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Sharp Versus Blunt Uterine Incision Expansion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377894
Recruitment Status : Unknown
Verified December 2017 by sarah mohamed hassan, Kasr El Aini Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
sarah mohamed hassan, Kasr El Aini Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Procedure: blunt uterine incision expansion Procedure: sharp uterine incision expansion Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
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
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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).


  3. The operative time is recorded in minutes [ Time Frame: from skin incision till skin closure ]
    The operative time is recorded in minutes


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377894


Locations
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Egypt
Kasr El Ainiy Hospital
Cairo, Egypt, 11562
Sponsors and Collaborators
Kasr El Aini Hospital
More Information
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Responsible Party: sarah mohamed hassan, lecturer of obstetrics and gynecology, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03377894    
Other Study ID Numbers: 336695
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries