Effectiveness of Warm Packs, Perineal Massage and Hands Off During Labour in the Perineal Outcomes.

Study Overview
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Brief Summary
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This study evaluates the effectiveness of warm packs, perineal massage and hands off, during labour, in the perineal outcomes. The perineal outcomes are perineal tears, grade of perineal tears, need of suture, perineal edema, perineal pain, use of drugs for perineal pain, and satisfaction with the technique used.

Detailed Description
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This study is a randomised controled trial.

Official Title
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Effectiveness of Warm Packs, Perineal Massage and Hands Off During Labour in the Perineal Outcomes.

Conditions
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Perineal Tear

Intervention / Treatment
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* Procedure: Warm packs
* Procedure: Perineal massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: parturient in active phase of labour single fetus at term (37-42 weeks) bent cephalic fetal presentation parity less than four children Exclusion Criteria: use any perineal preparation techniques during pregnancy clinical indication for caesarean section
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warm packs<br>The warm packs are held in the mother's perineum during birth. The warm packs are changed as needed to maintain warmth. | Procedure: Warm packs<br>* : The warm packs are held in the mother's perineum during birth. The warm packs are changed as needed to maintain warmth.<br>|
| Experimental: Perineal massage<br>The perineal massage will be gently held in the longitudinal direction of the muscle fibers, with movements of the thumb and forefinger, like count coins. | Procedure: Perineal massage<br>* The perineal massage will be gently held in the longitudinal direction of the muscle fibers, with movements of the thumb and forefinger, like count coins.<br>|
| No Intervention: Hands off<br>Hands off group does not receive any perineal manipulation and they are only observed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of suture | Number of participants with perineal tear after vaginal delivery requiring suture (evaluated as yes or no). | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of perineal tear | Perineal tear ranked 1st, 2nd, 3rd and 4th degree | 30 minutes | 
| perineal edema | Perineal edema is scored 0-4 (0 = no edema; 4 = edema invades the perineal body) . | 1 hour | 
| Perineal pain | self reported ´perineal pain intensity. Perineal pain is scored 0-10 (0 = no pain; 10 = pain as bad as can be). | 24 hours | 
| Use of drugs for perineal pain | Number of participants using drugs for perineal pain at the time of 24 hours after vaginal delivery (evaluated as yes or no). | 24 hours | 
| Satisfaction with the technique used | Satisfaction of the woman with the technique used for perineal care. Satisfaction is scored 0-4 (0 = very satisfied; 4 = very dissatisfied) | 24 hours | 
| Perineal tear | Number of participants with perineal tear after vaginal delivery (evaluated as yes or no). | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perineal tear, pain, pelvic floor, Labour