Trial Outcomes & Findings for The Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Labor (NCT NCT01601860)
NCT ID: NCT01601860
Last Updated: 2021-06-09
Results Overview
Average uterine cervical dilation of the patient who requested analgesia for pain relief. Data captured from the medical record by the partograph.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
10 hours
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
Intervention Group
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);
Use of non-pharmacological: 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);
|
Control
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.
Other: Routine care: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
19
|
31
|
|
Overall Study
NOT COMPLETED
|
21
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low-risk primigravidae women admitted to the maternity ward in the active phase of labor.
Baseline characteristics by cohort
| Measure |
Control
n=40 Participants
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.
Other: Routine care: 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.
|
Intervention Group
n=40 Participants
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);
Use of non-pharmacological: 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);
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
21.8 Years
STANDARD_DEVIATION 4.22 • n=5 Participants
|
22 Years
STANDARD_DEVIATION 4.49 • n=7 Participants
|
21.9 Years
STANDARD_DEVIATION 4.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants • Low-risk primigravidae women admitted to the maternity ward in the active phase of labor.
|
40 Participants
n=7 Participants • Low-risk primigravidae women admitted to the maternity ward in the active phase of labor.
|
80 Participants
n=5 Participants • Low-risk primigravidae women admitted to the maternity ward in the active phase of labor.
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants • Low-risk primigravidae women admitted to the maternity ward in the active phase of labor.
|
0 Participants
n=7 Participants • Low-risk primigravidae women admitted to the maternity ward in the active phase of labor.
|
0 Participants
n=5 Participants • Low-risk primigravidae women admitted to the maternity ward in the active phase of labor.
|
|
BMI
|
28.4 Kilograms per square meter
STANDARD_DEVIATION 5.36 • n=5 Participants
|
28.6 Kilograms per square meter
STANDARD_DEVIATION 4.94 • n=7 Participants
|
28.5 Kilograms per square meter
STANDARD_DEVIATION 5.15 • n=5 Participants
|
|
School degree
Elementary school
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
School degree
Middle school
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
School degree
High school
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Marital status
Single
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Marital status
Married
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Marital status
with partner
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Paid employment,
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
PPW (pre-pregnancy weight)
|
60.5 Kilograms per square meter
STANDARD_DEVIATION 13 • n=5 Participants
|
61.1 Kilograms per square meter
STANDARD_DEVIATION 14.4 • n=7 Participants
|
60.8 Kilograms per square meter
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
PDW (pre-delivery weight)
|
72.6 Kilograms per square meter
STANDARD_DEVIATION 14.7 • n=5 Participants
|
73.6 Kilograms per square meter
STANDARD_DEVIATION 14.4 • n=7 Participants
|
73.1 Kilograms per square meter
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Height
|
1.6 centimeters
STANDARD_DEVIATION 0.07 • n=5 Participants
|
1.6 centimeters
STANDARD_DEVIATION 0.05 • n=7 Participants
|
1.6 centimeters
STANDARD_DEVIATION 0.06 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 hoursPopulation: \[Not Specified\]
Average uterine cervical dilation of the patient who requested analgesia for pain relief. Data captured from the medical record by the partograph.
Outcome measures
| Measure |
Control Group
n=40 Participants
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.
Other: Routine care: 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.
|
Intervention Group
n=40 Participants
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);
Use of non-pharmacological: 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).
|
|---|---|---|
|
Number of Participants Who Requested Analgesia During the Active Phase of Childbirth
|
37 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: 10 hoursPopulation: \[Not Specified\]
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
Outcome measures
| Measure |
Control Group
n=40 Participants
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.
Other: Routine care: 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.
|
Intervention Group
n=40 Participants
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);
Use of non-pharmacological: 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).
|
|---|---|---|
|
The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.
4- 5 cm
|
19 Participants
|
1 Participants
|
|
The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.
6 - 7 cm
|
16 Participants
|
8 Participants
|
|
The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.
> 7 cm
|
2 Participants
|
26 Participants
|
|
The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.
Did not receive analgesia
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Starts with 10 centimeters of dilation until deliveryPopulation: \[Not Specified\]
Assess the duration of the expulsion period and compare between groups
Outcome measures
| Measure |
Control Group
n=40 Participants
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.
Other: Routine care: 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.
|
Intervention Group
n=40 Participants
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);
Use of non-pharmacological: 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).
|
|---|---|---|
|
Average Duration of the Expulsive Period When Compared to Groups
|
26 minutes
Interval 7.0 to 135.0
|
18.5 minutes
Interval 5.0 to 140.0
|
PRIMARY outcome
Timeframe: 10 hoursPopulation: \[Not Specified\]
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).
Outcome measures
| Measure |
Control Group
n=40 Participants
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.
Other: Routine care: 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.
|
Intervention Group
n=40 Participants
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);
Use of non-pharmacological: 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).
|
|---|---|---|
|
Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups
functional
|
24 Participants
|
17 Participants
|
|
Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups
secondary stop of dilation
|
6 Participants
|
3 Participants
|
|
Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups
Secondary descent stop
|
4 Participants
|
6 Participants
|
|
Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups
without dystocia
|
6 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 10 hoursPopulation: \[Not Specified\]
Consider and compare neonatal admission to an intensive care unit between groups, attracted by the partogram
Outcome measures
| Measure |
Control Group
n=40 Participants
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.
Other: Routine care: 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.
|
Intervention Group
n=40 Participants
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);
Use of non-pharmacological: 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).
|
|---|---|---|
|
Admission Numbers to a Neonatal Intensive Care Unit Between Groups.
|
34 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: 10 hoursPopulation: \[Not Specified\]
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.
Outcome measures
| Measure |
Control Group
n=40 Participants
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.
Other: Routine care: 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.
|
Intervention Group
n=40 Participants
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);
Use of non-pharmacological: 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).
|
|---|---|---|
|
Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7.
1-min >7
|
31 Participants
|
30 Participants
|
|
Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7.
5-min >7
|
40 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: 10 hoursPopulation: \[Not Specified\]
Evaluate the frequency of suspected fetal distress with the presence of meconium release.
Outcome measures
| Measure |
Control Group
n=40 Participants
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.
Other: Routine care: 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.
|
Intervention Group
n=40 Participants
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);
Use of non-pharmacological: 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).
|
|---|---|---|
|
Frequency of Suspected Fetal Distress, Between Groups
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 10 hoursPopulation: \[Not Specified\]
Observe if the groups had different types of cervical obstetric dilatation when a chorioamniorexis occurred.
Outcome measures
| Measure |
Control Group
n=40 Participants
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.
Other: Routine care: 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.
|
Intervention Group
n=40 Participants
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);
Use of non-pharmacological: 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).
|
|---|---|---|
|
Moment of Rupture of the Chorioamniorex Between the Groups.
|
7 centimeters
Interval 5.0 to 10.0
|
8 centimeters
Interval 6.0 to 10.0
|
SECONDARY outcome
Timeframe: 10 hoursPopulation: \[Not Specified\]
Type of delivery (cesarean section, normal delivery with laceration, episiotomy, forceps and normal delivery), collected by the partograph found in the medical record.
Outcome measures
| Measure |
Control Group
n=40 Participants
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.
Other: Routine care: 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.
|
Intervention Group
n=40 Participants
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);
Use of non-pharmacological: 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).
|
|---|---|---|
|
Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).
Cesarean section
|
10 Participants
|
6 Participants
|
|
Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).
normal birth
|
3 Participants
|
8 Participants
|
|
Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).
childbirth forcep
|
4 Participants
|
1 Participants
|
|
Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).
delivery with episiotomy
|
17 Participants
|
14 Participants
|
|
Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).
delivery with laceration
|
6 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: immediately postpartum up to 2 days after childbirthPopulation: \[Not Specified\]
Evaluate and compare the presence of hemorrhage with hemodynamic repercussions between groups (requiring surgical approach and / or blood transfusion)
Outcome measures
| Measure |
Control Group
n=40 Participants
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.
Other: Routine care: 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.
|
Intervention Group
n=40 Participants
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);
Use of non-pharmacological: 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).
|
|---|---|---|
|
Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups.
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: immediately postpartum up to 2 days after childbirthPopulation: \[Not Specified\]
Analyze and compare between the groups the number of puerperal infection
Outcome measures
| Measure |
Control Group
n=40 Participants
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.
Other: Routine care: 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.
|
Intervention Group
n=40 Participants
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);
Use of non-pharmacological: 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).
|
|---|---|---|
|
The Number of Puerperal Infections Between Groups.
|
0 Participants
|
0 Participants
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=40 participants at risk
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);
Use of non-pharmacological: 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);
|
Control
n=40 participants at risk
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.
Other: Routine care: 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.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Postpartum complication (Hemorrhage) * [1]
|
0.00%
0/40 • [Not specified]
Postpartum complication (Hemorrhage)
|
5.0%
2/40 • [Not specified]
Postpartum complication (Hemorrhage)
|
Additional Information
Dra. Alessandra Cristina Marcolin
University of São Paulo
Phone: +55(16)36022813
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place