HemorrhagePhase 2NCT06141447
Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation
A Phase 2 study testing Oxytocin + normal saline and Normal saline in people with Hemorrhage, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D\&E) in the clinic setting. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Oxytocin + normal saline and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2024to 2 Nov 2026
- Phase
- Phase 2
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- clinic-based D\&E at 18 weeks gestational age and above
- speaks English or Spanish
Who cannot join
- refuses IV
- history of coagulopathy
- anticoagulant use in the preceding five days
- chorioamnionitis or sepsis
- suspected placenta accreta spectrum
- intrauterine fetal demise
- multiple gestation
- use of misoprostol for cervical preparation
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
Comprehensive Women's Health Center
Denver, Colorado, 80230
Megan Masten, MD
About this study
Official title: Changes in Rate of Hemorrhage With Prophylactic Oxytocin for Second Trimester Dilation and Evacuation in the Clinic Setting
The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D\&E) in the clinic setting.
- Conditions
- Hemorrhage
- Being tested
- Oxytocin + normal saline, Normal saline
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin + normal salineDrug
40 units IV oxytocin once in a 1000 mL bag of normal saline
Normal salineDrug
1000 mL bag of normal saline alone
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Participants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D\&E. Receives: Drug: Oxytocin + normal saline |
| Placebo | Placebo comparator | Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D\&E. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhage
Quantitative blood loss greater than or equal to 500 mL or a clinical response to excessive bleeding such as transfusion or hospital admission
Measured: day of procedure
Quantitative blood loss
Measured blood loss during procedure
Measured: day of procedure
Secondary outcomes (1)
Procedure time
Length of time of total procedure and length of time until bleeding initially managed
Measured: day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start2 May 2024
- Primary completion2 Nov 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial - randomized to either receive treatment (40 units IV oxytocin + 1000 mL normal saline) or placebo (1000 mL normal saline alone).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141447
- Sponsor's protocol ID
- 23-2237
- Status last verified
- Dec 2024
- First submitted
- 15 Nov 2023
- Last updated
- 10 Dec 2024
- Results posted
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Rate of Hemorrhage With Prophylactic Oxytocin for Second Trimester Dilation and Evacuation in the Clinic Setting
- ClinicalTrials.gov ID
- NCT06141447
- Acronym / sponsor ID
- 23-2237
- Conditions
- Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 21 Nov 2023 (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.
The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D\&E) in the clinic setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial - randomized to either receive treatment (40 units IV oxytocin + 1000 mL normal saline) or placebo (1000 mL normal saline alone).
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: Oxytocin + normal salineParticipants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D\&E. |
| Placebo | Placebo comparator | Drug: Normal salineParticipants receive 1000 mL of normal saline alone at the time of tenaculum placement for D\&E. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- clinic-based D\&E at 18 weeks gestational age and above
- speaks English or Spanish
Key exclusion criteria (8 listed)
- refuses IV
- history of coagulopathy
- anticoagulant use in the preceding five days
- chorioamnionitis or sepsis
- suspected placenta accreta spectrum
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 |
|---|---|---|
| Oxytocin + normal saline40 units IV oxytocin once in a 1000 mL bag of normal saline | Drug | Oxytocin |
| Normal saline1000 mL bag of normal saline alone | Drug | Placebo |
Primary outcome
Hemorrhage
Time frame: day of procedure
Quantitative blood loss greater than or equal to 500 mL or a clinical response to excessive bleeding such as transfusion or hospital admission
Quantitative blood loss
Time frame: day of procedure
Measured blood loss during procedure
1 secondary outcome
Procedure time
Time frame: day 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 10 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin + normal saline and Normal saline in people with Hemorrhage, run by University of Colorado, Denver 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 2 inclusion and 8 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 10 Dec 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Megan Masten, MD (303-724-8576, megan.masten@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhage (time frame: day of procedure). The study lists 2 primary outcomes in all. 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 10 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.