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Digital Cervical and Cesarean Section

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: NCT03392077
Recruitment Status : Completed
First Posted : January 5, 2018
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Caesarean Section Procedure: Caesarean section Other: cervical dilatation Other: No cervical dilatation

Study Design
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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Role of Digital Cervical Opening in Elective Cesarean Section
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. The amount of postpartum blood loss (ml) [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
women who will subjected to elective Cesarean section
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03392077


Locations
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Egypt
Woman's Health Hospital
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Mohammed Khairy Ali, Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03392077    
Other Study ID Numbers: DCCS
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No