Digital Cervical and Cesarean Section

Completed

• Conditions: Caesarean Section
• Interventions: Procedure: Caesarean section; Other: cervical dilatation; Other: No cervical dilatation

• Registration Number: NCT03392077
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-05
• Primary Completion: 2019-01-01
• Study Completion: 2019-02-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-22
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A: non cervical dilatation	Caesarean section	patients who will have not cervical dilatation during Caesarean section
Group A: cervical dilatation	cervical dilatation	patients who will have cervical dilatation during Caesarean section
Group A: cervical dilatation	Caesarean section	patients who will have cervical dilatation during Caesarean section
Group A: non cervical dilatation	No cervical dilatation	patients who will have not cervical dilatation during Caesarean section

Primary Outcome Measures

Name	Time	Method
The amount of postpartum blood loss (ml)	24 hours

Trial Locations

Locations (1)

Woman's Health Hospital; 🇪🇬 Assiut, Egypt