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Clinical Trials/NCT03377894
NCT03377894
Unknown
Phase 2

Comparison Between Blunt Versus Sharp Expansion of Uterine Incision at Lower Segment Cesarean Section as Regards the Intra-operative Blood Loss & Postoperative Pain

Kasr El Aini Hospital1 site in 1 country200 target enrollmentDecember 2017

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cesarean Section Complications
Sponsor
Kasr El Aini Hospital
Enrollment
200
Locations
1
Primary Endpoint
The operative time is recorded in minutes
Last Updated
8 years ago

Overview

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

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

Registry
clinicaltrials.gov
Start Date
December 2017
End Date
March 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Kasr El Aini Hospital
Responsible Party
Principal Investigator
Principal Investigator

sarah mohamed hassan

lecturer of obstetrics and gynecology

Kasr El Aini Hospital

Eligibility Criteria

Inclusion Criteria

  • singleton pregnancy.

Exclusion Criteria

  • previous PID
  • any medical or psychiatric
  • patients with BMI ≥ 40
  • multigravidas
  • chronic analgesia use,
  • allergy to analgesics,
  • multiple pregnancies are also excluded

Outcomes

Primary Outcomes

The operative time is recorded in minutes

Time Frame: from skin incision till skin closure

The operative time is recorded in minutes

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).

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)

Study Sites (1)

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