Recruiting

Intracervical Vasopressin for Hysteroscopic Removal of Retained Conception Products

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What is being tested

Intracervical injection of Vasopressin

+ Intracervical Injection of saline
Drug
Who is being recruted

Retained Products of Conception

From 18 to 51 Years
+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 4
Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorPrisma Health-Upstate
Study ContactPatti Parker, BSN
Last updated: November 4, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 30, 2025Actual date on which the first participant was enrolled.

This study focuses on improving the safety and effectiveness of a procedure used to remove retained products of conception, which can occur after childbirth or miscarriage. The research targets individuals undergoing hysteroscopic surgery, a common method for this removal. Researchers are evaluating whether an injection of a drug called vasopressin into the cervix can help complete the procedure more successfully without needing to switch to a different method due to complications like excessive bleeding. This study is important as it could enhance surgical outcomes and reduce the need for additional interventions during this procedure. Participants in this study will be randomly assigned to receive either the vasopressin injection or a placebo during their hysteroscopic surgery. The main goal is to determine if the use of vasopressin helps to complete the surgery without switching methods. Researchers will assess the surgery's success by monitoring factors like the amount of bleeding, how long the surgery takes, and the volume of fluid used. This information will help determine the effectiveness and safety of using vasopressin in this context.

Official TitleIntracervical Vasopressin for Completion of Hysteroscopic Removal of Retained Products of Conception 
Principal SponsorPrisma Health-Upstate
Study ContactPatti Parker, BSN
Last updated: November 4, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 51 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Retained Products of Conception
Criteria
3 inclusion criteria required to participate
Women
Aged 18-51
Undergoing surgical management for retained products of conception, postpartum retained products of conception or 1st trimester missed or incomplete abortion
5 exclusion criteria prevent from participating
Hemodynamic instability
Active hemorrhage- soaking pad/hour
Allergy to vasopressin
Concern for intrauterine arteriovenous malformation

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Active Comparator
Vasopressin- 20 mL of a dilute solution (5 units of Vasopressin in 20cc injectable saline)
Group II
Placebo
20 mL of saline
Study Objectives
Primary Objectives

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

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 from insertion of hysteroscope to procedure completion

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
The OB/GYN CenterGreenville, United StatesSee the location
Recruiting
One Study Center