Intracervical Vasopressin
ConditionRetained Products of Conception
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-51
SponsorPrisma Health-Upstate
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women
Aged 18-51
Undergoing surgical management for retained products of conception, postpartum retained products of conception or 1st trimester missed or incomplete abortion
Disqualifiers
Hemodynamic instability
Active hemorrhage- soaking pad/hour
Allergy to vasopressin
Concern for intrauterine arteriovenous malformation
Trial design
Design model
Parallel
Treatments tested in this trial
Intracervical injection of Vasopressin
DrugIntracervical injection of Vasopressin
Intracervical Injection of saline
DrugIntracervical Injection of saline
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: TreatmentActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Completion of procedure hysteroscopically
There is complete removal of RPOC hysteroscopically by the end of the procedure.
Time frame
from start of procedure to end of procedureSecondary outcomes
1
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
Time frame
from start of procedure to end of procedure2
Operative time
time from insertion of hysteroscope to procedure completion
Time frame
time from insertion of hysteroscope to procedure completion3
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.
Time frame
from start of procedure to end of procedureSponsors and contacts
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Source ClinicalTrials.gov