- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02201615
The Effect of Perineal Massage in Childbirth
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sivas, Turkey, 58140
- Cumhuriyet University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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,
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perineal Massage & Control
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Episiotomy procedures
Time Frame: until completed the second stage of labour, about from 30 min to 24 h
|
until completed the second stage of labour, about from 30 min to 24 h
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of the second stage of labour
Time Frame: until completed the second stage of labour, about from 30 min to 24 h
|
until completed the second stage of labour, about from 30 min to 24 h
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBF - 005
- GD01MD2958058 (Registry Identifier: GD01MD2958058)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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