Mechanical Dilatation of the Cervix at Elective Caesarean Section on Post-operative Morbidity

NCT ID: NCT05997498

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2024-02-20

Brief Summary

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.

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

dilation group

mechanical cervical dilatation will be done.

Group Type: EXPERIMENTAL

mechanical cervical dilatation

Intervention Type: PROCEDURE

mechanical cervical dilatation during elective cesarean section

control

in which no mechanical cervical dilatation will be done.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mechanical cervical dilatation

mechanical cervical dilatation during elective cesarean section

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Elective Cs (primary or repeated CS)

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Sara Abdallah Mohamed Salem

principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Countries

Egypt

Central Contacts

Salem

Role: CONTACT

sara_abdallah100@yahoo.com

01272842226 ext. 02

Other Identifiers

Mechanical Dilatation CS

Identifier Type: -

Identifier Source: org_study_id