Digital Cervical and Cesarean Section

Caesarean Section Clinical Trial

Official title:

The Role of Digital Cervical Opening in Elective Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392077
• Other study ID #: DCCS
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 1, 2019
• Est. primary completion date: January 1, 2019
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Caesarean Section

Intervention

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
• No cervical dilatation
after delivery of the baby cervix will be remain closed

Locations

Country	Name	City	State
Egypt	Woman's Health Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of postpartum blood loss (ml)		24 hours