- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03880552
Perineal Body Length and Perineal Lacerations
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 33404
- Kanuni Sultan Suleyman Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
|
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
Studies a U.S. FDA-regulated device product
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
-
University of Alabama at BirminghamCompletedObstetric Labor Complications | Obstetric; Injury | Fourth Degree Perineal Laceration Involving Anal MucosaUnited States
-
Clinical Research Centre, MalaysiaCompletedPerineal Tear | Perineal Laceration (Obstetric)
-
Massachusetts General HospitalEnrolling by invitationPerineal Tear | Delivery; Trauma | Perineal LacerationUnited States
-
Medtronic - MITGTerminatedPerineal Laceration RepairUnited States
-
University of Texas Southwestern Medical CenterCompletedPerineal LacerationsUnited States
-
Lund University HospitalCompletedPerineal LacerationsSweden
-
University of AarhusAarhus University Hospital; Danish Research Agency; Aase and Ejnar Danielsens... and other collaboratorsCompletedEpisiotomy | Perineal LacerationsDenmark
-
Instituto Materno Infantil Prof. Fernando FigueiraSuspended
-
Virginia Commonwealth UniversityCompletedPerineal Tear | Dyspareunia | Sutured LacerationUnited States
Clinical Trials on Primigravid women with singleton pregnancy at 35th week over
-
Memorial Sloan Kettering Cancer CenterTufts Medical Center; Lahey ClinicCompleted