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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02201615
Other study ID # SBF - 005
Secondary ID GD01MD2958058
Status Completed
Phase N/A
First received July 23, 2014
Last updated August 26, 2014
Start date January 2010

Study information

Verified date August 2014
Source Cumhuriyet University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 284
Est. completion date
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 49 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Perineal massage in childbirth


Locations

Country Name City State
Turkey Cumhuriyet University Sivas

Sponsors (1)

Lead Sponsor Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Episiotomy procedures until completed the second stage of labour, about from 30 min to 24 h No
Secondary Length of the second stage of labour until completed the second stage of labour, about from 30 min to 24 h No
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