Perineal TearNCT02588508
Effectiveness of Warm Packs, Perineal Massage and Hands Off During Labour in the Perineal Outcomes.
A study testing Warm packs and Perineal massage in people with Perineal Tear, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perineal Tear
- What is being tested?
- Warm packs and Perineal massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- parturient in active phase of labour
- single fetus at term (37-42 weeks)
- bent cephalic fetal presentation
- parity less than four children
Who cannot join
- use any perineal preparation techniques during pregnancy
- clinical indication for caesarean section
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This study is a randomised controled trial.
- Conditions
- Perineal Tear
- Being tested
- Warm packs, Perineal massage
- Keywords
- perineal tear, pain, pelvic floor, Labour
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm packsProcedure or surgery
: The warm packs are held in the mother's perineum during birth. The warm packs are changed as needed to maintain warmth.
Perineal massageProcedure or surgery
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".
| Study group | Role | What they receive |
|---|---|---|
| Warm packs | Experimental | The warm packs are held in the mother's perineum during birth. The warm packs are changed as needed to maintain warmth. Receives: Procedure: Warm packs |
| Perineal massage | Experimental | 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". Receives: Procedure: Perineal massage |
| Hands off | No intervention | Hands off group does not receive any perineal manipulation and they are only observed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need of suture
Number of participants with perineal tear after vaginal delivery requiring suture (evaluated as yes or no).
Measured: 30 minutes
Secondary outcomes (6)
Grade of perineal tear
Perineal tear ranked 1st, 2nd, 3rd and 4th degree
Measured: 30 minutes
perineal edema
Perineal edema is scored 0-4 (0 = no edema; 4 = edema invades the perineal body) .
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 24 hours
Perineal tear
Number of participants with perineal tear after vaginal delivery (evaluated as yes or no).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Perineal TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jânio do Nascimento Alves, Universidade Federal de Pernambuco
- Investigators
- Caroline WS Ferreira, PHD, Study director, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588508
- Sponsor's protocol ID
- 0335932
- Status last verified
- Nov 2015
- First submitted
- 26 Oct 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Aasheim V, Nilsen AB, Lukasse M, Reinar LM. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006672. doi: 10.1002/14651858.CD006672.pub2.
PubMed 22161407Albers LL, Sedler KD, Bedrick EJ, Teaf D, Peralta P. Midwifery care measures in the second stage of labor and reduction of genital tract trauma at birth: a randomized trial. J Midwifery Womens Health. 2005 Sep-Oct;50(5):365-72. doi: 10.1016/j.jmwh.2005.05.012.
PubMed 16154062Albers 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. doi: 10.1111/j.0730-7659.2006.00085.x.
PubMed 16732773Albers LL, Borders N. Minimizing genital tract trauma and related pain following spontaneous vaginal birth. J Midwifery Womens Health. 2007 May-Jun;52(3):246-53. doi: 10.1016/j.jmwh.2006.12.008.
PubMed 17467591Althabe F, Belizan JM, Bergel E. Episiotomy rates in primiparous women in Latin America: hospital based descriptive study. BMJ. 2002 Apr 20;324(7343):945-6. doi: 10.1136/bmj.324.7343.945. No abstract available.
PubMed 11964339AMORIM, M. M. R. DE et al. Assistência humanizada ao parto no Instituto de Saúde Elpídio de Almeida (ISEA): resultados maternos. Revista Saúde & Ciência, v. v. I, n. n. 1, p. 80 - 7, 2010.
AMORIM, M. M. R. DE; PORTO, A. M. F.; SOUZA, A. S. R. Assistência ao segundo e terceiro períodos do trabalho de parto baseada em evidências. Femina, v. 38, n. 11, p. 583-91, 2010.
Beckmann MM, Garrett AJ. Antenatal perineal massage for reducing perineal trauma. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005123. doi: 10.1002/14651858.CD005123.pub2.
PubMed 16437520Carroli G, Belizan J. Episiotomy for vaginal birth. Cochrane Database Syst Rev. 2000;(2):CD000081. doi: 10.1002/14651858.CD000081.
PubMed 10796120COELHO, L. F. S. O treino de flexibilidade muscular e o aumento da amplitude de movimento: uma revisão crítica da literatura. Revista de Desporto e Saúde, v. 4, n. 3, p. 61-72, 2007.
de Souza Caroci da Costa A, Gonzalez Riesco ML. A comparison of "hands off" versus "hands on" techniques for decreasing perineal lacerations during birth. J Midwifery Womens Health. 2006 Mar-Apr;51(2):106-11. doi: 10.1016/j.jmwh.2005.10.017.
PubMed 16504907Dahlen HG, Homer CS, Cooke M, Upton AM, Nunn R, Brodrick B. Perineal outcomes and maternal comfort related to the application of perineal warm packs in the second stage of labor: a randomized controlled trial. Birth. 2007 Dec;34(4):282-90. doi: 10.1111/j.1523-536X.2007.00186.x.
PubMed 18021143Dahlen HG, Homer CS, Cooke M, Upton AM, Nunn RA, Brodrick BS. 'Soothing the ring of fire': Australian women's and midwives' experiences of using perineal warm packs in the second stage of labour. Midwifery. 2009 Apr;25(2):e39-48. doi: 10.1016/j.midw.2007.08.002. Epub 2007 Nov 26.
PubMed 18031878Elharmeel SM, Chaudhary Y, Tan S, Scheermeyer E, Hanafy A, van Driel ML. Surgical repair of spontaneous perineal tears that occur during childbirth versus no intervention. Cochrane Database Syst Rev. 2011 Aug 10;2011(8):CD008534. doi: 10.1002/14651858.CD008534.pub2.
PubMed 21833968Dahlen HG. Perineal warm compress reduces risk of third- and fourth- degree tears and should be part of second stage care. Evid Based Nurs. 2012 Oct;15(4):103-4. doi: 10.1136/ebnurs-2012-100685. Epub 2012 Jun 12. No abstract available.
PubMed 22691406
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Warm Packs, Perineal Massage and Hands Off During Labour in the Perineal Outcomes.
- ClinicalTrials.gov ID
- NCT02588508
- Acronym / sponsor ID
- 0335932
- Conditions
- Perineal Tear
- Keywords
- perineal tear, pain, pelvic floor, Labour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Warm packs | Experimental | Procedure: Warm packsThe warm packs are held in the mother's perineum during birth. The warm packs are changed as needed to maintain warmth. |
| Perineal massage | Experimental | Procedure: Perineal massageThe perineal massage will be gently held in the longitudinal direction of the muscle fibers, with movements of the thumb and forefinger, like "count coins". |
| Hands off | No intervention | –Hands off group does not receive any perineal manipulation and they are only observed. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- parturient in active phase of labour
- single fetus at term (37-42 weeks)
- bent cephalic fetal presentation
- parity less than four children
Key exclusion criteria (2 listed)
- use any perineal preparation techniques during pregnancy
- clinical indication for caesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Warm packs |
| Perineal massageThe 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 or surgery | Perineal massage |
Primary outcome
Need of suture
Time frame: 30 minutes
Number of participants with perineal tear after vaginal delivery requiring suture (evaluated as yes or no).
6 secondary outcomes
Grade of perineal tear
Time frame: 30 minutes
perineal edema
Time frame: 1 hour
Perineal pain
Time frame: 24 hours
Use of drugs for perineal pain
Time frame: 24 hours
Satisfaction with the technique used
Time frame: 24 hours
Perineal tear
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Background: PubMed 22161407Aasheim V, Nilsen AB, Lukasse M, Reinar LM. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006672. doi: 10.1002/14651858.CD006672.pub2.
- Background: PubMed 16154062Albers LL, Sedler KD, Bedrick EJ, Teaf D, Peralta P. Midwifery care measures in the second stage of labor and reduction of genital tract trauma at birth: a randomized trial. J Midwifery Womens Health. 2005 Sep-Oct;50(5):365-72. doi: 10.1016/j.jmwh.2005.05.012.
- Background: PubMed 16732773Albers 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. doi: 10.1111/j.0730-7659.2006.00085.x.
- Background: PubMed 17467591Albers LL, Borders N. Minimizing genital tract trauma and related pain following spontaneous vaginal birth. J Midwifery Womens Health. 2007 May-Jun;52(3):246-53. doi: 10.1016/j.jmwh.2006.12.008.
- Background: PubMed 11964339Althabe F, Belizan JM, Bergel E. Episiotomy rates in primiparous women in Latin America: hospital based descriptive study. BMJ. 2002 Apr 20;324(7343):945-6. doi: 10.1136/bmj.324.7343.945. No abstract available.
- BackgroundAMORIM, M. M. R. DE et al. Assistência humanizada ao parto no Instituto de Saúde Elpídio de Almeida (ISEA): resultados maternos. Revista Saúde & Ciência, v. v. I, n. n. 1, p. 80 - 7, 2010.
- BackgroundAMORIM, M. M. R. DE; PORTO, A. M. F.; SOUZA, A. S. R. Assistência ao segundo e terceiro períodos do trabalho de parto baseada em evidências. Femina, v. 38, n. 11, p. 583-91, 2010.
- Background: PubMed 16437520Beckmann MM, Garrett AJ. Antenatal perineal massage for reducing perineal trauma. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005123. doi: 10.1002/14651858.CD005123.pub2.
- Background: PubMed 10796120Carroli G, Belizan J. Episiotomy for vaginal birth. Cochrane Database Syst Rev. 2000;(2):CD000081. doi: 10.1002/14651858.CD000081.
- BackgroundCOELHO, L. F. S. O treino de flexibilidade muscular e o aumento da amplitude de movimento: uma revisão crítica da literatura. Revista de Desporto e Saúde, v. 4, n. 3, p. 61-72, 2007.
- Background: PubMed 16504907de Souza Caroci da Costa A, Gonzalez Riesco ML. A comparison of "hands off" versus "hands on" techniques for decreasing perineal lacerations during birth. J Midwifery Womens Health. 2006 Mar-Apr;51(2):106-11. doi: 10.1016/j.jmwh.2005.10.017.
- Background: PubMed 18021143Dahlen HG, Homer CS, Cooke M, Upton AM, Nunn R, Brodrick B. Perineal outcomes and maternal comfort related to the application of perineal warm packs in the second stage of labor: a randomized controlled trial. Birth. 2007 Dec;34(4):282-90. doi: 10.1111/j.1523-536X.2007.00186.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline WS Ferreira, PHD study director
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm packs and Perineal massage in people with Perineal Tear, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jânio N Alves, Graduate (+55 83 999812006, janiourofisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need of suture (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588508, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.