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

August 15, 2023 updated by: Sara Abdallah Mohamed Salem, Beni-Suef University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Beni Suef
      • Banī Suwayf, Beni Suef, Egypt, 62521
        • Beni-suef university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dilation group
mechanical cervical dilatation will be done.
Procedure: mechanical cervical dilatation
mechanical cervical dilatation during elective cesarean section
No Intervention: control
in which no mechanical cervical dilatation will be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 30, 2023

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

February 20, 2024

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mechanical Dilatation CS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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