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

Not Applicable

• Conditions: Perineal Tear
• Interventions: Procedure: Warm packs; Procedure: Perineal massage

• Registration Number: NCT02588508
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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

This study is a randomised controled trial.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-18
• Last Update Posted: 2015-11-20
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warm packs	Warm packs	The warm packs are held in the mother's perineum during birth. The warm packs are changed as needed to maintain warmth.
Perineal massage	Perineal massage	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".

Primary Outcome Measures

Name	Time	Method
Need of suture	30 minutes	Number of participants with perineal tear after vaginal delivery requiring suture (evaluated as yes or no).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UFPernambuco; 🇧🇷 Recife, Pernambuco, Brazil