Intracervical Vasopressin

Not Applicable

Not yet recruiting

• Conditions: Retained Products of Conception
• Interventions: Drug: Intracervical injection of Vasopressin; Drug: Intracervical Injection of saline

• Registration Number: NCT07102615
• Lead Sponsor: Prisma Health-Upstate

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-07-31
• Last Update Submitted: 2025-07-31
• Study Start: 2025-08-04
• Study First Posted: 2025-08-04
• Last Update Posted: 2025-08-04
• Primary Completion: 2026-08-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Intracervical injection of Vasopressin	Vasopressin- 20 mL of a dilute solution (5 units of Vasopressin in 20cc injectable saline)
Placebo	Intracervical Injection of saline	20 mL of saline

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.