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Perineal Body Length and Perineal Lacerations

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ClinicalTrials.gov Identifier: NCT03880552
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

Brief 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.


Condition or disease Intervention/treatment
Perineal Laceration Involving Skin Delivery; Trauma Other: Primigravid women with singleton pregnancy at 35th week over

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.


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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perineal Body Length and Perineal Lacerations During Delivery in Primigravid Patients
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears


Intervention Details:
  • Other: Primigravid 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.


Primary Outcome Measures :
  1. Perineal body length [ Time Frame: during delivery ]
    The length of the perineal body will be measured in centimeters.

  2. 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.


Secondary Outcome Measures :
  1. genital hiatus length [ Time Frame: during delivery ]
    The length of the genital hiatus will be measured in centimeters.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880552


Locations
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Turkey
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, Turkey, 33404
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital

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Responsible Party: Pınar Kadirogulları, pınar kadiroğulları M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03880552     History of Changes
Other Study ID Numbers: 2018.12.68
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital:
perineal laceration
obstetric trauma

Additional relevant MeSH terms:
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Lacerations
Wounds and Injuries