NCT03880552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

March 14, 2019

Last Update Submit

August 13, 2019

Conditions

Perineal Laceration Involving SkinDelivery; Trauma

Keywords

perineal lacerationobstetric trauma

Outcome Measures

Primary Outcomes (2)

  • Perineal body length

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

    during delivery

  • 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.

    during delivery

Secondary Outcomes (1)

  • genital hiatus length

    during delivery

Interventions

Primigravid women with singleton pregnancy at 35th week overOTHER

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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Primigravid women with singleton pregnancy at over 35th week

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pınar kadiroğulları M.D, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 19, 2019

Study Start

December 1, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

TU(1)