The Effect of Perineal Massage in Childbirth

NCT ID: NCT02201615

Last Updated: 2014-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstetric Labor Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Perineal Massage & Control

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.

Group Type EXPERIMENTAL

Perineal massage in childbirth

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Perineal massage in childbirth

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cumhuriyet University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gulbahtiyar DEMİREL

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cumhuriyet University

Sivas, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26410801 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GD01MD2958058

Identifier Type: REGISTRY

Identifier Source: secondary_id

SBF - 005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.