Obstetric Labor ComplicationsPhase 2IAMENCT01930721
Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees
A Phase 2 study testing episiotomy in people with Obstetric Labor Complications, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The angle at which an episiotomy can be made is a continuous variable. If the investigators consider midline to be 0 degrees and a lateral episiotomy (never used today) to be 90 degrees, then it is theoretically possible to choose any angle from 0 to 90 degrees. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Labor Complications
- 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
- 330 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2012to Sep 2013
- Phase
- Phase 2
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primigravida with singleton pregnancy presenting by vertex.
- Gestational age > 37 weeks
- No instrumental delivery.
- No fetal distress or any emergency
Who cannot join
- Women had an episiotomy because of fetal distress and for technical reasons (emergency or episiotomy incised prior to the fetal head crowning the perineum.
- Inability to understand the informed consent.
Trial locations and contacts
1 site in 1 country.
shafik adel, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Unversity Hospitals
Cairo
adel shafik, lecturer, 01005223586, shafikadel@yahoo.com
malka ameen
About this study
The angle at which an episiotomy can be made is a continuous variable. If the investigators consider midline to be 0 degrees and a lateral episiotomy (never used today) to be 90 degrees, then it is theoretically possible to choose any angle from 0 to 90 degrees.
Read the detailed description
Episiotomy is a surgical incision to the perineum in order to enlarge the vaginal orifice during the second stage of labor. Although seven types of episiotomy have been described in the literature , the most frequently performed types are the mediolateral and median episiotomies, with the former being the most common one. Despite being a common obstetric practice, the exact definition of a "mediolateral" episiotomy is often unclear. Several studies and reports, however, stated that a significant proportion of the so-claimed mediolateral episiotomy were not actually mediolateral. The current trial compares two angles of mediolateral episiotomy , regarding the risk of third- and fourth-degree perineal tearing, episiotomy-related pain and dyspareunia in primiparous women at a large tertiary maternity center, namely Ain Shams University Maternity Hospital, Cairo, Egypt.
- Conditions
- Obstetric Labor Complications
- Being tested
- episiotomy
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
episiotomyProcedure or surgery
incision angle of episiotomy will be 60 degrees.
episiotomyProcedure or surgery
incision angle of episiotomy will be 40 degree before cutting.
| Study group | Role | What they receive |
|---|---|---|
| incision angle of 60 degrees | Experimental | episiotomy incision angle will be defined as 60 degree as measured before cutting. Receives: Procedure: episiotomy |
| incision angle 40 degree episiotomy | Experimental | incision angle of episiotomy will be defined as 40 degree as measured before cutting. Receives: Procedure: episiotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
and fourth degree perineal tears.
DESCRIBING THIRD AND FOURTH degree perieneal tears as regarding repair and post operative pain
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetric Labor ComplicationsStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, malka amen, Ain Shams Maternity Hospital
- Investigators
- ADEL SH SLAH EL-DIN, MD, Principal investigator, LECTURER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930721
- Sponsor's protocol ID
- incision angle of mediolateral
- Acronym
- IAME
- Status last verified
- Aug 2013
- First submitted
- 16 Jun 2012
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Din AS, Kamal MM, Amin MA. Comparison between two incision angles of mediolateral episiotomy in primiparous women: a randomized controlled trial. J Obstet Gynaecol Res. 2014 Jul;40(7):1877-82. doi: 10.1111/jog.12432.
PubMed 25056465
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees
- ClinicalTrials.gov ID
- NCT01930721
- Acronym / sponsor ID
- IAME / incision angle of mediolateral
- Conditions
- Obstetric Labor Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 29 Aug 2013 (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.
The angle at which an episiotomy can be made is a continuous variable. If the investigators consider midline to be 0 degrees and a lateral episiotomy (never used today) to be 90 degrees, then it is theoretically possible to choose any angle from 0 to 90 degrees.
Detailed description
Episiotomy is a surgical incision to the perineum in order to enlarge the vaginal orifice during the second stage of labor. Although seven types of episiotomy have been described in the literature , the most frequently performed types are the mediolateral and median episiotomies, with the former being the most common one. Despite being a common obstetric practice, the exact definition of a "mediolateral" episiotomy is often unclear. Several studies and reports, however, stated that a significant proportion of the so-claimed mediolateral episiotomy were not actually mediolateral. The current trial compares two angles of mediolateral episiotomy , regarding the risk of third- and fourth-degree perineal tearing, episiotomy-related pain and dyspareunia in primiparous women at a large tertiary maternity center, namely Ain Shams University Maternity Hospital, Cairo, Egypt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| incision angle of 60 degrees | Experimental | Procedure: episiotomyepisiotomy incision angle will be defined as 60 degree as measured before cutting. |
| incision angle 40 degree episiotomy | Experimental | Procedure: episiotomyincision angle of episiotomy will be defined as 40 degree as measured before cutting. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primigravida with singleton pregnancy presenting by vertex.
- Gestational age > 37 weeks
- No instrumental delivery.
- No fetal distress or any emergency
Key exclusion criteria (2 listed)
- Women had an episiotomy because of fetal distress and for technical reasons (emergency or episiotomy incised prior to the fetal head crowning the perineum.
- Inability to understand the informed consent.
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 |
|---|---|---|
| episiotomyincision angle of episiotomy will be 60 degrees. | Procedure or surgery | incision angle 40 degree episiotomy |
| episiotomyincision angle of episiotomy will be 40 degree before cutting. | Procedure or surgery | incision angle of 60 degrees |
Primary outcome
and fourth degree perineal tears.
Time frame: intraoperative
DESCRIBING THIRD AND FOURTH degree perieneal tears as regarding repair and post operative pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
- Derived from this study: PubMed 25056465El-Din AS, Kamal MM, Amin MA. Comparison between two incision angles of mediolateral episiotomy in primiparous women: a randomized controlled trial. J Obstet Gynaecol Res. 2014 Jul;40(7):1877-82. doi: 10.1111/jog.12432.
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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.
shafik adel, MD contact
ADEL SH SLAH EL-DIN, MD principal investigator
LECTURER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing episiotomy in people with Obstetric Labor Complications, run by Ain Shams Maternity Hospital 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Aug 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shafik adel, MD (shafikadel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
and fourth 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?
On the ClinicalTrials.gov record for NCT01930721, which also lists 1 linked publication.
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 29 Aug 2013.