Perineal Body Length and Perineal Lacerations

August 13, 2019 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

Perineal Body Length and Perineal Lacerations During Delivery in Primigravid Patients

The aim of this study was to evaluate the relationship between perineal body length and perineal laceration risk in primigravid patients.

Primigravid women with singleton pregnancies in the first stage of labor at the 35th week of gestation were included in the study. The peineal body length of the patients was measured by the same physician.

Study Overview

Detailed Description

After 35 weeks of gestation, nulliparous women with single gestation were included in the study and genital hiatus and perineal body measurements were taken.

The presence and degree of perineal laceration after birth were determined. Correlation of genital hiatus and perineal body measurements with perineal laceration risk were evaluated.

After birth, vaginal laceration, oxytocin use, fetal birth weight, the presence of episiotomy were recorded.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 33404
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Meet the criteria of inclusion in our hospital for birth,The study was planned for women with singleton pregnancies of 35 weeks or more.

Description

Inclusion Criteria:

-Primigravid women with singleton pregnancy at over 35th week

Exclusion Criteria:

  • the story of operative vaginal birth;
  • caesarean section;
  • breech presentation;
  • those with a history of anorectal surgery or trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perineal body length
Time Frame: during delivery
The length of the perineal body will be measured in centimeters.
during delivery
perineal laceration
Time Frame: during delivery

Laceration measurement 1.-2.-3.-4. degree. The measurement of laceration will be graded.

  1. st degree laceration is the tears formed in the vaginal epithelium and perineum skin.
  2. nd degree laceration includes perineal muscles. 3. Degree lacerations extend to the anal sphinkter complex. In the 4th degree laceration, the anal epithelium / rectal mucosa was also torn.
during delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
genital hiatus length
Time Frame: during delivery
The length of the genital hiatus will be measured in centimeters.
during delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018.12.68

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Perineal Laceration Involving Skin

Clinical Trials on Primigravid women with singleton pregnancy at 35th week over

3
Subscribe