The Effect of Perineal Protective Package Application on Pelvic Floor in Labor

NCT06428812 | Completed

• 1 other identifier: Hayatoktem02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effect of perineal protection package application on labor outcomes, perineal integrity, postpartum urinary incontinence and pelvic floor muscle strength.In this study, a package including practices that have been proven to protect the perineum in labor was created and it was aimed to examine the effect of this perineal protection package; as a whole. The;perineal protective package; applications created by the researchers consisted of positioning on the gynecologic table (the back of the table was erected, the legs were removed from the hooks and placed on the sides of the table), open glottis pushing instead of closed glottis pushing, hot compress protection of the perineum instead of dry compress protection of the perineum, instead of lithotomy position in the second stage, which reduces the tension of the perineum and allows it to be observed and protected manually.

Conditions

Pregnancy; Labor; Pelvic Floor

Outcome Measures

Primary Outcomes (2)

• Perineal muscle strengt

  Perineal muscle strength will be measured in cmH2o with a perineometer.

  On initial admission to the delivery room and after 6 weeks postpartum

• Perineal Pain

  Perineal pain will be assessed by VAS at the beginning and end of the second stage of labor and at the end of the 1st hour postpartum.

  1st hour postpartum

Secondary Outcomes (2)

• Episiotomy and laseration status

  1st hour postpartum

• Urinary incontinence status

  6 weeks postpartum

Study Arms (2)

perineal package application group

EXPERIMENTAL

This group includes those in the 2nd stage of labor upright position spontaneous pushing Hot application will be made

Other: Experimental: perineal package application group

Routine hospital care

NO INTERVENTION

Routine hospital care

Interventions

Experimental: perineal package application group OTHER

This group includes those in the 2nd stage of labor upright position spontaneous pushing Hot application will be made

perineal package application group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Primipar
• Singleton pregnancy in the vertex position between 38 and 42 weeks
• A reactive NST tracing
• Without a systemic disease (heart, HT, diabetes)
• No problem speaking and understanding Turkish
• Who agreed to participate in the study

You may not qualify if:

• Obese pregnant women
• Pregnant women who gained more than 25 kilograms during pregnancy
• Multiple pregnancies
• Pregnant women with a neurological disease affecting the pelvic floor
• Pregnant women who have undergone pelvic surgery
• Contraindications for normal delivery (placenta previa, anomalies of presentation, etc.)
• Estimated fetal weight of 4000 g or more
• Who wants to opt out of the study
• Pregnant women who are scheduled for cesarean section at any time of trauma

Sponsors & Collaborators

• Öznur Hayat Öktem: lead

Study Sites (1)

Karabuk Training and Research Hospital, obstetrics clinic

Karabük, 78100, Turkey (Türkiye)

Location

Related Publications (1)

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  BACKGROUND

Study Officials

• Nazan KARAHAN, Associate professor

  Gulhane School of Medicine

  STUDY DIRECTOR

• MEHMET BÜLBÜL, Associate professor

  Karabuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Phd student Msc midwife

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 24, 2024
• Study Start: July 8, 2024
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)