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

NCT05997498 | Unknown

• 1 other identifier: Mechanical Dilatation CS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the effects of cervical dilatation during cesarean section on postoperative maternal morbidity through different clinical parameters.

Conditions

Cesarean Section Complications

Keywords

Cesarean Section; Mechanical Dilatation

Outcome Measures

Primary Outcomes (1)

• postpartum 6th month scar thickness

  measure the thickness of the residual myometrial tissue (RMT) in mm by transvaginal ultrsound

  6 months after delivery

Study Arms (2)

dilation group

EXPERIMENTAL

mechanical cervical dilatation will be done.

Procedure: mechanical cervical dilatation

control

NO INTERVENTION

in which no mechanical cervical dilatation will be done.

Interventions

mechanical cervical dilatation PROCEDURE

mechanical cervical dilatation during elective cesarean section

dilation group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Elective Cs (primary or repeated CS)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

Central Study Contacts

Salem

CONTACT

01272842226; sara_abdallah100@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 18, 2023
• Study Start: August 30, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 20, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

EG (1)