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Clinical Trials/NCT03392077
NCT03392077CompletedNot Applicable

The Role of Digital Cervical Opening in Elective Cesarean Section

Assiut University1 site in 1 country300 target enrollmentStarted: January 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
300
Locations
1
Primary Endpoint
The amount of postpartum blood loss (ml)

Study Overview

Brief Summary

Cesarean delivery is one of the most commonly performed surgical operations worldwide Cesarean delivery even as an elective procedure has been associated with considerable maternal risks compared with vaginal delivery. Some of the complications include postpartum hemorrhage, uterine infection, urinary tract infection, wound infection, septicemia and maternal death. Over the years, many variations in the surgical technique of Cesarean delivery have been employed with the main purpose of improving its safety. A woman's cervix is firm and undilated at the beginning of pregnancy, but progressive remodeling occurs during gestation until the cervix is soft at term, especially the nulliparous cervix . The progressive dilatation of the cervix needs uterine contraction during labor. A mechanical dilatation of the cervix at cesarean section is defined as an artificial dilatation of the cervix performed by finger, sponge forceps or other instruments at non-labor cesarean section. According to a cochrane view The information currently available about the advantages of cervical dilatation at cesarean section is inconclusive. This may be due to small sample sizes and low power of statistic.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All women scheduled for elective cesarean section will be approached.
  • Women accepted to participate in the study participation after discussing the nature of the study.

Exclusion Criteria

  • Immuno-compromised women.
  • Women suffering from any coagulation disorder or Blood disease.
  • Blood transfusion during surgery or before it.
  • History of wound infection or endometritis .
  • Ante partum hemorrhage.
  • History of long corticosteroid use.
  • Women refuse to participate in the study.
  • Suspected clinical evidence of infection.
  • anemic women
  • Multiple pregnancy
  • Preterm births
  • Rupture of membranes or chorioamnionitis
  • Women who use antibiotics during the last 24 hours due to any infection but not prophylactic antibiotic during caesarian section
  • Emergency caesarean section

Outcomes

Primary Outcomes

The amount of postpartum blood loss (ml)

Time Frame: 24 hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohammed Khairy Ali

Lecturer

Assiut University

Study Sites (1)

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