ClinicalTrials.gg
CompletedNCT03392077Updated Sep 24, 2019

Digital Cervical and Cesarean Section

An observational study in Caesarean Section, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-09-24.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
300
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Caesarean Section
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

women who will subjected to elective Cesarean section

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • Group A: cervical dilatation

    patients who will have cervical dilatation during Caesarean section

    Procedure: Caesarean section · Other: cervical dilatation

  • Group A: non cervical dilatation

    patients who will have not cervical dilatation during Caesarean section

    Procedure: Caesarean section · Other: No cervical dilatation

Interventions

  • ProcedureCaesarean section

    Caesarean section will be done to deliver the baby

  • Othercervical dilatation

    Cervical dilatation will be done by double gloves digital dilatation postpartum

  • OtherNo cervical dilatation

    after delivery of the baby cervix will be remain closed

06

What researchers measure

Primary outcomes

  1. The amount of postpartum blood loss (ml)

    Time frame: 24 hours

07

Study locations

1 site
  • Woman's Health Hospital
    Asyut, 71111, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03392077
Lead sponsor
Assiut University
Responsible party
Mohammed Khairy Ali (Lecturer, Assiut University) — Principal investigator
First posted
Jan 5, 2018
Start date
Jan 1, 2018
Primary completion
Jan 1, 2019
Completion
Feb 1, 2019
Last update
Sep 24, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion