Clinical trial NCT05997498: Mechanical Dilatation of the Cervix at Elective Caesarean Section on Post-operative Morbidity
Official title: The Effect of Mechanical Dilatation of the Cervix at Elective Caesarean Section on Post-operative Morbidity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Section Complications
Keywords: Cesarean Section
Mechanical Dilatation
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: postpartum 6th month scar thickness
timeFrame: 6 months after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
state: Beni Suef
Study officials:
References: