N/A
N=80
The Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Labor
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01601860 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Number of Participants Who Requested Analgesia During the Active Phase of Childbirth — 37; 35 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Use of non-pharmacological (Other); Other: Routine care (Other)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- University of Sao Paulo
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Requested Analgesia During the Active Phase of Childbirth |
37; 35 | — |
| PRIMARY The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation. |
19; 1; 16; 8; 2; 26 | — |
| PRIMARY Average Duration of the Expulsive Period When Compared to Groups |
26; 18.5 | — |
| PRIMARY Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups |
24; 17; 6; 3; 4; 6 | — |
| PRIMARY Admission Numbers to a Neonatal Intensive Care Unit Between Groups. |
34; 26 | — |
| PRIMARY Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7. |
31; 30; 40; 40 | — |
| PRIMARY Frequency of Suspected Fetal Distress, Between Groups |
2; 1 | — |
| SECONDARY Moment of Rupture of the Chorioamniorex Between the Groups. |
7; 8 | — |
| SECONDARY Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery). |
10; 6; 3; 8; 4; 1 | — |
| SECONDARY Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups. |
2; 0 | — |
| SECONDARY The Number of Puerperal Infections Between Groups. |
0; 0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01601860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.