The Effect of Perineal Massage in Childbirth
Primary Purpose
Obstetric Labor Complications
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Perineal massage in childbirth
Sponsored by
About this trial
This is an interventional prevention trial for Obstetric Labor Complications focused on measuring Perineal Massage; Episiotomy; Perineal Laceration
Eligibility Criteria
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.
Sites / Locations
- Cumhuriyet University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Perineal Massage & Control
Arm Description
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.
Outcomes
Primary Outcome Measures
Episiotomy procedures
Secondary Outcome Measures
Length of the second stage of labour
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02201615
Brief Title
The Effect of Perineal Massage in Childbirth
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cumhuriyet University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor Complications
Keywords
Perineal Massage; Episiotomy; Perineal Laceration
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perineal Massage & Control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Perineal massage in childbirth
Primary Outcome Measure Information:
Title
Episiotomy procedures
Time Frame
until completed the second stage of labour, about from 30 min to 24 h
Secondary Outcome Measure Information:
Title
Length of the second stage of labour
Time Frame
until completed the second stage of labour, about from 30 min to 24 h
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Cumhuriyet University
City
Sivas
ZIP/Postal Code
58140
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
26410801
Citation
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.
Results Reference
derived
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The Effect of Perineal Massage in Childbirth
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