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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

Tracking Information
First Submitted Date March 14, 2019
First Posted Date March 19, 2019
Last Update Posted Date August 14, 2019
Actual Study Start Date December 1, 2018
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 2019)
  • Perineal body length [ Time Frame: during delivery ]
    The length of the perineal body will be measured in centimeters.
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03880552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 15, 2019)
genital hiatus length [ Time Frame: during delivery ]
The length of the genital hiatus will be measured in centimeters.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Perineal Body Length and Perineal Lacerations
Official Title Perineal Body Length and Perineal Lacerations During Delivery in Primigravid Patients
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Perineal Laceration Involving Skin
  • Delivery; Trauma
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 15, 2019)
300
Original Estimated Enrollment Same as current
Actual Study Completion Date June 1, 2019
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03880552
Other Study ID Numbers 2018.12.68
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
Study Sponsor Kanuni Sultan Suleyman Training and Research Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Kanuni Sultan Suleyman Training and Research Hospital
Verification Date August 2019