Obstetric Labor ComplicationsNCT02201615
The Effect of Perineal Massage in Childbirth
A study testing Perineal massage in childbirth in people with Obstetric Labor Complications, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Objective To examine the effects of perineal massage applied during the action of birth on the frequency of episiotomy procedures, perineal tearing and the duration of the second stage of birth. Methods The present study was a randomized controlled experimental. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Labor Complications
- What is being tested?
- Perineal massage in childbirth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2010to May 2011
- 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 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- With no pregnancy-related complications diagnosed during pregnancy,
- No definitive indication for C-section,
- Satisfying the pregnancy week in terms of the fetal dimensions,
- At the 37th-42nd gestation week,
- Applying to have her first or second birth,
- With no systemic condition,
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- With head presentation,
- At the latent phase of the first stage of birth with a dilatation under 4 cm and effacement below 50%,
- That have provided written consent specifying their voluntariness in participating in the study.
Who cannot join
- With pregnancy-related complications diagnosed during pregnancy,
- Definitive indication for C-section,
- No satisfying the pregnancy week in terms of the fetal dimensions,
- At the <37th- >42nd gestation week,
- With systemic condition,
- With no head presentation,
- At the latent phase of the first stage of birth with a dilatation above 4 cm
- No have provided written consent specifying their voluntariness in participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perineal Massage in Childbirth: the Rate of Episiotomy Procedures, Perineal Tears and the Length of the Second Stage of Labour
Objective To examine the effects of perineal massage applied during the action of birth on the frequency of episiotomy procedures, perineal tearing and the duration of the second stage of birth.
Methods The present study was a randomized controlled experimental. Women (284 women) were informed on the study and provided their written consent. 10-minute perineal massage with glycerine was applied to the women in the test group for 4 times during the first stage and 1 time in the second stage of birth. The women in the control group received the routine care procedure at the clinic.
Read more
Results According to the study findings, 31% of the women in the test group and 69.7% of the women in the control group were made subject to episiotomy (p<0.05). In the test and control group 9.2%, 2.4% of the women developed spontaneous perineal laceration (p>0.05). The average duration of the action of birth was 25.33 minutes in the test group and 28.18 minutes in the control group (p<0.05).
Conclusion The study results indicate that perineal massage applied during the action of birth decreased the rate of episiotomy procedure and shortened the duration of the second stage of birth.
- Conditions
- Obstetric Labor Complications
- Being tested
- Perineal massage in childbirth
- Keywords
- Perineal Massage; Episiotomy; Perineal Laceration
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal massage in childbirthOther
| Study group | Role | What they receive |
|---|---|---|
| Perineal Massage & Control | Experimental | Perineal Massage every 30 min, a 10 min 4 times in the first stage of labour, 1 times in the second stage of labour.
Control routine care procedure at the clinic. Receives: Other: Perineal massage in childbirth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episiotomy procedures
Measured: until completed the second stage of labour, about from 30 min to 24 h
Secondary outcomes (1)
Length of the second stage of labour
Measured: until completed the second stage of labour, about from 30 min to 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJan 2010
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetric Labor ComplicationsStudies 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
- Care provider
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulbahtiyar DEMİREL, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201615
- Sponsor's protocol ID
- SBF - 005
- Other IDs
- GD01MD2958058
- Status last verified
- Aug 2014
- First submitted
- 23 Jul 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Demirel G, Golbasi Z. Effect of perineal massage on the rate of episiotomy and perineal tearing. Int J Gynaecol Obstet. 2015 Nov;131(2):183-6. doi: 10.1016/j.ijgo.2015.04.048. Epub 2015 Jul 26.
PubMed 26410801
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perineal Massage in Childbirth: the Rate of Episiotomy Procedures, Perineal Tears and the Length of the Second Stage of Labour
- ClinicalTrials.gov ID
- NCT02201615
- Acronym / sponsor ID
- SBF - 005
- Conditions
- Obstetric Labor Complications
- Keywords
- Perineal Massage; Episiotomy; Perineal Laceration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- First posted
- 28 Jul 2014 (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.
Objective To examine the effects of perineal massage applied during the action of birth on the frequency of episiotomy procedures, perineal tearing and the duration of the second stage of birth.
Methods The present study was a randomized controlled experimental. Women (284 women) were informed on the study and provided their written consent. 10-minute perineal massage with glycerine was applied to the women in the test group for 4 times during the first stage and 1 time in the second stage of birth. The women in the control group received the routine care procedure at the clinic.
Results According to the study findings, 31% of the women in the test group and 69.7% of the women in the control group were made subject to episiotomy (p<0.05). In the test and control group 9.2%, 2.4% of the women developed spontaneous perineal laceration (p>0.05). The average duration of the action of birth was 25.33 minutes in the test group and 28.18 minutes in the control group (p<0.05).
Conclusion The study results indicate that perineal massage applied during the action of birth decreased the rate of episiotomy procedure and shortened the duration of the second stage of birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perineal Massage & Control | Experimental | Other: Perineal massage in childbirthPerineal Massage every 30 min, a 10 min 4 times in the first stage of labour, 1 times in the second stage of labour. Control routine care procedure at the clinic. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- With no pregnancy-related complications diagnosed during pregnancy,
- No definitive indication for C-section,
- Satisfying the pregnancy week in terms of the fetal dimensions,
- At the 37th-42nd gestation week,
- Applying to have her first or second birth,
Key exclusion criteria (8 listed)
- With pregnancy-related complications diagnosed during pregnancy,
- Definitive indication for C-section,
- No satisfying the pregnancy week in terms of the fetal dimensions,
- At the <37th- >42nd gestation week,
- With systemic condition,
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 |
|---|---|---|
| Perineal massage in childbirth | Other | Perineal Massage & Control |
Primary outcome
Episiotomy procedures
Time frame: until completed the second stage of labour, about from 30 min to 24 h
1 secondary outcome
Length of the second stage of labour
Time frame: until completed the second stage of labour, about from 30 min to 24 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
- Derived from this study: PubMed 26410801Demirel G, Golbasi Z. Effect of perineal massage on the rate of episiotomy and perineal tearing. Int J Gynaecol Obstet. 2015 Nov;131(2):183-6. doi: 10.1016/j.ijgo.2015.04.048. Epub 2015 Jul 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal massage in childbirth in people with Obstetric Labor Complications, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 27 Aug 2014. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episiotomy procedures (time frame: until completed the second stage of labour, about from 30 min to 24 h). 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 NCT02201615, which also lists 1 linked publication.
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 27 Aug 2014.