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| Name | Class |
|---|---|
| Randers Regional Hospital | OTHER |
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The aim of this trial was to compare two different uterotomy surgical techniques on the occurrence of a uterine niche and the risk of a number of short- and long-term gynecological complications associated with the presence and size of the niche.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional technique | Active Comparator | Closure of the uterotomy with a conventional two-layer technique |
|
| Modified technique | Experimental | Closure of the uterotomy with a modified two-layer technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional | Procedure | Two-layer technique with the first layer performed as an un-locked, continuous suture without inclusion of the endometrium and the second layer performed as an un-locked, continuous suture with the stitches placed superficially, horizontally along the first layer. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of a cesarean scar niche more than 2 mm deep. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Residual myometrial thickness of the cesarean scar (RMT) | 6 months | |
| Cesarean scar niche depth, width, length, myometrium adjacent to the scar | 6 months | |
| Post-menstrual spotting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Uldbjerg, MD, DMSc | Aarhus University Hospital | Study Chair |
| Lone Hvidman, MD, PhD | Aarhus University Hospital | Study Chair |
| Axel Forman, MD, DMSc | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. Obstetrics and Gynecology, Regional Hospital of Randers | Randers | 8930 | Denmark |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| Modified | Procedure | The modified mattress suture is performed as a single-suture, double-layer technique with limited inclusion of the myometrium and broad inclusion of the serosal surface and myometrium, interchangeably |
|
| 15 months |
| Incidence of cesarean scar pregnancy or spontaneous abortions | 72 months |
| Adverse pregnancy outcomes in the following pregnancy | Composite of placenta previa, placenta accreta or percreta, uterine rupture or dehiscence | 72 months |