Caesarean SectionNCT03392077
Digital Cervical and Cesarean Section
An observational study of Caesarean Section, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Caesarean Section
- What is being tested?
- Caesarean section, cervical dilatation and No cervical dilatation
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: women who will subjected to elective Cesarean section
Who may be able to join
- All women scheduled for elective cesarean section will be approached.
- Women accepted to participate in the study participation after discussing the nature of the study.
Who cannot join
- Immuno-compromised women.
- Women suffering from any coagulation disorder or Blood disease.
- Blood transfusion during surgery or before it.
- History of wound infection or endometritis .
- Ante partum hemorrhage.
- History of long corticosteroid use.
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- Women refuse to participate in the study.
- Suspected clinical evidence of infection.
- anemic women
- Multiple pregnancy
- Preterm births
- Rupture of membranes or chorioamnionitis
- Women who use antibiotics during the last 24 hours due to any infection but not prophylactic antibiotic during caesarian section
- Emergency caesarean section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Digital Cervical Opening in Elective Cesarean Section
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.
- Conditions
- Caesarean Section
- Being tested
- Caesarean section, cervical dilatation, No cervical dilatation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caesarean sectionProcedure or surgery
Caesarean section will be done to deliver the baby
cervical dilatationOther
Cervical dilatation will be done by double gloves digital dilatation postpartum
No cervical dilatationOther
after delivery of the baby cervix will be remain closed
| Study group | Role | What they receive |
|---|---|---|
| Group A: cervical dilatation | patients who will have cervical dilatation during Caesarean section Receives: Procedure: Caesarean section; Other: cervical dilatation | |
| Group A: non cervical dilatation | patients who will have not cervical dilatation during Caesarean section Receives: Procedure: Caesarean section; Other: No cervical dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of postpartum blood loss (ml)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392077
- Sponsor's protocol ID
- DCCS
- Status last verified
- Sep 2019
- First submitted
- 2 Jan 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Digital Cervical Opening in Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT03392077
- Acronym / sponsor ID
- DCCS
- Conditions
- Caesarean Section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: cervical dilatation | – | Procedure: Caesarean section, Other: cervical dilatationpatients who will have cervical dilatation during Caesarean section |
| Group A: non cervical dilatation | – | Procedure: Caesarean section, Other: No cervical dilatationpatients who will have not cervical dilatation during Caesarean section |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- women who will subjected to elective Cesarean section
Key inclusion criteria (2 listed)
- All women scheduled for elective cesarean section will be approached.
- Women accepted to participate in the study participation after discussing the nature of the study.
Key exclusion criteria (14 listed)
- Immuno-compromised women.
- Women suffering from any coagulation disorder or Blood disease.
- Blood transfusion during surgery or before it.
- History of wound infection or endometritis .
- Ante partum hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caesarean sectionCaesarean section will be done to deliver the baby | Procedure or surgery | Group A: cervical dilatation, Group A: non cervical dilatation |
| cervical dilatationCervical dilatation will be done by double gloves digital dilatation postpartum | Other | Group A: cervical dilatation |
| No cervical dilatationafter delivery of the baby cervix will be remain closed | Other | Group A: non cervical dilatation |
Primary outcome
The amount of postpartum blood loss (ml)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caesarean Section, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of postpartum blood loss (ml) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.