Perineal Laceration Involving SkinNCT03880552
Perineal Body Length and Perineal Lacerations
An observational study of Perineal Laceration Involving Skin and Delivery; Trauma, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Laceration Involving Skin, Delivery; Trauma
- What is being tested?
- Primigravid women with singleton pregnancy at 35th week over
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- -Primigravid women with singleton pregnancy at over 35th week
Who cannot join
- the story of operative vaginal birth;
- caesarean section;
- breech presentation;
- those with a history of anorectal surgery or trauma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: 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.
Read the 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.
- Being tested
- Primigravid women with singleton pregnancy at 35th week over
- Keywords
- perineal laceration, obstetric trauma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineal body length
The length of the perineal body will be measured in centimeters.
Measured: during delivery
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.
Measured: during delivery
Secondary outcomes (1)
genital hiatus length
The length of the genital hiatus will be measured in centimeters.
Measured: during delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Dec 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal Laceration Involving SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880552
- Sponsor's protocol ID
- 2018.12.68
- Status last verified
- Aug 2019
- First submitted
- 14 Mar 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineal Body Length and Perineal Lacerations During Delivery in Primigravid Patients
- ClinicalTrials.gov ID
- NCT03880552
- Acronym / sponsor ID
- 2018.12.68
- Keywords
- perineal laceration, obstetric trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- -Primigravid women with singleton pregnancy at over 35th week
Key exclusion criteria (4 listed)
- the story of operative vaginal birth;
- caesarean section;
- breech presentation;
- those with a history of anorectal surgery or trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primigravid women with singleton pregnancy at 35th week overPrimigravid women with singleton pregnancy at 35th week over; only observational study will be done in this group and the data will be recorded. | Other | – |
Primary outcome
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.
1 secondary outcome
genital hiatus length
Time frame: during delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perineal Laceration Involving Skin and Delivery; Trauma, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineal body length (time frame: during delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.