Intracervical Vasopressin

NCT ID: NCT07102615

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2026-12-01

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.

Conditions

Retained Products of Conception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: ACTIVE_COMPARATOR

Intracervical injection of Vasopressin

Intervention Type: DRUG

Intracervical injection of Vasopressin

Placebo

20 mL of saline

Group Type: PLACEBO_COMPARATOR

Intracervical Injection of saline

Intervention Type: DRUG

Intracervical Injection of saline

Interventions

Intracervical injection of Vasopressin

Intracervical injection of Vasopressin

Intervention Type: DRUG

Intracervical Injection of saline

Intracervical Injection of saline

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prisma Health-Upstate

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Miller, MD

Role: STUDY_DIRECTOR

Prisma Health

Locations

The OB/GYN Center

Greenville, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Patti Parker, BSN

Role: CONTACT

patti.parker@prismahealth.org

864-455-1510

Paul Miller, MD

Role: CONTACT

paul.miller@prismahealth.org

894-455-1600

Facility Contacts

Erica Lowing, MD

Role: primary

erica.lowing@prismahealth.org

864-455-1600

Other Identifiers

2269142

Identifier Type: -

Identifier Source: org_study_id