Sharp Versus Blunt Uterine Incision Expansion

December 13, 2017 updated by: sarah mohamed hassan, Kasr El Aini Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Kasr El Ainiy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 37 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: • Group (A) blunt incision

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
Procedure: blunt uterine incision expansion
blunt uterine incision expansion
ACTIVE_COMPARATOR: • Group (B) sharp incision
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
Procedure: sharp uterine incision expansion
sharp uterine incision expansion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
one hour after cs
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).
from skin incision till skin closure
The operative time is recorded in minutes
Time Frame: from skin incision till skin closure
The operative time is recorded in minutes
from skin incision till skin closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2017

Primary Completion (ANTICIPATED)

March 1, 2018

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

December 10, 2017

First Submitted That Met QC Criteria

December 13, 2017

First Posted (ACTUAL)

December 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2017

Last Update Submitted That Met QC Criteria

December 13, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 336695

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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