The Effect of Perineal Massage in Childbirth | NCT02201615

Studies
The Effect of Perineal Massage in Childbirth

NCT02201615

Sponsor

Cumhuriyet University

Status

Completed

Last Update Posted

Aug 27, 2014Estimated

Enrollment

284Actual

Phase

Not Applicable

Conditions

Obstetric Labor Complications

Interventions

Perineal massage in childbirth

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
GD01MD2958058	Registry Identifier	GD01MD2958058

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

May 2011Actual

Completion Date

Not provided

First Submitted Date

Jul 23, 2014

First Submission Date that Met QC Criteria

Jul 24, 2014

First Posted Date

Jul 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2014

Last Update Posted Date

Aug 27, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

284Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Perineal massage in childbirth	Other		Perineal Massage & Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Episiotomy procedures		until completed the second stage of labour, about from 30 min to 24 h

Secondary Outcomes

Measure	Description	Time Frame
Length of the second stage of labour		until completed the second stage of labour, about from 30 min to 24 h

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Cumhuriyet University		Sivas		58140	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26410801	Derived	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.

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D011247	Pregnancy
D012098	Reproduction
D055703	Reproductive Physiological Phenomena
D012101	Reproductive and Urinary Physiological Phenomena