Intracervical Vasopressin

Prisma Health-Upstate

Status and phase: Enrolling; Phase 4

Conditions: Retained Products of Conception

Treatments: Drug: Intracervical Injection of saline; Drug: Intracervical injection of Vasopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT07102615

2269142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 51 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

Vasopressin- 20 mL of a dilute solution (5 units of Vasopressin in 20cc injectable saline)

Treatment:

Drug: Intracervical injection of Vasopressin

Placebo

Placebo Comparator group

Description:

20 mL of saline

Treatment:

Drug: Intracervical Injection of saline