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The study aims to evaluate the effects of cervical dilatation during cesarean section on postoperative maternal morbidity through different clinical parameters.
A randomized double-blind clinical trial comparing cervical dilatation during caesarean section to no intervention.
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:
Steps:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dilation group | Experimental | mechanical cervical dilatation will be done. |
|
| control | No Intervention | in which no mechanical cervical dilatation will be done. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mechanical cervical dilatation | Procedure | mechanical cervical dilatation during elective cesarean section |
|
| Measure | Description | Time Frame |
|---|---|---|
| postpartum 6th month scar thickness | measure the thickness of the residual myometrial tissue (RMT) in mm by transvaginal ultrsound | 6 months after delivery |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salem | Contact | 01272842226 | 02 | sara_abdallah100@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-suef university Hospital | Banī Suwayf | Beni Suweif Governorate | 62521 | Egypt |
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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.