NCT02201615

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
Last Updated

August 27, 2014

Status Verified

August 1, 2014

Enrollment Period

1.3 years

First QC Date

July 23, 2014

Last Update Submit

August 26, 2014

Conditions

Obstetric Labor Complications

Keywords

Perineal Massage; Episiotomy; Perineal Laceration

Outcome Measures

Primary Outcomes (1)

  • Episiotomy procedures

    until completed the second stage of labour, about from 30 min to 24 h

Secondary Outcomes (1)

  • Length of the second stage of labour

    until completed the second stage of labour, about from 30 min to 24 h

Study Arms (1)

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.

Other: Perineal massage in childbirth

Interventions

Perineal massage in childbirthOTHER
Perineal Massage & Control

Eligibility Criteria

Age19 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 26410801DERIVED

MeSH Terms

Conditions

Obstetric Labor Complications

Interventions

Parturition

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 23, 2014

First Posted

July 28, 2014

Study Start

January 1, 2010

Primary Completion

May 1, 2011

Last Updated

August 27, 2014

Record last verified: 2014-08

Locations

TU(1)