Digital Cervical and Cesarean Section

September 22, 2019 updated by: Mohammed Khairy Ali, Assiut University

The Role of Digital Cervical Opening in Elective Cesarean Section

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

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
      • Assiut, Egypt, 71111
        • Woman's Health 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

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women who will subjected to elective Cesarean section

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A: cervical dilatation
patients who will have cervical dilatation during Caesarean section
Procedure: Caesarean section
Caesarean section will be done to deliver the baby
Other: cervical dilatation
Cervical dilatation will be done by double gloves digital dilatation postpartum
Group A: non cervical dilatation
patients who will have not cervical dilatation during Caesarean section
Procedure: Caesarean section
Caesarean section will be done to deliver the baby
Other: No cervical dilatation
after delivery of the baby cervix will be remain closed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The amount of postpartum blood loss (ml)
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Assiut University

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 (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 2, 2018

First Posted (ACTUAL)

January 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 22, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • DCCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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