Sharp Versus Blunt Uterine Incision Expansion

Phase 2

• Conditions: Cesarean Section Complications
• Interventions: Procedure: blunt uterine incision expansion; Procedure: sharp uterine incision expansion

• Registration Number: NCT03377894
• Lead Sponsor: Kasr El Aini Hospital

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

Study Timeline

• Status Verified: 2017-12
• Study Start: 2017-12
• Study First Submitted: 2017-12-10
• Study First Submitted QC: 2017-12-13
• Last Update Submitted: 2017-12-13
• Study First Posted: 2017-12-19
• Last Update Posted: 2017-12-19
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
• Group (A) blunt incision	blunt uterine incision expansion	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
• Group (B) sharp incision	sharp uterine incision expansion	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

Primary Outcome Measures

Name	Time	Method
The operative time is recorded in minutes	from skin incision till skin closure	The operative time is recorded in minutes
intraoperative bleeding	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	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)

Trial Locations

Locations (1)

Kasr El Ainiy Hospital; 🇪🇬 Cairo, Egypt