- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01601860
The Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Labor
Evaluation of Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Parturients in Active Phase of Labor
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
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São Paulo
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Ribeirão Preto, São Paulo, Brasilien
- Professor, Department of Gynecology and Obstetrics, Faculty of Medicine of Ribeirão Preto, University of São Paulo.
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: 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.
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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.
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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);
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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:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Participants Who Requested Analgesia During the Active Phase of Childbirth
Zeitfenster: 10 hours
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Average uterine cervical dilation of the patient who requested analgesia for pain relief.
Data captured from the medical record by the partograph.
|
10 hours
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The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.
Zeitfenster: 10 hours
|
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 |
10 hours
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Average Duration of the Expulsive Period When Compared to Groups
Zeitfenster: Starts with 10 centimeters of dilation until delivery
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Assess the duration of the expulsion period and compare between groups
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Starts with 10 centimeters of dilation until delivery
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Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups
Zeitfenster: 10 hours
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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). |
10 hours
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Admission Numbers to a Neonatal Intensive Care Unit Between Groups.
Zeitfenster: 10 hours
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Consider and compare neonatal admission to an intensive care unit between groups, attracted by the partogram
|
10 hours
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Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7.
Zeitfenster: 10 hours
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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. |
10 hours
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Frequency of Suspected Fetal Distress, Between Groups
Zeitfenster: 10 hours
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Evaluate the frequency of suspected fetal distress with the presence of meconium release.
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10 hours
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Moment of Rupture of the Chorioamniorex Between the Groups.
Zeitfenster: 10 hours
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Observe if the groups had different types of cervical obstetric dilatation when a chorioamniorexis occurred.
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10 hours
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Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).
Zeitfenster: 10 hours
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Type of delivery (cesarean section, normal delivery with laceration, episiotomy, forceps and normal delivery), collected by the partograph found in the medical record.
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10 hours
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Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups.
Zeitfenster: immediately postpartum up to 2 days after childbirth
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Evaluate and compare the presence of hemorrhage with hemodynamic repercussions between groups (requiring surgical approach and / or blood transfusion)
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immediately postpartum up to 2 days after childbirth
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The Number of Puerperal Infections Between Groups.
Zeitfenster: immediately postpartum up to 2 days after childbirth
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Analyze and compare between the groups the number of puerperal infection
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immediately postpartum up to 2 days after childbirth
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Alessandra C Marcolin, Professor, Faculty of Medicine of São Paulo University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- FR444841
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