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Status unknownNCT03377894Updated Dec 19, 2017

Sharp Versus Blunt Uterine Incision Expansion

A Phase 2/3 interventional study of blunt uterine incision expansion and sharp uterine incision expansion in Cesarean Section Complications, sponsored by Kasr El Aini Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 37 Years. Per ClinicalTrials.gov, last updated 2017-12-19.

Sponsored by Kasr El Aini Hospital · Phase 2/3, Interventional, and Other

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
20 Years to 37 Years
Sex
Female
01

Study 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

Read the 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
02

Conditions studied

  • Cesarean Section Complications
03

Who can participate

Ages eligible
20 Years to 37 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • singleton pregnancy.

Exclusion criteria

Exclusion Criteria:

  • previous PID
  • any medical or psychiatric
  • patients with BMI ≥ 40
  • multigravidas
  • chronic analgesia use,
  • allergy to analgesics,
  • multiple pregnancies are also excluded
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Procedureblunt uterine incision expansion

    blunt uterine incision expansion

  • Proceduresharp uterine incision expansion

    sharp uterine incision expansion

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: one hour after cs

  2. 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).

    Time frame: from skin incision till skin closure

  3. The operative time is recorded in minutes

    The operative time is recorded in minutes

    Time frame: from skin incision till skin closure

06

Study locations

1 site
  • Kasr El Ainiy Hospital
    Cairo, 11562, Egypt
07

Registry details

Key details

Study ID
NCT03377894
Lead sponsor
Kasr El Aini Hospital
Responsible party
sarah mohamed hassan (lecturer of obstetrics and gynecology, Kasr El Aini Hospital) — Principal investigator
First posted
Dec 19, 2017
Start date
Dec 2017 (estimated)
Primary completion
Mar 2018 (estimated)
Completion
Mar 2018 (estimated)
Last update
Dec 19, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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