Cesarean Section ComplicationsPhase 2/3NCT03377894
Sharp Versus Blunt Uterine Incision Expansion
A Phase 2/3 study testing blunt uterine incision expansion and sharp uterine incision expansion in people with Cesarean Section Complications, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
comparison between blunt versus sharp expansion of uterine incision at lower segment cesarean section in primigravida as regards the intra-operative blood loss \& postoperative pain Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- blunt uterine incision expansion and sharp uterine incision expansion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2017to Mar 2018
- Phase
- Phase 2/3
- 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 20 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton pregnancy.
Who cannot join
- previous PID
- any medical or psychiatric
- patients with BMI ≥ 40
- multigravidas
- chronic analgesia use,
- allergy to analgesics,
- multiple pregnancies are also excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Blunt Versus Sharp Expansion of Uterine Incision at Lower Segment Cesarean Section as Regards the Intra-operative Blood Loss & Postoperative Pain
comparison between blunt versus sharp expansion of uterine incision at lower segment cesarean section in primigravida as regards the intra-operative blood loss \& postoperative pain
Read the detailed description
the study includes 200 pregnant women, primigravidas, at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy.
The patients are divided randomly into two groups as follows:
- Group (A): undergoing blunt uterine incision expansion
- Group (B): undergoing sharp uterine incision expansion
- Conditions
- Cesarean Section Complications
- Being tested
- blunt uterine incision expansion, sharp uterine incision expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blunt uterine incision expansionProcedure or surgery
blunt uterine incision expansion
sharp uterine incision expansionProcedure or surgery
sharp uterine incision expansion
| Study group | Role | What they receive |
|---|---|---|
| • Group (A) blunt incision | Active comparator | 100 primigravidas at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy.
undergoing blunt uterine incision expansion Receives: Procedure: blunt uterine incision expansion |
| • Group (B) sharp incision | Active comparator | 100 primigravidas, at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy undergoing sharp uterine incision expansion Receives: Procedure: sharp uterine incision expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
Post-operative pain is analyzed by using 4 point verbal rating scale (VRS) which consists of a list of adjectives describing different levels of pain intensity i.e (no pain =1, mild pain = 2, moderate pain = 3, severe pain = 4)
Measured: one hour after cs
intraoperative bleeding
The intra-operative blood loss is evaluated by towels as follows:
The surgical towels will be weighed (gm) before and after the operation, and the difference in weight between dry and soaked towels will be calculated. Blood loss during the operation will be calculated by adding the volume of the contents of the suction bottle (ml) to the difference in weight of towels (gm) (weight of soaked towels - weight of dry towels).
Measured: from skin incision till skin closure
The operative time is recorded in minutes
The operative time is recorded in minutes
Measured: from skin incision till skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study startDec 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section 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 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah mohamed hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377894
- Sponsor's protocol ID
- 336695
- Status last verified
- Dec 2017
- First submitted
- 10 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Blunt Versus Sharp Expansion of Uterine Incision at Lower Segment Cesarean Section as Regards the Intra-operative Blood Loss & Postoperative Pain
- ClinicalTrials.gov ID
- NCT03377894
- Acronym / sponsor ID
- 336695
- Conditions
- Cesarean Section Complications
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 19 Dec 2017 (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.
comparison between blunt versus sharp expansion of uterine incision at lower segment cesarean section in primigravida as regards the intra-operative blood loss \& postoperative pain
Detailed description
the study includes 200 pregnant women, primigravidas, at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy.
The patients are divided randomly into two groups as follows:
- Group (A): undergoing blunt uterine incision expansion
- Group (B): undergoing sharp uterine incision expansion
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • Group (A) blunt incision | Active comparator | Procedure: blunt uterine incision expansion100 primigravidas at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy. undergoing blunt uterine incision expansion |
| • Group (B) sharp incision | Active comparator | Procedure: sharp uterine incision expansion100 primigravidas, at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy undergoing sharp uterine incision expansion |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- singleton pregnancy.
Key exclusion criteria (7 listed)
- previous PID
- any medical or psychiatric
- patients with BMI ≥ 40
- multigravidas
- chronic analgesia use,
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 |
|---|---|---|
| blunt uterine incision expansionblunt uterine incision expansion | Procedure or surgery | • Group (A) blunt incision |
| sharp uterine incision expansionsharp uterine incision expansion | Procedure or surgery | • Group (B) sharp incision |
Primary outcome
post operative pain
Time frame: one hour after cs
Post-operative pain is analyzed by using 4 point verbal rating scale (VRS) which consists of a list of adjectives describing different levels of pain intensity i.e (no pain =1, mild pain = 2, moderate pain = 3, severe pain = 4)
intraoperative bleeding
Time frame: from skin incision till skin closure
The intra-operative blood loss is evaluated by towels as follows: The surgical towels will be weighed (gm) before and after the operation, and the difference in weight between dry and soaked towels will be calculated. Blood loss during the operation will be calculated by adding the volume of the contents of the suction bottle (ml) to the difference in weight of towels (gm) (weight of soaked towels - weight of dry towels).
The operative time is recorded in minutes
Time frame: from skin incision till skin closure
The operative time is recorded in minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
Related trials for Cesarean Section Complications
Not yet recruitingObservational study
Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia
Cesarean Section (MeSH: D002585), Anesthesia
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Not yet recruiting
LI4 and SP6 Acupuncture for Pain After Cesarean Delivery
Acute Postoperative Pain After Cesarean Delivery
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Postpartum Hemorrhage, Uterine Atony
Recruiting
Effects of Music Therapy, Breathing Exercises, and Virtual Reality on Obstetric Recovery, Pain, and Gastrointestinal Symptoms After Cesarean Section
Cesarean Section, Cesarean Section Pain
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 Phase 2/3 study testing blunt uterine incision expansion and sharp uterine incision expansion in people with Cesarean Section Complications, run by Kasr El Aini 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 1 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: status not confirmed, as of the sponsor's last update on 19 Dec 2017. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
post operative pain (time frame: one hour after cs). The study lists 3 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 19 Dec 2017.