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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02588508
Enrollment
201
Registered
2015-10-27
Start date
2015-04-30
Completion date
2016-01-31
Last updated
2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perineal Tear

Keywords

perineal tear, pain, pelvic floor, Labour

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.

Interventions

PROCEDUREWarm packs

: The warm packs are held in the mother's perineum during birth. The warm packs are changed as needed to maintain warmth.

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.

Sponsors

Universidade Federal de Pernambuco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frameDescription
Need of suture30 minutesNumber of participants with perineal tear after vaginal delivery requiring suture (evaluated as yes or no).

Secondary

MeasureTime frameDescription
perineal edema1 hourPerineal edema is scored 0-4 (0 = no edema; 4 = edema invades the perineal body) .
Perineal pain24 hoursself reported ´perineal pain intensity. Perineal pain is scored 0-10 (0 = no pain; 10 = pain as bad as can be).
Grade of perineal tear30 minutesPerineal tear ranked 1st, 2nd, 3rd and 4th degree
Satisfaction with the technique used24 hoursSatisfaction of the woman with the technique used for perineal care. Satisfaction is scored 0-4 (0 = very satisfied; 4 = very dissatisfied)
Perineal tear30 minutesNumber of participants with perineal tear after vaginal delivery (evaluated as yes or no).
Use of drugs for perineal pain24 hoursNumber of participants using drugs for perineal pain at the time of 24 hours after vaginal delivery (evaluated as yes or no).

Countries

Brazil

Contacts

Primary ContactJânio N Alves, Graduate
janiourofisio@gmail.com+55 83 999812006
Backup ContactMelania MR Amorim, PHD
melamorim@uol.com.br+5583988221514

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026