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: pelvic mobility , lumbosacral massage and warm shower.
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A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Relief
Time Frame: ten hours
|
The Visual Analogue Scale - VAS - was used to measure the intensity of the pain described by the patients during the study. The patient was requested do mark a dot in a straight line, measuring 100mm, being a 0 (Zero) no pain and 100 the most intense pain. The researcher then would measure the estimated pain intensity in millimeters. The pain intensity was measured in all three phases before and after each procedure assigned to each group. The phases and their respective procedures were:
|
ten hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evolution of Labor
Time Frame: 10 hours
|
Amount of minutes, from admission to labor.
|
10 hours
|
Moment That Women Requested Analgesia During the Active Phase of Labor
Time Frame: 10 hours
|
Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief.
Data obtained from medical record
|
10 hours
|
Number of Women Who Received Pharmacological Analgesia
Time Frame: 10 hours
|
Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself.
|
10 hours
|
Type of Delivery
Time Frame: 10 hours
|
Type of delivery at the end of the active phase of labor.
|
10 hours
|
Number of Participants Whose Neonates Had:
Time Frame: 10 hours
|
Number and type of neonatal complications as reported in medical chart
|
10 hours
|
Number of Participants With:
Time Frame: 10 hours
|
Number and type of maternal complications as reported in medical chart
|
10 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Silvana M Quintana, professor, Faculty of Medicine of São Paulo University
Publications and helpful links
General Publications
- Huntley AL, Coon JT, Ernst E. Complementary and alternative medicine for labor pain: a systematic review. Am J Obstet Gynecol. 2004 Jul;191(1):36-44. doi: 10.1016/j.ajog.2003.12.008.
- Gallo RBS, Santana LS, Marcolin AC, Duarte G, Quintana SM. Sequential application of non-pharmacological interventions reduces the severity of labour pain, delays use of pharmacological analgesia, and improves some obstetric outcomes: a randomised trial. J Physiother. 2018 Jan;64(1):33-40. doi: 10.1016/j.jphys.2017.11.014. Epub 2017 Dec 27.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FR443033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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