Sharp Versus Blunt Uterine Incision Expansion

NCT ID: NCT03377894

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2018-03-31

Brief Summary

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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

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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

Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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• 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

Group Type ACTIVE_COMPARATOR

blunt uterine incision expansion

Intervention Type PROCEDURE

blunt uterine incision expansion

• 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

Group Type ACTIVE_COMPARATOR

sharp uterine incision expansion

Intervention Type PROCEDURE

sharp uterine incision expansion

Interventions

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blunt uterine incision expansion

blunt uterine incision expansion

Intervention Type PROCEDURE

sharp uterine incision expansion

sharp uterine incision expansion

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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sarah mohamed hassan

lecturer of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr El Ainiy Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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336695

Identifier Type: -

Identifier Source: org_study_id