Normal LaborTSSNCT02717676
Prediction of Perineal Tears by Striae Gravidarum Score
A study testing Episiotomy in people with Normal Labor, run by Assiut University at 1 site in Egypt.
Trial summary
Previous studies concluded that striae gravidarum assessment appears to predict the occurrence of perineal tears and recommend training the health personnel to calculate the total striae score which can help them decide if episiotomy is to be given or not. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Normal Labor
- What is being tested?
- Episiotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to 2 Jun 2018
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Multipara
- Singleton pregnancy
- Full-term (37- 40 weeks)
- Average size fetus (2500-4000 gm)
- Cephalic-vertex presentation
- Spontaneous onset of labor
Show all 10Show fewer
- No scarred uterus
- No medical diseases as hypertension
- No obstetric complications as obstructed labor
- Women accepted to participate in the study
Who cannot join
- Multiple pregnancy
- Women with Previous cesarean sections
- Preterm labor
- Malpresentation
- Fetal macrosomia
- Medical diseases as diabetes and hypertension
- Women refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Episiotomy for Prevention of Perineal Tears During Labor in Women With High Striae Gravidarum Score
Previous studies concluded that striae gravidarum assessment appears to predict the occurrence of perineal tears and recommend training the health personnel to calculate the total striae score which can help them decide if episiotomy is to be given or not. Episiotomy definitely seems to be preventive for perineal tears but giving episiotomy for the same is still debatable as episiotomy in itself is associated with morbidity. the hypothesis is episiotomy done in patients with high score will definitely protects against perineal tears. So, the aim of study is to determine whether assessment of striae gravidarum score could predict occurrence of tears during labor or not, and if episiotomy will prevent perineal tears in women with high score.
- Conditions
- Normal Labor
- Being tested
- Episiotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpisiotomyProcedure or surgery
episiotomy will be done after crowning of the fetal head
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Episiotomy Receives: Procedure: Episiotomy |
| Group B | No intervention | no episiotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of third and forth degree perineal tears
Measured: intraoperative
Secondary outcomes (1)
Rate of first and second degree perineal tears
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion2 Apr 2018
- Study completion2 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal LaborStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717676
- Sponsor's protocol ID
- TSS
- Acronym
- TSS
- Status last verified
- Aug 2019
- First submitted
- 13 Mar 2016
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Episiotomy for Prevention of Perineal Tears During Labor in Women With High Striae Gravidarum Score
- ClinicalTrials.gov ID
- NCT02717676
- Acronym / sponsor ID
- TSS / TSS
- Conditions
- Normal Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 2 Jun 2018 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
Previous studies concluded that striae gravidarum assessment appears to predict the occurrence of perineal tears and recommend training the health personnel to calculate the total striae score which can help them decide if episiotomy is to be given or not. Episiotomy definitely seems to be preventive for perineal tears but giving episiotomy for the same is still debatable as episiotomy in itself is associated with morbidity. the hypothesis is episiotomy done in patients with high score will definitely protects against perineal tears. So, the aim of study is to determine whether assessment of striae gravidarum score could predict occurrence of tears during labor or not, and if episiotomy will prevent perineal tears in women with high score.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: EpisiotomyEpisiotomy |
| Group B | No intervention | –no episiotomy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Multipara
- Singleton pregnancy
- Full-term (37- 40 weeks)
- Average size fetus (2500-4000 gm)
- Cephalic-vertex presentation
Key exclusion criteria (7 listed)
- Multiple pregnancy
- Women with Previous cesarean sections
- Preterm labor
- Malpresentation
- Fetal macrosomia
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 |
|---|---|---|
| Episiotomyepisiotomy will be done after crowning of the fetal head | Procedure or surgery | Group A |
Primary outcome
Rate of third and forth degree perineal tears
Time frame: intraoperative
1 secondary outcome
Rate of first and second degree perineal tears
Time frame: intraoperative
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 20 Aug 2019.
- Individual participant dataSharing planned: Yes
Related trials for Normal Labor
Not yet recruitingObservational study
Comparison Between Using 10min CTG in Fetal Monitoring Instead of 30min Monitoring in Low Resources Overcrowded Hospitals.
Normal Pregnancy, Labor Active Dilated Cm
RecruitingPhase 4
Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor
Vaginal Delivery, Normal Labor
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?
A study testing Episiotomy in people with Normal Labor, run by Assiut University at 1 site in Egypt.
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 10 inclusion and 7 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 20 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 Egypt. 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?
Rate of third and forth degree perineal tears (time frame: intraoperative). 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 20 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.