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The purpose of this study is to evaluate whether perineal massage during labor can help prevent perineal trauma, such as lacerations or episiotomies.
The study will test two hypotheses:
Null hypothesis: Perineal massage during labor does not prevent perineal trauma.
Alternative hypothesis: Perineal massage during labor helps prevent perineal trauma.
Participants will be randomly assigned to one of two groups:
Perineal massage group: Participants will receive perineal massage during labor.
Control group: Participants will receive the standard care provided by the labor and delivery unit.
A randomization process will be used to assign participants to each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perineal Massage Group | Experimental | The perineal massage group will receive the intervention during labor. |
|
| Control Group | No Intervention | The control group will receive the standard care provided by the obstetric center. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perineal massage | Procedure | Perineal massage will be performed during labor, either between or during contractions, regardless of the position chosen by the laboring woman. The researcher, wearing gloves, will insert one or two fingers (index and middle) into the participant's vaginal canal and move them from side to side in a "U"-shaped motion, for approximately one second in each direction. Light downward pressure will be applied toward the rectum, according to the woman's tolerance, until relaxation of the massaged perineal muscles is observed. A water-based lubricant will be used to facilitate the procedure. The massage will last no longer than 5 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of perineal trauma (laceration or episiotomy) during vaginal delivery | The presence and degree of perineal trauma will be assessed after delivery by the attending healthcare provider. Trauma will be classified by the presence of spontaneous perineal lacerations (graded I to IV) and/or performance of episiotomy. | At the time of delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Plentz Stein | Contact | +55 51997710248 | gabrielaplentz.fisio@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2024 | Jul 25, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 2, 2024 | Jul 25, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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