CClinicalTrials.gg
CompletedNCT03880552Updated Aug 14, 2019

Perineal Body Length and Perineal Lacerations

An observational study in Perineal Laceration Involving Skin and Delivery; Trauma, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-14.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Perineal Laceration Involving Skin
  • Delivery; Trauma

Browse trials for

Keywords

  • perineal laceration
  • obstetric trauma
03

In context

Lacerations

133 studies on the registry are indexed under Lacerations; 29 are open to participants now.

This study's enrollment of 300 is above the median of 108 across 20 observational studies indexed under Lacerations.

Browse Lacerations studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Inclusion criteria

-Primigravid women with singleton pregnancy at over 35th week

Exclusion criteria

Exclusion Criteria:

  • the story of operative vaginal birth;
  • caesarean section;
  • breech presentation;
  • those with a history of anorectal surgery or trauma
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No

Interventions

  • OtherPrimigravid women with singleton pregnancy at 35th week over

    Primigravid women with singleton pregnancy at 35th week over; only observational study will be done in this group and the data will be recorded.

06

What researchers measure

Primary outcomes

  1. Perineal body length

    The length of the perineal body will be measured in centimeters.

    Time frame: during delivery

  2. perineal laceration

    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.

    Time frame: during delivery

Secondary outcomes

  1. genital hiatus length

    The length of the genital hiatus will be measured in centimeters.

    Time frame: during delivery

07

Study locations

1 site
  • Kanuni Sultan Süleyman Training and Research Hospital
    Istanbul, 33404, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03880552
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Pınar Kadirogulları (pınar kadiroğulları M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Mar 19, 2019
Start date
Dec 1, 2018
Primary completion
Jun 1, 2019
Completion
Jun 1, 2019
Last update
Aug 14, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion