Retained Products of ConceptionPhase 4NCT07102615
Intracervical Vasopressin
A Phase 4 study testing Intracervical injection of Vasopressin and Intracervical Injection of saline in people with Retained Products of Conception, run by Prisma Health-Upstate at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Retained Products of Conception
- What is being tested?
- Intracervical injection of Vasopressin and Intracervical Injection of saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women
- Aged 18-51
- Undergoing surgical management for retained products of conception, postpartum retained products of conception or 1st trimester missed or incomplete abortion
Who cannot join
- Hemodynamic instability
- Active hemorrhage- soaking pad/hour
- Allergy to vasopressin
- Concern for intrauterine arteriovenous malformation
- Inability to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The OB/GYN Center
Greenville, South Carolina, 29605
Erica Lowing, MD, 864-455-1600, erica.lowing@prismahealth.org
About this study
Official title: Intracervical Vasopressin for Completion of Hysteroscopic Removal of Retained Products of Conception
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 :
Read more
- 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.
Read the 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
- Being tested
- Intracervical injection of Vasopressin, Intracervical Injection of saline
- Keywords
- retained products of conception, intracervical, hysteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracervical injection of VasopressinDrug
Intracervical injection of Vasopressin
Intracervical Injection of salineDrug
Intracervical Injection of saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Vasopressin- 20 mL of a dilute solution (5 units of Vasopressin in 20cc injectable saline) Receives: Drug: Intracervical injection of Vasopressin |
| Placebo | Placebo comparator | 20 mL of saline Receives: Drug: Intracervical Injection of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of procedure hysteroscopically
There is complete removal of RPOC hysteroscopically by the end of the procedure.
Measured: from start of procedure to end of procedure
Secondary outcomes (3)
Intraoperative Bleeding
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
Measured: from start of procedure to end of procedure
Operative time
time from insertion of hysteroscope to procedure completion
Measured: time from insertion of hysteroscope to procedure completion
fluid deficit volume
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.
Measured: from start of procedure to end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2025
- Study start30 Oct 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained Products of ConceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Miller, MD, Study director, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102615
- Sponsor's protocol ID
- 2269142
- Status last verified
- Oct 2025
- First submitted
- 31 Jul 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracervical Vasopressin for Completion of Hysteroscopic Removal of Retained Products of Conception
- ClinicalTrials.gov ID
- NCT07102615
- Acronym / sponsor ID
- 2269142
- Conditions
- Retained Products of Conception
- Keywords
- retained products of conception, intracervical, hysteroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Intracervical injection of VasopressinVasopressin- 20 mL of a dilute solution (5 units of Vasopressin in 20cc injectable saline) |
| Placebo | Placebo comparator | Drug: Intracervical Injection of saline20 mL of saline |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women
- Aged 18-51
- Undergoing surgical management for retained products of conception, postpartum retained products of conception or 1st trimester missed or incomplete abortion
Key exclusion criteria (5 listed)
- Hemodynamic instability
- Active hemorrhage- soaking pad/hour
- Allergy to vasopressin
- Concern for intrauterine arteriovenous malformation
- Inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracervical injection of VasopressinIntracervical injection of Vasopressin | Drug | Treatment |
| Intracervical Injection of salineIntracervical Injection of saline | Drug | Placebo |
Primary outcome
Completion of procedure hysteroscopically
Time frame: from start of procedure to end of procedure
There is complete removal of RPOC hysteroscopically by the end of the procedure.
3 secondary outcomes
Intraoperative Bleeding
Time frame: from start of procedure to end of procedure
Operative time
Time frame: time from insertion of hysteroscope to procedure completion
fluid deficit volume
Time frame: from start of procedure to end of procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Retained Products of Conception
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
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Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
Retained Products of Conception
Recruiting
Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial
Retained Product of Conception After First Trimester Medical Abortion
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A Prospective Multicenter Observational Real-world Study of Retained Products of Conception
Retained Products of Conception, RPOC
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Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings
Fibroid Uterus, Polyp Uterus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Miller, MD study director
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intracervical injection of Vasopressin and Intracervical Injection of saline in people with Retained Products of Conception, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patti Parker, BSN (864-455-1510, patti.parker@prismahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of procedure hysteroscopically (time frame: from start of procedure to end of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.