Abortion in Second TrimesterOPIOIDNCT03710239
OPIOID Study - Pain With Osmotic Dilators
A study testing Dilapan-S and Laminaria in people with Abortion in Second Trimester, run by Albany Medical College at 1 site in United States.
Trial summary
Comparison of pain levels and pain medications utilized following insertion of two different types of osmotic dilators. 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 in Second Trimester
- What is being tested?
- Dilapan-S and Laminaria
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 11 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- scheduled D\&E for 15+0 to 23+6 wga
- ability to speak and read in English
- ownership of smartphone with internet access and data plan
Who cannot join
- chronic pain, fibromyalgia, active pelvic infection, inability to take NSAIDS, current use of narcotics
Trial locations and contacts
1 site in 1 country.
United States1 site
Albany Medical Center Obstetrics and Gynecology
Albany, New York, 12208
About this study
Official title: OPIOID Study: Opioid Use and Pain After Insertion of Osmotic Dilators
Comparison of pain levels and pain medications utilized following insertion of two different types of osmotic dilators.
Read the detailed description
This is a randomized controlled trial to assess and compare pain levels and pain medication needs following placement of Laminaria versus Dilapan-S for cervical preparation prior to second-trimester dilation and evacuation (D\&E) procedures. Pain levels and medication usage will also be assessed following the D\&E procedure itself, up to 7 days after the procedure.
- Conditions
- Abortion in Second Trimester
- Being tested
- Dilapan-S, Laminaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilapan-SDevice
Synthetic osmotic dilator
LaminariaDevice
Seaweed-based osmotic dilator
| Study group | Role | What they receive |
|---|---|---|
| Dilapan-S | Active comparator | Synthetic osmotic dilator Receives: Device: Dilapan-S |
| Laminaria | Active comparator | Seaweed-based osmotic dilator Receives: Device: Laminaria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain above baseline following Laminaria versus Dilapan-S placement
Timed surveys measuring pain on Numeric Rating Scale (0-10), administered approximately 24 hours after dilator placement
Measured: First 24 hours after dilator placement
Time of maximum pain above baseline following Laminaria versus Dilapan-S placement
Timing of maximum Numeric Rating Scale (0-10) pain difference among measurements approximately 24 hours after dilator placement
Measured: First 24 hours after dilator placement
Secondary outcomes (3)
Pain medication use after Laminaria versus Dilapan-S placement
Timed surveys of pain medication usage at 2 hours, 4 hours, 8 hours, and approximately 24 hours after dilator placement
Measured: First 24 hours after dilator placement
Maximum pain increase over baseline following D&E procedure
Timed surveys measuring pain on Numeric Rating Scale (0-10), administered at 1 hour, 4 hours, 24 hours, 48 hours, and 1 week after D\&E procedure
Measured: First week after D&E
Pain medication use after D&E
Timed surveys of pain medication usage, administered at 4 hours, 24 hours, 48 hours, and 1 week after D\&E procedure
Measured: First week after D&E
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start2 Oct 2018
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion in 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
- Participants will be randomly assigned to receive one of two existing dilator times, with the remainder of care and study procedures being identical.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710239
- Sponsor's protocol ID
- 5209
- Acronym
- OPIOID
- Status last verified
- Mar 2020
- First submitted
- 14 Oct 2018
- Last updated
- 16 Mar 2020
- 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 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPIOID Study: Opioid Use and Pain After Insertion of Osmotic Dilators
- ClinicalTrials.gov ID
- NCT03710239
- Acronym / sponsor ID
- OPIOID / 5209
- Conditions
- Abortion in Second Trimester
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 18 Oct 2018 (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.
Comparison of pain levels and pain medications utilized following insertion of two different types of osmotic dilators.
Detailed description
This is a randomized controlled trial to assess and compare pain levels and pain medication needs following placement of Laminaria versus Dilapan-S for cervical preparation prior to second-trimester dilation and evacuation (D\&E) procedures. Pain levels and medication usage will also be assessed following the D\&E procedure itself, up to 7 days after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive one of two existing dilator times, with the remainder of care and study procedures being identical.
| Arm | Type | Receives |
|---|---|---|
| Dilapan-S | Active comparator | Device: Dilapan-SSynthetic osmotic dilator |
| Laminaria | Active comparator | Device: LaminariaSeaweed-based osmotic dilator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled D\&E for 15+0 to 23+6 wga
- ability to speak and read in English
- ownership of smartphone with internet access and data plan
Key exclusion criteria (1 listed)
- chronic pain, fibromyalgia, active pelvic infection, inability to take NSAIDS, current use of narcotics
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 |
|---|---|---|
| Dilapan-SSynthetic osmotic dilator | Device | Dilapan-S |
| LaminariaSeaweed-based osmotic dilator | Device | Laminaria |
Primary outcome
Maximum pain above baseline following Laminaria versus Dilapan-S placement
Time frame: First 24 hours after dilator placement
Timed surveys measuring pain on Numeric Rating Scale (0-10), administered approximately 24 hours after dilator placement
Time of maximum pain above baseline following Laminaria versus Dilapan-S placement
Time frame: First 24 hours after dilator placement
Timing of maximum Numeric Rating Scale (0-10) pain difference among measurements approximately 24 hours after dilator placement
3 secondary outcomes
Pain medication use after Laminaria versus Dilapan-S placement
Time frame: First 24 hours after dilator placement
Maximum pain increase over baseline following D&E procedure
Time frame: First week after D&E
Pain medication use after D&E
Time frame: First week after D&E
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- 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. 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 Dilapan-S and Laminaria in people with Abortion in Second Trimester, run by Albany Medical College 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 1 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 16 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum pain above baseline following Laminaria versus Dilapan-S placement (time frame: First 24 hours after dilator placement). 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 16 Mar 2020.