Perineal Body Length and Perineal Lacerations

Delivery; Trauma Clinical Trial

Official title:

Perineal Body Length and Perineal Lacerations During Delivery in Primigravid Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880552
• Other study ID #: 2018.12.68
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: August 2019
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Delivery; Trauma
• Lacerations
• Perineal Laceration Involving Skin

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.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perineal body length	The length of the perineal body will be measured in centimeters.	during delivery
Primary	perineal laceration	Laceration measurement 1.-2.-3.-4. degree. The measurement of laceration will be graded.; st degree laceration is the tears formed in the vaginal epithelium and perineum skin.; 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	genital hiatus length	The length of the genital hiatus will be measured in centimeters.	during delivery