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This randomized study looks at whether using a medicine injected into the cervix of the uterus (intracervical), called vasopressin, helps to achieve better removal of retained products of conception (RPOC). RPOC means that after a pregnancy has ended (through miscarriage, abortion, or delivery), some parts of the pregnancy tissue, usually from the placenta or fetus, have stayed in the uterus. A hysteroscopic removal of RPOC is one type of treatment. This is a surgical procedure where a doctor uses a small camera attached to a thin tube (called a hysteroscope) to look inside the uterus.
The main goal of the study is :
• To add to the existing research through this study to see if the injection of intracervical vasopressin leads to improved completion rates of hysteroscopic management of RPOC.
Participants will:
• would be randomized to receive either vasopressin intracervical injection or a placebo injection (non-active saline) during your procedure. Information from the procedure will be collected from the participant's medical record.
This double-blinded randomized control trial is designed to evaluate if intraoperative injection of intracervical vasopressin into the cervix will allow for completion of hysteroscopic removal of retained products of conception. This will be measured by surgical completion comparing patients who received intracervical vasopressin and those receiving placebo. Surgical completion is defined by completing the procedure without having to convert to suction of tissue due to bleeding or poor visualization. Secondary outcome measures include intraoperative bleeding, operative time, fluid deficit, and deficit volume.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | Vasopressin- 20 mL of a dilute solution (5 units of Vasopressin in 20cc injectable saline) |
|
| Placebo | Placebo Comparator | 20 mL of saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracervical injection of Vasopressin | Drug | Intracervical injection of Vasopressin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of procedure hysteroscopically | There is complete removal of RPOC hysteroscopically by the end of the procedure. | from start of procedure to end of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Bleeding | calculated by dividing the number of red blood cells per milliliter of outflow distention fluid by the number of red blood cells per milliliter of the woman's blood immediately before the procedure and multiplying this quotient by the total amount of outflow fluid collected | from start of procedure to end of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patti Parker, BSN | Contact | 864-455-1510 | patti.parker@prismahealth.org | |
| Paul Miller, MD | Contact | 894-455-1600 | paul.miller@prismahealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Paul Miller, MD | Prisma Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The OB/GYN Center | Recruiting | Greenville | South Carolina | 29605 | United States |
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| Intracervical Injection of saline |
| Drug |
Intracervical Injection of saline |
|
| Operative time | time from insertion of hysteroscope to procedure completion | time from insertion of hysteroscope to procedure completion |
| fluid deficit volume | The difference between the total volume of distension fluid infusion into the uterine cavity during the hysteroscopy and the volume of fluid recovered from the outflow. | from start of procedure to end of procedure |