The OB/GYN Center
Greenville, South Carolina, 29605, United States
Location status: Recruiting
NCT Number: NCT07102615
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.
Interested in participating?
Request Info18 year–51 year
Female
Interventional
Phase 4
Greenville, South Carolina, 29605, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intracervical injection of Vasopressin
Intracervical Injection of saline
Time frame: from start of procedure to end of procedure
There is complete removal of RPOC hysteroscopically by the end of the procedure.
Time frame: 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
Time frame: time from insertion of hysteroscope to procedure completion
time from insertion of hysteroscope to procedure completion
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Patti Parker, BSN
CONTACT
Paul Miller, MD
CONTACT
Prisma Health-Upstate
Other
Intracervical Vasopressin for Completion of Hysteroscopic Removal of Retained Products of Conception
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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