Sharp Versus Blunt Uterine Incision Expansion

Cesarean Section Complications Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03377894
• Other study ID #: 336695
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: December 10, 2017
• Last updated: December 13, 2017
• Start date: December 2017
• Est. completion date: March 2018

Study information

• Verified date: December 2017
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Procedure:
• blunt uterine incision expansion
blunt uterine incision expansion
• sharp uterine incision expansion
sharp uterine incision expansion

Locations

Country	Name	City	State
Egypt	Kasr El Ainiy Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	The operative time is recorded in minutes	The operative time is recorded in minutes	from skin incision till skin closure