Digital Cervical and Cesarean Section

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03392077
Collaborator
(none)
300
1
13
23.1

Study Details

Study Description

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 Phase
  • Procedure: Caesarean section
  • Other: cervical dilatation
  • Other: No cervical dilatation

Study Design

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 :
Jan 1, 2018
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. The amount of postpartum blood loss (ml) [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
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

Locations

Site City State Country Postal Code
1 Woman's Health Hospital Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Khairy Ali, Lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT03392077
Other Study ID Numbers:
  • DCCS
First Posted:
Jan 5, 2018
Last Update Posted:
Sep 24, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 24, 2019