Retained Products of Conception
Conditions
Keywords
retained products of conception, intracervical, hysteroscopy
Brief summary
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.
Detailed description
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.
Interventions
DRUGIntracervical injection of Vasopressin
Intracervical injection of Vasopressin
DRUGIntracervical Injection of saline
Intracervical Injection of saline
Sponsors
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 51 Years
Healthy volunteers
No
Inclusion criteria
* Women * Aged 18-51 * Undergoing surgical management for retained products of conception, postpartum retained products of conception or 1st trimester missed or incomplete abortion
Exclusion criteria
* Hemodynamic instability * Active hemorrhage- soaking pad/hour * Allergy to vasopressin * Concern for intrauterine arteriovenous malformation * Inability to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of procedure hysteroscopically | from start of procedure to end of procedure | There is complete removal of RPOC hysteroscopically by the end of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Bleeding | from start of procedure to end of procedure | 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 |
| Operative time | time from insertion of hysteroscope to procedure completion | time from insertion of hysteroscope to procedure completion |
| fluid deficit volume | from start of procedure to end of procedure | 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. |
Countries
United States
Contacts
Primary ContactPatti Parker, BSN
Backup ContactPaul Miller, MD
Outcome results
None listed