Primary outcomeCount of participants· 10 hours
Number of Participants Who Requested Analgesia During the Active Phase of Childbirth
| Group | Value (Participants) |
|---|---|
| Control Group | 37 |
| Intervention Group | 35 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataThe Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Labor
NCTNCT01601860 (opens ClinicalTrials.gov in a new tab)Other idFR444841
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
- May 2012
- Primary completion
- Jan 2016
- Completion
- Jan 2016
- First posted
- 18 May 2012 (estimated)
- Last update posted
- 9 Jun 2021
- Conditions
- Pain
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201220132014201520162017
- N/A
The Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Labor
NCT01601860May 2012 to Jan 2016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Use of non-pharmacologicalOther
- Other: Routine careOther
Arms2
Active comparator
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.
Experimental
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);
Primary outcomes7
Outcomes the sponsor listed as primary.
Number of Participants Who Requested Analgesia During the Active Phase of Childbirth
Time frame · 10 hours
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
Evaluate the frequency of suspected fetal distress with the presence of meconium release.
Secondary outcomes(4)
Moment of Rupture of the Chorioamniorex Between the Groups.
Time frame · 10 hours
Registry description
Observe if the groups had different types of cervical obstetric dilatation when a chorioamniorexis occurred.
Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).
Time frame · 10 hours
Registry description
Type of delivery (cesarean section, normal delivery with laceration, episiotomy, forceps and normal delivery), collected by the partograph found in the medical record.
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
Registry description
Evaluate and compare the presence of hemorrhage with hemodynamic repercussions between groups (requiring surgical approach and / or blood transfusion)
The Number of Puerperal Infections Between Groups.
Time frame · immediately postpartum up to 2 days after childbirth
Registry description
Analyze and compare between the groups the number of puerperal infection
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeCount of participants· 10 hours
The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.
| Group | Value (Participants) |
|---|---|
| Control | 19 |
| Intervention Group | 1 |
Primary outcomeMean· Starts with 10 centimeters of dilation until delivery
Average Duration of the Expulsive Period When Compared to Groups
| Group | Value (minutes) |
|---|---|
| Control Group | 26 |
| Intervention Group | 18.5 |
Primary outcomeCount of participants· 10 hours
Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups
| Group | Value (Participants) |
|---|---|
| Control Group | 24 |
| Intervention Group | 17 |
Primary outcomeCount of participants· 10 hours
Admission Numbers to a Neonatal Intensive Care Unit Between Groups.
| Group | Value (Participants) |
|---|---|
| Control Group | 34 |
| Intervention Group | 26 |
Primary outcomeCount of participants· 10 hours
Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7.
| Group | Value (Participants) |
|---|---|
| Control Group | 31 |
| Intervention Group | 30 |
Primary outcomeCount of participants· 10 hours
Frequency of Suspected Fetal Distress, Between Groups
| Group | Value (Participants) |
|---|---|
| Control Group | 2 |
| Intervention Group | 1 |
Secondary and other outcome results(1)
Secondary outcomeMedian· 10 hours
Moment of Rupture of the Chorioamniorex Between the Groups.
| Group | Value (centimeters) |
|---|---|
| Control Group | 7 |
| Intervention Group | 8 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Intervention GroupExperimental: 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); | – | 0 / 40 | 0 / 40 |
| ControlActive 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. | – | 0 / 40 | 2 / 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
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Randomized controlled trial · 2004
The effects of prolonged ambulation on labor with epidural analgesia.
Frenea et al. 2004Anesthesia and analgesiacited by 21
PMID 14693624DOI 10.1213/01.ane.0000090317.01876.d9PUB-14693624
Rights unknown
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 15 Years up to 30 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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;
* 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.
Exclusion Criteria:
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.
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