Abortion, Second TrimesterNCT05099991
Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion
A study testing Single Foley Balloon and Dilapan-S in people with Abortion, Second Trimester, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a Foley balloon is similar to osmotic dilators for preparing the cervix prior to a second trimester abortion. Procedure time will be used to compare the two different methods of cervical preparation, reflecting the ease at which the surgeon can perform through a… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Second Trimester
- What is being tested?
- Single Foley Balloon and Dilapan-S
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- presenting to clinic for second trimester abortion at 18 to 23 weeks and 6 days gestation confirmed by ultrasound
- able to provide informed consent and comply with study protocol
- English or Spanish-speaking
- candidate for outpatient cervical preparation
Who cannot join
- Anyone with an allergy to misoprostol, mifepristone or any study medication
- premature rupture of membranes
- intrauterine fetal demise
- placenta previa
- suspected abnormal placentation
- evidence of infection at the time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion: a Non-Inferiority Randomized Trial
The purpose of this study is to determine whether a Foley balloon is similar to osmotic dilators for preparing the cervix prior to a second trimester abortion. Procedure time will be used to compare the two different methods of cervical preparation, reflecting the ease at which the surgeon can perform through a prepared cervix. The aim is to expand effective options for cervical preparation that will can accommodate for varying patient characteristics and provider experiences.
- Conditions
- Abortion, Second Trimester
- Being tested
- Single Foley Balloon, Dilapan-S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Foley BalloonDevice
Foley Balloon will be placed through the cervix and inflated with 30mL of saline or water on the day prior to the procedure
Dilapan-SDevice
Dilapan S will be placed through the cervix on the day prior to the procedure
| Study group | Role | What they receive |
|---|---|---|
| Dilapan-S | Placebo comparator | A number of Dilapan-S will be inserted for cervical preparation. The number will be determined by a standard protocol that is based on gestational age. The dilators will stay in until the next day prior to their procedure, or earlier if they fall out on their own. Receives: Device: Dilapan-S |
| Foley balloon | Experimental | A Foley balloon will be inserted for cervical preparation and filled to 30mL of water or saline. The balloon will stay in until the next day prior to their procedure, or earlier if it falls out on its own. Receives: Device: Single Foley Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Time
Time to speculum in to speculum out
Measured: Up to approximately 30 minutes
Secondary outcomes (1)
Cervical Dilation
Measure the cervical dilation after removal of the Foley balloon or Dilapan-S
Measured: Beginning of the procedure (approximately 5 seconds to assess)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start8 Feb 2022
- Primary completion27 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion, Second TrimesterStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099991
- Sponsor's protocol ID
- IRB-63172
- Status last verified
- Mar 2024
- First submitted
- 17 Oct 2021
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Liu SM, Henkel A, Meza P, Shorter JM, Cahill E, Blumenthal PD, Shaw KA. Comparing transcervical balloon with osmotic dilators for cervical preparation prior to procedural abortion: A noninferiority randomized trial. Contraception. 2024 Dec;140:110550. doi: 10.1016/j.contraception.2024.110550. Epub 2024 Jul 25.
PubMed 39067560
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion: a Non-Inferiority Randomized Trial
- ClinicalTrials.gov ID
- NCT05099991
- Acronym / sponsor ID
- IRB-63172
- Conditions
- Abortion, Second Trimester
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Posted 18 Apr 2024
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 determine whether a Foley balloon is similar to osmotic dilators for preparing the cervix prior to a second trimester abortion. Procedure time will be used to compare the two different methods of cervical preparation, reflecting the ease at which the surgeon can perform through a prepared cervix. The aim is to expand effective options for cervical preparation that will can accommodate for varying patient characteristics and provider experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dilapan-S | Placebo comparator | Device: Dilapan-SA number of Dilapan-S will be inserted for cervical preparation. The number will be determined by a standard protocol that is based on gestational age. The dilators will stay in until the next day prior to their procedure, or earlier if they fall out on their own. |
| Foley balloon | Experimental | Device: Single Foley BalloonA Foley balloon will be inserted for cervical preparation and filled to 30mL of water or saline. The balloon will stay in until the next day prior to their procedure, or earlier if it falls out on its own. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- presenting to clinic for second trimester abortion at 18 to 23 weeks and 6 days gestation confirmed by ultrasound
- able to provide informed consent and comply with study protocol
- English or Spanish-speaking
- candidate for outpatient cervical preparation
Key exclusion criteria (6 listed)
- Anyone with an allergy to misoprostol, mifepristone or any study medication
- premature rupture of membranes
- intrauterine fetal demise
- placenta previa
- suspected abnormal placentation
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 |
|---|---|---|
| Single Foley BalloonFoley Balloon will be placed through the cervix and inflated with 30mL of saline or water on the day prior to the procedure | Device | Foley balloon |
| Dilapan-SDilapan S will be placed through the cervix on the day prior to the procedure | Device | Dilapan-S |
Primary outcome
Procedure Time
Time frame: Up to approximately 30 minutes
Time to speculum in to speculum out
1 secondary outcome
Cervical Dilation
Time frame: Beginning of the procedure (approximately 5 seconds to assess)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39067560Liu SM, Henkel A, Meza P, Shorter JM, Cahill E, Blumenthal PD, Shaw KA. Comparing transcervical balloon with osmotic dilators for cervical preparation prior to procedural abortion: A noninferiority randomized trial. Contraception. 2024 Dec;140:110550. doi: 10.1016/j.contraception.2024.110550. Epub 2024 Jul 25.
- Individual participant dataSharing planned: No
Related trials for Abortion, Second Trimester
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Foley Balloon and Dilapan-S in people with Abortion, Second Trimester, run by Stanford University 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 6 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: finished, as of the sponsor's last update on 18 Apr 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Time (time frame: Up to approximately 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05099991, which also lists 1 linked publication.
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 18 Apr 2024.