Primary outcomeMean· ten hours
Pain Relief
| Group | Value (millimeters) | Spread |
|---|---|---|
| Control Group | 79.5 | 18.1 |
| Intervention Group | 73.8 | 16.2 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataNon-pharmacological Resources in Assisting Labor
NCTNCT01389128 (opens ClinicalTrials.gov in a new tab)Other idFR443033
This trial does not test a peptide that PepBank tracks.
- Names Oxytocin, does not test it. It appears in the description.
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 80 participants (actual)
- Sponsor
- University of Sao Paulo · Other
- Design
- Randomized · Single masking
- Countries
1 country
Brazil
- Start
- Oct 2011
- Primary completion
- Jul 2012
- Completion
- Jul 2012
- First posted
- 7 Jul 2011 (estimated)
- Last update posted
- 19 Jul 2019
- Conditions
- Labour Pain
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201120122013
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The proposed project will be conducted to evaluate the influence of application resources associated with non-pharmacological during labor for pain relief and accelerated phase of expansion. Although mothers' access to resources for non-pharmacological pain relief during labor is recommended, is not seen as the application of routine obstetric practice, although it has been demonstrated benefits and scientific evidence with your application. It is believed that the implementation of associated application of non-pharmacological resources in assisting the labor can be introduced into daily practice in various hospitals in the country, minimizing pain and favoring the shorter duration of labor, decrease in use of painkillers and inductors, resulting in a reduction of complications, improves the comfort of the mother making her birth experience more satisfying and rewarding, being assisted with security and trained by multidisciplinary teams.
Interventions
- Non-pharmacological resourcesOther
- Routine careOther
Arms2
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.
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Pain Relief
Time frame · ten hours
Registry description
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: * Phase I: 4-5cm of cervical dilation (pelvic mobility in exercise ball) * Phase II: 5-6cm of cervical dilation (lumbosacral massage) * Phase III: 7cm or higher cervical dilation (warm shower)
Secondary outcomes(6)
Evolution of Labor
Time frame · 10 hours
Registry description
Amount of minutes, from admission to labor.
Moment That Women Requested Analgesia During the Active Phase of Labor
Time frame · 10 hours
Registry description
Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief. Data obtained from medical record
Number of Women Who Received Pharmacological Analgesia
Time frame · 10 hours
Registry description
Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself.
Type of Delivery
Time frame · 10 hours
Registry description
Type of delivery at the end of the active phase of labor.
Number of Participants Whose Neonates Had:
Time frame · 10 hours
Registry description
Number and type of neonatal complications as reported in medical chart
Number of Participants With:
Time frame · 10 hours
Registry description
Number and type of maternal complications as reported in medical chart
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeMean· 10 hours
Evolution of Labor
| Group | Value (minutes) | Spread |
|---|---|---|
| Control Group | 492 | 35 |
| Intervention Group | 382 | 24 |
Secondary outcomeMean· 10 hours
Moment That Women Requested Analgesia During the Active Phase of Labor
| Group | Value (centimeter) | Spread |
|---|---|---|
| Control Group | 6 | 1 |
| Intervention Group | 8 | 0.8 |
Secondary outcomeCount of participants· 10 hours
Number of Women Who Received Pharmacological Analgesia
| Group | Value (Participants) |
|---|---|
| Control Group | 37 |
| Intervention Group | 34 |
Secondary outcomeCount of participants· 10 hours
Type of Delivery
| Group | Value (Participants) |
|---|---|
| Control Group | 30 |
| Intervention Group | 35 |
Secondary outcomeCount of participants· 10 hours
Number of Participants Whose Neonates Had:
| Group | Value (Participants) |
|---|---|
| Control Group | 1 |
| Intervention Group | 0 |
Secondary outcomeCount of participants· 10 hours
Number of Participants With:
| Group | Value (Participants) |
|---|---|
| Control Group | 3 |
| Intervention Group | 2 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Control GroupControl Group (CG): 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. Control Group: Routine care of the institution performed by the staff, without the presence of the researcher | – | 0 / 40 | 7 / 40 |
| Intervention GroupIntervention Group (IG): Pregnant women who receive the application the combination of non-pharmacological resources: standing upright pelvic mobility in the ball (4 to 5 cm), alternating stance associated with lumbosacral massage (5 and 6 cm) and shower (\>or= 7 cm); Intervention Group: application of the combination of non-pharmacological resources: standing upright pelvic mobility in the ball, alternating stance associated with lumbosacral massage and shower; | – | 0 / 40 | 0 / 40 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedGallo 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. PMID 29289579
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 15 Years up to 40 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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
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