Cesarean Section ComplicationsNCT05997498
Mechanical Dilatation of the Cervix at Elective Caesarean Section on Post-operative Morbidity
A study testing mechanical cervical dilatation in people with Cesarean Section Complications, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The study aims to evaluate the effects of cervical dilatation during cesarean section on postoperative maternal morbidity through different clinical parameters. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- mechanical cervical dilatation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2023to 20 Feb 2024
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Elective Cs (primary or repeated CS)
Who cannot join
- Medical or obstetric conditions that may put them at risk for uterine atony and postpartum hemorrhage and infection, such as:
- Emergency Cesarean section
- Chorioamnionitis.
- Preterm caesarean section.
- Multiple gestations.
- Fever during admission.
- Rupture of membranes.
- Anemia
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
Official title: The Effect of Mechanical Dilatation of the Cervix at Elective Caesarean Section on Post-operative Morbidity
The study aims to evaluate the effects of cervical dilatation during cesarean section on postoperative maternal morbidity through different clinical parameters.
Read the detailed description
A randomized double-blind clinical trial comparing cervical dilatation during caesarean section to no intervention.
- Study participants and sample size This study will include pregnant women with a singleton fetus at term ≥37 weeks of gestation and will be scheduled for elective caesarean section. Eligible participants will be allocated either to the study group (women with intraoperative cervical dilatation) or the control group (women with no intraoperative cervical dilatation).
- Types of interventions Mechanical dilatation of the cervix using a finger, sponge forceps during non-labour caesarean section ***Randomization and Allocation A statistician prepared a computer-generated random tableand placed the group allocation in serially numbered closed opaque envelopes in a 1:1 ratio. Packing, sealing and numbering will be performed by two independent doctors other than the investigator.
Patients are allocated to either study group (cervical dilatation) or control group (no cervical dilatation). Allocation will be never changed after opening the envelopes. All patients are blinded to the allocation to avoid bias.
**Neither the investigator nor the outcome assessor following up the patient postoperatively are aware whether the patient had undergone cervical dilation during the cesarean section or not (double-blinding). Randomization coding tables will be hidden from the investigator till the end of the study.
Group I (dilation group): in which mechanical cervical dilatation will be done.
Group II (Non-dilation group): in which no mechanical cervical dilatation will be done. * ***Study procedure:
After taking informed written consent, the recruited patients will be subjected to the following:
Clinical examination:
- History: personal (age, duration of marriage), present (any current medical or surgical diseases and any current medication), Past (history of any medical disorder) and obstetric history (including Parity, Gestational age, obstetric complications). Indications for cesarean were determined as malposition of the fetal head, head-pelvis incompatibility, disrupted fetal heart rate.
- General examination: assessment of body mass index (BMI) ,vital data (pulse, blood pressure, temperature), cardiac and chest auscultation to exclude contraindications for anesthesia.
- Abdominal examination: assessment of fundal level, fetal lie and presentation liquor volume and previous scar if present.
- Vaginal examination: to exclude cervical changes.
- Ultrasound examination: to assess fetal viability, determine gestational age and exclude major anomalies.
Steps:
- Informed consent will be obtained from women who will be invited to participate in the research after an explanation of the benefits and risks of this trial.
- All caesarean sections will be performed by a senior registrar capable of doing uncomplicated elective cesarean sections.
- Conditions
- Cesarean Section Complications
- Being tested
- mechanical cervical dilatation
- Keywords
- Cesarean Section, Mechanical Dilatation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical cervical dilatationProcedure or surgery
mechanical cervical dilatation during elective cesarean section
| Study group | Role | What they receive |
|---|---|---|
| dilation group | Experimental | mechanical cervical dilatation will be done. Receives: Procedure: mechanical cervical dilatation |
| control | No intervention | in which no mechanical cervical dilatation will be done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpartum 6th month scar thickness
measure the thickness of the residual myometrial tissue (RMT) in mm by transvaginal ultrsound
Measured: 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start30 Aug 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997498
- Sponsor's protocol ID
- Mechanical Dilatation CS
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mechanical Dilatation of the Cervix at Elective Caesarean Section on Post-operative Morbidity
- ClinicalTrials.gov ID
- NCT05997498
- Acronym / sponsor ID
- Mechanical Dilatation CS
- Conditions
- Cesarean Section Complications
- Keywords
- Cesarean Section, Mechanical Dilatation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 18 Aug 2023 (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.
The study aims to evaluate the effects of cervical dilatation during cesarean section on postoperative maternal morbidity through different clinical parameters.
Detailed description
A randomized double-blind clinical trial comparing cervical dilatation during caesarean section to no intervention.
- Study participants and sample size This study will include pregnant women with a singleton fetus at term ≥37 weeks of gestation and will be scheduled for elective caesarean section. Eligible participants will be allocated either to the study group (women with intraoperative cervical dilatation) or the control group (women with no intraoperative cervical dilatation).
- Types of interventions Mechanical dilatation of the cervix using a finger, sponge forceps during non-labour caesarean section ***Randomization and Allocation A statistician prepared a computer-generated random tableand placed the group allocation in serially numbered closed opaque envelopes in a 1:1 ratio. Packing, sealing and numbering will be performed by two independent doctors other than the investigator.
Patients are allocated to either study group (cervical dilatation) or control group (no cervical dilatation). Allocation will be never changed after opening the envelopes. All patients are blinded to the allocation to avoid bias.
**Neither the investigator nor the outcome assessor following up the patient postoperatively are aware whether the patient had undergone cervical dilation during the cesarean section or not (double-blinding). Randomization coding tables will be hidden from the investigator till the end of the study.
Group I (dilation group): in which mechanical cervical dilatation will be done.
Group II (Non-dilation group): in which no mechanical cervical dilatation will be done. * ***Study procedure:
After taking informed written consent, the recruited patients will be subjected to the following:
Clinical examination:
- History: personal (age, duration of marriage), present (any current medical or surgical diseases and any current medication), Past (history of any medical disorder) and obstetric history (including Parity, Gestational age, obstetric complications). Indications for cesarean were determined as malposition of the fetal head, head-pelvis incompatibility, disrupted fetal heart rate.
- General examination: assessment of body mass index (BMI) ,vital data (pulse, blood pressure, temperature), cardiac and chest auscultation to exclude contraindications for anesthesia.
- Abdominal examination: assessment of fundal level, fetal lie and presentation liquor volume and previous scar if present.
- Vaginal examination: to exclude cervical changes.
- Ultrasound examination: to assess fetal viability, determine gestational age and exclude major anomalies.
Steps:
- Informed consent will be obtained from women who will be invited to participate in the research after an explanation of the benefits and risks of this trial.
- All caesarean sections will be performed by a senior registrar capable of doing uncomplicated elective cesarean sections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dilation group | Experimental | Procedure: mechanical cervical dilatationmechanical cervical dilatation will be done. |
| control | No intervention | –in which no mechanical cervical dilatation will be done. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Elective Cs (primary or repeated CS)
Key exclusion criteria (8 listed)
- Medical or obstetric conditions that may put them at risk for uterine atony and postpartum hemorrhage and infection, such as:
- Emergency Cesarean section
- Chorioamnionitis.
- Preterm caesarean section.
- Multiple gestations.
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 |
|---|---|---|
| mechanical cervical dilatationmechanical cervical dilatation during elective cesarean section | Procedure or surgery | dilation group |
Primary outcome
postpartum 6th month scar thickness
Time frame: 6 months after delivery
measure the thickness of the residual myometrial tissue (RMT) in mm by transvaginal ultrsound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: Yes
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical cervical dilatation in people with Cesarean Section Complications, run by Beni-Suef 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salem (01272842226 ext. 02, sara_abdallah100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postpartum 6th month scar thickness (time frame: 6 months after delivery). 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 18 Aug 2023.