Trial Outcomes & Findings for Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor (NCT NCT01600495)
NCT ID: NCT01600495
Last Updated: 2015-10-05
Results Overview
To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale. Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled "no pain" associated with a score of 0 mm and at the other end "worst pain imagined" with a score 100 mm)
COMPLETED
PHASE4
46 participants
30 minutes
2015-10-05
Participant Flow
A randomized, controlled clinical noninferiority with an evaluator blind, comparative analysis of a study group and a control group, this estdo includes 46 patients, was developed in the Reference Center for Women's Health in Ribeirão Preto, São Paulo state Brazil, during the period September 2011 to February 2012 .
283 women in labor were eligible, women were excluded because they did not participate 237 the inclusion criteria (first pregnancy, the position of a single fetus head, above 37 weeks, 4-5 cm of cervical dilatation, spontaneous onset of labor, not use of medications during the study period, intact membranes, and not associated with risk factors).
Participant milestones
| Measure |
Experimental TENS
TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
|
Control Group
Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor
Baseline characteristics by cohort
| Measure |
Experimental TENS
n=23 Participants
TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
|
Control Group
n=23 Participants
Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
19.8 years
STANDARD_DEVIATION 3.9 • n=99 Participants
|
19.8 years
STANDARD_DEVIATION 3.7 • n=107 Participants
|
19.8 years
STANDARD_DEVIATION 3.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
23 participants
n=99 Participants
|
23 participants
n=107 Participants
|
46 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: We evaluated 46 patients, divided into 23 ENT group and 23 in the control group.
To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale. Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled "no pain" associated with a score of 0 mm and at the other end "worst pain imagined" with a score 100 mm)
Outcome measures
| Measure |
Experimental TENS
n=23 Participants
TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
|
Control Group
n=23 Participants
Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
|
|---|---|---|
|
Classification of Pain During Labor by Visual Analogue Scale
|
57.0 mm
Standard Deviation 23.4
|
72.1 mm
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: 10 hoursPopulation: Analyzing the date of application of pharmacological analgesia.
Consider whether the TENS therapy during the active phase of labor could defer request for analgesia use for pain relief for pregnant women. The cervical dilation indicates the value in centimeters (0-10) of cervical dilation. Assessed on admission and during labor by doctors (according to the routine of the institution), as recorded in medical records.
Outcome measures
| Measure |
Experimental TENS
n=23 Participants
TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
|
Control Group
n=23 Participants
Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
|
|---|---|---|
|
Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia
|
7.0 cm
Standard Deviation 1.72
|
6.41 cm
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: 10 hoursPopulation: Analyzing the duration of labor
The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child.
Outcome measures
| Measure |
Experimental TENS
n=23 Participants
TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
|
Control Group
n=23 Participants
Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
|
|---|---|---|
|
Duration From Start of Labor Until Birth
|
393 min
Standard Deviation 139.4
|
322 min
Standard Deviation 75.6
|
SECONDARY outcome
Timeframe: 10 hoursPopulation: All patients were invited to answer the questionnaire.
Simple questionnaire (Questionnaire satisfaction of parturients with comparision with experience in this study) developed for this study with 3 items (yes, no and do not want to answer) to assess satisfaction of mothers in the intervention group and the control group regarding the presence of a professional during the period of study and experience in this work.
Outcome measures
| Measure |
Experimental TENS
n=23 Participants
TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
|
Control Group
n=23 Participants
Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
|
|---|---|---|
|
Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.
|
17 participants
|
7 participants
|
Adverse Events
Experimental TENS
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Alessandra Cristina Marcolin
University of São Paulo.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place