Sharp Versus Blunt Uterine Incision Expansion
Comparison Between Blunt Versus Sharp Expansion of Uterine Incision at Lower Segment Cesarean Section as Regards the Intra-operative Blood Loss & Postoperative Pain
1 other identifier
interventional
200
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2017
Shorter than P25 for phase_2
1 active site
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, 2017
CompletedFirst Submitted
Initial submission to the registry
December 10, 2017
CompletedFirst Posted
Study publicly available on registry
December 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedDecember 19, 2017
December 1, 2017
3 months
December 10, 2017
December 13, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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)
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).
from skin incision till skin closure
The operative time is recorded in minutes
The operative time is recorded in minutes
from skin incision till skin closure
Study Arms (2)
• Group (A) blunt incision
ACTIVE COMPARATOR100 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 COMPARATOR100 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
Interventions
Eligibility Criteria
You may qualify if:
- singleton pregnancy.
You may not qualify if:
- previous PID
- any medical or psychiatric
- patients with BMI ≥ 40
- multigravidas
- chronic analgesia use,
- allergy to analgesics,
- multiple pregnancies are also excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kasr El Ainiy Hospital
Cairo, 11562, Egypt
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of obstetrics and gynecology
Study Record Dates
First Submitted
December 10, 2017
First Posted
December 19, 2017
Study Start
December 1, 2017
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
December 19, 2017
Record last verified: 2017-12