Clinical trial NCT02201615: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Labor Complications
Keywords: Perineal Massage; Episiotomy; Perineal Laceration
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 284
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Episiotomy procedures
timeFrame: until completed the second stage of labour, about from 30 min to 24 h
Secondary outcomes:
measure: Length of the second stage of labour
timeFrame: until completed the second stage of labour, about from 30 min to 24 h
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Cumhuriyet University
Study officials:
References:
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.