Abortion, Second TrimesterNCT06799052
Cervical Preparation for Same-Day Dilation & Evacuation
A study testing Transcervical single-balloon catheter and Synthetic osmotic dilators in people with Abortion, Second Trimester and Procedural Pain, run by Boston Medical Center at 1 site in United States.
Trial summary
This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \& Evacuation (D\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Second Trimester, Procedural Pain, Procedural Complication
- What is being tested?
- Transcervical single-balloon catheter and Synthetic osmotic dilators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2025to Dec 2026
- Phase
- Interventional
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period)
- Able to provide informed consent
- English- or Spanish-speaking
- Singleton intrauterine pregnancy
Who cannot join
- Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators
- Fetal demise or known fetal anomaly
- BMI >45
- Incarceration or other inability to give informed consent
- Decide to undergo cervical preparation overnight prior to next-day D\&E
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
Boston Medical Center
Boston, Massachusetts, 02118
Anjanique M Lu, MD, 617-414-5716, anjaniquemariquit.lu@bmc.org
Pauline Yang, BS, 617 414 5716, yangp@bu.edu
About this study
Official title: Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators
This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \& Evacuation (D\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure.
The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\&E operative time.
Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.
- Being tested
- Transcervical single-balloon catheter, Synthetic osmotic dilators
- Keywords
- Cervical Dilation and Evacuation (D&E), Transcervical single-balloon catheter, Osmotic dilators, Adequate dilation, Patient satisfaction
- Medical subject headings
- Pain, Procedural, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcervical single-balloon catheterDevice
Also called Foley catheter
A single-balloon (Foley) catheter will be placed through the cervix and filled to 30cc of water or saline. The balloon will remain in the participant until their procedure, usually 3-4 hours, or earlier if it falls out on its own.
Synthetic osmotic dilatorsDevice
Also called Dilapan-S, seaweed laminaria
Dilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter.
| Study group | Role | What they receive |
|---|---|---|
| Transcervical single-balloon catheter group | Experimental | Participants randomized to this arm will have cervical dilation done using a transcervical single-balloon catheter. Receives: Device: Transcervical single-balloon catheter |
| Osmotic dilators group | Active comparator | Participants randomized to this arm will have cervical dilation done using osmotic dilators. Receives: Device: Synthetic osmotic dilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dilation & Evacuation (D&E) Operative time
the total duration in D\&E operative time measured in minutes. Operative start time will be marked as the time that the speculum is inserted for the first time. Operative end time will be marked as the time that the speculum is removed at the end of the case.
Measured: at end of procedure about 20 minutes
Secondary outcomes (5)
Participant preoperative pain
Participant pain will be assessed via a 100 point visual analog scale immediately post-cervical preparation and at every hour interval until their D\&E. Higher scores are associated with more pain.
Measured: every hour until procedure, on average 3 hours
Participant satisfaction
Participant satisfaction will be assessed with a 5-point Likert scale from very dissatisfied to very satisfied.
Measured: after dilation, on average 3 hours
Cervical dilation
Cervical dilation will be measured in millimeters at the beginning of the procedure by the surgeon.
Measured: beginning of procedure, on average 3 hours
Number of participants with adequate cervical dilation
Abstracted from the operative record, dilation will be considered adequate if no manual dilation is needed.
Measured: beginning of procedure, on average 3 hours
Number of participants with surgery completed in the same day
Abstracted from the electronic medical record, whether the surgery was completed in the same day as the dilation will be recorded as yes or no.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start12 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, Second TrimesterStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a noninferiority parallel randomized control trial of two cervical preparation methods prior to same-day D\&E.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anjanique Mariquit Lu, MD, Principal investigator, Boston Medical Center, Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799052
- Sponsor's protocol ID
- H-45533
- Status last verified
- Jun 2026
- First submitted
- 23 Jan 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators
- ClinicalTrials.gov ID
- NCT06799052
- Acronym / sponsor ID
- H-45533
- Keywords
- Cervical Dilation and Evacuation (D&E), Transcervical single-balloon catheter, Osmotic dilators, Adequate dilation, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jan 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 is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \& Evacuation (D\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure.
The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\&E operative time.
Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a noninferiority parallel randomized control trial of two cervical preparation methods prior to same-day D\&E.
| Arm | Type | Receives |
|---|---|---|
| Transcervical single-balloon catheter group | Experimental | Device: Transcervical single-balloon catheterParticipants randomized to this arm will have cervical dilation done using a transcervical single-balloon catheter. |
| Osmotic dilators group | Active comparator | Device: Synthetic osmotic dilatorsParticipants randomized to this arm will have cervical dilation done using osmotic dilators. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period)
- Able to provide informed consent
- English- or Spanish-speaking
- Singleton intrauterine pregnancy
Key exclusion criteria (5 listed)
- Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators
- Fetal demise or known fetal anomaly
- BMI >45
- Incarceration or other inability to give informed consent
- Decide to undergo cervical preparation overnight prior to next-day D\&E
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 |
|---|---|---|
| Transcervical single-balloon catheterAlso: Foley catheterA single-balloon (Foley) catheter will be placed through the cervix and filled to 30cc of water or saline. The balloon will remain in the participant until their procedure, usually 3-4 hours, or earlier if it falls out on its own. | Device | Transcervical single-balloon catheter group |
| Synthetic osmotic dilatorsAlso: Dilapan-S, seaweed laminariaDilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter. | Device | Osmotic dilators group |
Primary outcome
Dilation & Evacuation (D&E) Operative time
Time frame: at end of procedure about 20 minutes
the total duration in D\&E operative time measured in minutes. Operative start time will be marked as the time that the speculum is inserted for the first time. Operative end time will be marked as the time that the speculum is removed at the end of the case.
5 secondary outcomes
Participant preoperative pain
Time frame: every hour until procedure, on average 3 hours
Participant satisfaction
Time frame: after dilation, on average 3 hours
Cervical dilation
Time frame: beginning of procedure, on average 3 hours
Number of participants with adequate cervical dilation
Time frame: beginning of procedure, on average 3 hours
Number of participants with surgery completed in the same day
Time frame: 12 months
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 30 Jun 2026.
- 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.
Anjanique Mariquit Lu, MD principal investigator
Boston Medical Center, Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcervical single-balloon catheter and Synthetic osmotic dilators in people with Abortion, Second Trimester and Procedural Pain, run by Boston Medical Center 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 4 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 30 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Anjanique Mariquit Lu, MD (617 414 5716, anjaniquemariquit.lu@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dilation & Evacuation (D&E) Operative time (time frame: at end of procedure about 20 minutes). 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 30 Jun 2026.