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

• Sponsor: Universidade Federal de Pernambuco (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02588508
• Collaborator: (none)
• Enrollment: 201
• Location: 1
• Arms: 3
• Duration (Months): 9
• Patients Per Site Per Month: 22.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perineal Tear	Procedure: Warm packs; Procedure: Perineal massage	N/A

Detailed Description

This study is a randomised controled trial.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Effectiveness of Warm Packs, Perineal Massage and Hands Off During Labour in the Perineal Outcomes.
• Study Start Date: Apr 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Warm packs 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; : The warm packs are held in the mother's perineum during birth. The warm packs are changed as needed to maintain warmth.
Experimental: 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".	Procedure: 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".
No Intervention: Hands off Hands off group does not receive any perineal manipulation and they are only observed.

Outcome Measures

Primary Outcome Measures

1. Need of suture [30 minutes]

   Number of participants with perineal tear after vaginal delivery requiring suture (evaluated as yes or no).

Secondary Outcome Measures

1. Grade of perineal tear [30 minutes]

   Perineal tear ranked 1st, 2nd, 3rd and 4th degree

2. perineal edema [1 hour]

   Perineal edema is scored 0-4 (0 = no edema; 4 = edema invades the perineal body) .

3. 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).

4. 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).

5. 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)

6. Perineal tear [30 minutes]

   Number of participants with perineal tear after vaginal delivery (evaluated as yes or no).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UFPernambuco	Recife	Pernambuco	Brazil

Sponsors and Collaborators

• Universidade Federal de Pernambuco

Investigators

• Study Director: Caroline WS Ferreira, PHD, Universidade Federal de Pernambuco

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Albers LL, Sedler KD, Bedrick EJ, Teaf D, Peralta P. Factors related to genital tract trauma in normal spontaneous vaginal births. Birth. 2006 Jun;33(2):94-100.
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• Responsible Party: Jânio do Nascimento Alves, Master Student, Universidade Federal de Pernambuco
• ClinicalTrials.gov Identifier: NCT02588508
• Other Study ID Numbers: 0335932
• First Posted: Oct 27, 2015
• Last Update Posted: Nov 20, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Jânio do Nascimento Alves, Master Student, Universidade Federal de Pernambuco: perineal tear; pain; pelvic floor; Labour

Study Results

No Results Posted as of Nov 20, 2015