Intracervical Vasopressin

NCT07102615 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2269142
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Retained Products of Conception

Keywords

retained products of conception; intracervical; hysteroscopy

Outcome Measures

Primary Outcomes (1)

• Completion of procedure hysteroscopically

  There is complete removal of RPOC hysteroscopically by the end of the procedure.

  from start of procedure to end of procedure

Secondary Outcomes (3)

• Intraoperative Bleeding

  from start of procedure to end of procedure

• Operative time

  time from insertion of hysteroscope to procedure completion

• fluid deficit volume

  from start of procedure to end of procedure

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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

Drug: Intracervical injection of Vasopressin

Placebo

PLACEBO COMPARATOR

20 mL of saline

Drug: Intracervical Injection of saline

Interventions

Intracervical injection of Vasopressin DRUG

Intracervical injection of Vasopressin

Treatment

Intracervical Injection of saline DRUG

Intracervical Injection of saline

Placebo

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women
• Aged 18-51
• Undergoing surgical management for retained products of conception, postpartum retained products of conception or 1st trimester missed or incomplete abortion

You may not qualify if:

• Hemodynamic instability
• Active hemorrhage- soaking pad/hour
• Allergy to vasopressin
• Concern for intrauterine arteriovenous malformation
• Inability to consent

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

The OB/GYN Center

Greenville, South Carolina, 29605, United States

RECRUITING

Study Officials

• Paul Miller, MD

  Prisma Health

  STUDY DIRECTOR

Central Study Contacts

Patti Parker, BSN

CONTACT

864-455-1510; patti.parker@prismahealth.org

Paul Miller, MD

CONTACT

894-455-1600; paul.miller@prismahealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 4, 2025
• Study Start: October 30, 2025
• Primary Completion: August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)