Abortion, SpontaneousPhase 3NCT03636451
Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o
A Phase 3 study testing 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block and 20cc 1% lidocaine with 2 units of vasopressin paracervical block in people with Abortion, Spontaneous and Abortion in First Trimester, run by University of California, San Diego at 2 sites in United States.
Trial summary
The investigators are conducting a study on pain control for dilation and curettage (D\&C). Participants are eligible to enroll if they are a planning to have a D\&C in a participating clinic. The investigators are studying how different ratios of medication to liquid affect pain when injected around the cervix. 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, Spontaneous, Abortion in First Trimester, Pain Uterus
- What is being tested?
- 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block and 20cc 1% lidocaine with 2 units of vasopressin paracervical block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Oct 2018to 27 Sep 2022
- Phase
- Phase 3
- 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
- Women over the age of 18 presenting to UC San Diego and UC Los Angeles
- Undesired pregnancy or missed abortion < 11 weeks 6 days gestation
- Must speak English or Spanish
- Desire surgical termination of pregnancy or management of miscarriage in clinic
Who cannot join
- Women with a diagnosis of inevitable or incomplete abortion
- Desire for general anesthesia or IV sedation
- Chronic pain conditions
- Any medical comorbidities that are a contraindication to performing the procedure in the clinic setting
- Allergy to or refusal of ketorolac, oral Versed, or a paracervical block
- If they have taken any pain medications the day of presentation to clinic
- If they have taken Misoprostol the day of presentation to clinic
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Villa La Jolla Clinic
La Jolla, California, 92037
UCSD Medical Offices South
San Diego, California, 92103
About this study
Official title: Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial
The investigators are conducting a study on pain control for dilation and curettage (D\&C). Participants are eligible to enroll if they are a planning to have a D\&C in a participating clinic. The investigators are studying how different ratios of medication to liquid affect pain when injected around the cervix. Both potential methods use the same dose of medication, though researchers would like to know which one works better. To be in this study, participants must be over the age of 18 with an early pregnancy loss or undesired pregnancy measuring less than 12 weeks gestation undergoing D\&C while awake in clinic.
Read the detailed description
Dilation and Curettage (D\&C) is often performed in the first trimester for surgical abortion and management of miscarriage and can be painful for patients before and after the procedure. Most procedures are performed while the patient is awake or with minimal sedation in the clinic setting, and a key component of pain control is the paracervical block, or injecting lidocaine into the tissue around the cervix. A paracervical block with 20cc of 1% buffered lidocaine has been proven to provide superior pain control than a sham paracervical block. However, many providers often use similar doses of lidocaine in a higher volume to improve pain control. At University of California, San Diego (UCSD) and University of California, Los Angeles (UCLA), some providers routinely use a 20cc of 1% buffered lidocaine block and some routinely use a 40cc of 0.5% buffered lidocaine block. This practice has not been studied in a randomized controlled trial. The purpose of this study is to compare pain control during D\&C with a 20cc 1% buffered lidocaine with vasopressin paracervical block compared to a 40cc 0.5% buffered lidocaine with vasopressin paracervical block.
An inclusion criterion for this study is that patients must specifically be referred to family planning clinics at UCSD and UCLA for an in-clinic D\&C. Therefore, the D\&C is a required procedure for both study groups. The only difference in care between the study groups will be which paracervical block they receive.
- Conditions
- Abortion, Spontaneous, Abortion in First Trimester, Pain Uterus, Abortion Early, Abortion, Missed
- Being tested
- 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block, 20cc 1% lidocaine with 2 units of vasopressin paracervical block
- Keywords
- Dilation & curettage, Paracervical block
- Medical subject headings
- Abortion, Spontaneous, Abortion, Missed, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical blockDrug
Also called 40cc
Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
20cc 1% lidocaine with 2 units of vasopressin paracervical blockDrug
Also called 20cc
Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
| Study group | Role | What they receive |
|---|---|---|
| 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block | Experimental | 40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation Receives: Drug: 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block |
| 20cc 1% lidocaine with 2 units of vasopressin paracervical block | Active comparator | 20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation Receives: Drug: 20cc 1% lidocaine with 2 units of vasopressin paracervical block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain With Cervical Dilation
Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded at time of cervical dilation. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
Measured: Once during the procedure on the day of recruitment, approximately one minute. During procedure at time of cervical dilation.
Secondary outcomes (3)
Pain With Uterine Aspiration
Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded immediately after uterine aspiration. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
Measured: Once during the procedure on the day of recruitment, approximately 1 minute. During procedure immediately after uterine aspiration.
Pain 10 Minutes Post Procedure
Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded 10 minutes after the completion of the procedure. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
Measured: Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
Overall Pain
Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded after the procedure reflecting the overall pain felt during the procedure. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
Measured: Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start29 Oct 2018
- Primary completion14 Dec 2020
- Study completion27 Sep 2022
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 (17)Papers the sponsor has linked to this study.
- Other trials for Abortion, SpontaneousStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double center, randomized, 2 arm (1:1), single blinded clinical trial comparing pain control at the time of cervical dilation with two different paracervical blocks in women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning, University of California, Los Angeles
- Responsible party
- Principal investigator, Sheila Mody, University of California, San Diego
- Investigators
- Sheila K Mody, MD MPH, Principal investigator, UCSD Department of Ob/Gyn and Reproductive Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636451
- Sponsor's protocol ID
- 180999.o
- Status last verified
- Mar 2023
- First submitted
- 13 Aug 2018
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Renner RM, Jensen JT, Nichols MD, Edelman A. Pain control in first trimester surgical abortion. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD006712. doi: 10.1002/14651858.CD006712.pub2.
PubMed 19370649Renner RM, Jensen JT, Nichols MD, Edelman AB. Pain control in first-trimester surgical abortion: a systematic review of randomized controlled trials. Contraception. 2010 May;81(5):372-88. doi: 10.1016/j.contraception.2009.12.008. Epub 2010 Jan 27.
PubMed 20399943Meckstroth KR, Mishra K. Analgesia/pain management in first trimester surgical abortion. Clin Obstet Gynecol. 2009 Jun;52(2):160-70. doi: 10.1097/GRF.0b013e3181a2b0e8.
PubMed 19407522Belanger E, Melzack R, Lauzon P. Pain of first-trimester abortion: a study of psychosocial and medical predictors. Pain. 1989 Mar;36(3):339-350. doi: 10.1016/0304-3959(89)90094-8.
PubMed 2710563Rawling MJ, Wiebe ER. Pain control in abortion clinics. Int J Gynaecol Obstet. 1998 Mar;60(3):293-5. doi: 10.1016/s0020-7292(97)00254-3. No abstract available.
PubMed 9544719Stubblefield PG. Control of pain for women undergoing abortion. Suppl Int J Gynecol Obstet. 1989;3:131-40. doi: 10.1016/0020-7292(89)90113-6.
PubMed 2686702Pud D, Amit A. Anxiety as a predictor of pain magnitude following termination of first-trimester pregnancy. Pain Med. 2005 Mar-Apr;6(2):143-8. doi: 10.1111/j.1526-4637.2005.05030.x.
PubMed 15773879O'Connell K, Jones HE, Simon M, Saporta V, Paul M, Lichtenberg ES; National Abortion Federation Members. First-trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception. 2009 May;79(5):385-92. doi: 10.1016/j.contraception.2008.11.005. Epub 2008 Dec 11.
PubMed 19341852Grimes DA, Cates W Jr. Deaths from paracervical anesthesia used for first-trimester abortion, 1972-1975. N Engl J Med. 1976 Dec 16;295(25):1397-9. doi: 10.1056/NEJM197612162952503.
PubMed 980095Renner RM, Nichols MD, Jensen JT, Li H, Edelman AB. Paracervical block for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):1030-7. doi: 10.1097/AOG.0b013e318250b13e.
PubMed 22525915Renner RM, Edelman AB, Nichols MD, Jensen JT, Lim JY, Bednarek PH. Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial. Contraception. 2016 Nov;94(5):461-466. doi: 10.1016/j.contraception.2016.05.005. Epub 2016 May 25.
PubMed 27235677Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.
PubMed 14622683Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-132. doi: 10.1016/S0304-3959(01)00371-2. No abstract available.
PubMed 11690725Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.
PubMed 8604867Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
PubMed 17339617
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03636451
- Acronym / sponsor ID
- 180999.o
- Conditions
- Abortion, Spontaneous, Abortion in First Trimester, Pain Uterus, Abortion Early, Abortion, Missed
- Keywords
- Dilation & curettage, Paracervical block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Society of Family Planning, University of California, Los Angeles
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Posted 20 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are conducting a study on pain control for dilation and curettage (D\&C). Participants are eligible to enroll if they are a planning to have a D\&C in a participating clinic. The investigators are studying how different ratios of medication to liquid affect pain when injected around the cervix. Both potential methods use the same dose of medication, though researchers would like to know which one works better. To be in this study, participants must be over the age of 18 with an early pregnancy loss or undesired pregnancy measuring less than 12 weeks gestation undergoing D\&C while awake in clinic.
Detailed description
Dilation and Curettage (D\&C) is often performed in the first trimester for surgical abortion and management of miscarriage and can be painful for patients before and after the procedure. Most procedures are performed while the patient is awake or with minimal sedation in the clinic setting, and a key component of pain control is the paracervical block, or injecting lidocaine into the tissue around the cervix. A paracervical block with 20cc of 1% buffered lidocaine has been proven to provide superior pain control than a sham paracervical block. However, many providers often use similar doses of lidocaine in a higher volume to improve pain control. At University of California, San Diego (UCSD) and University of California, Los Angeles (UCLA), some providers routinely use a 20cc of 1% buffered lidocaine block and some routinely use a 40cc of 0.5% buffered lidocaine block. This practice has not been studied in a randomized controlled trial. The purpose of this study is to compare pain control during D\&C with a 20cc 1% buffered lidocaine with vasopressin paracervical block compared to a 40cc 0.5% buffered lidocaine with vasopressin paracervical block.
An inclusion criterion for this study is that patients must specifically be referred to family planning clinics at UCSD and UCLA for an in-clinic D\&C. Therefore, the D\&C is a required procedure for both study groups. The only difference in care between the study groups will be which paracervical block they receive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double center, randomized, 2 arm (1:1), single blinded clinical trial comparing pain control at the time of cervical dilation with two different paracervical blocks in women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management.
| Arm | Type | Receives |
|---|---|---|
| 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block | Experimental | Drug: 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation |
| 20cc 1% lidocaine with 2 units of vasopressin paracervical block | Active comparator | Drug: 20cc 1% lidocaine with 2 units of vasopressin paracervical block20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women over the age of 18 presenting to UC San Diego and UC Los Angeles
- Undesired pregnancy or missed abortion < 11 weeks 6 days gestation
- Must speak English or Spanish
- Desire surgical termination of pregnancy or management of miscarriage in clinic
Key exclusion criteria (7 listed)
- Women with a diagnosis of inevitable or incomplete abortion
- Desire for general anesthesia or IV sedation
- Chronic pain conditions
- Any medical comorbidities that are a contraindication to performing the procedure in the clinic setting
- Allergy to or refusal of ketorolac, oral Versed, or a paracervical block
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 |
|---|---|---|
| 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical blockAlso: 40ccWomen undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation. | Drug | 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block |
| 20cc 1% lidocaine with 2 units of vasopressin paracervical blockAlso: 20ccWomen undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation. | Drug | 20cc 1% lidocaine with 2 units of vasopressin paracervical block |
Primary outcome
Pain With Cervical Dilation
Time frame: Once during the procedure on the day of recruitment, approximately one minute. During procedure at time of cervical dilation.
Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded at time of cervical dilation. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
3 secondary outcomes
Pain With Uterine Aspiration
Time frame: Once during the procedure on the day of recruitment, approximately 1 minute. During procedure immediately after uterine aspiration.
Pain 10 Minutes Post Procedure
Time frame: Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
Overall Pain
Time frame: Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19370649Renner RM, Jensen JT, Nichols MD, Edelman A. Pain control in first trimester surgical abortion. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD006712. doi: 10.1002/14651858.CD006712.pub2.
- Background: PubMed 20399943Renner RM, Jensen JT, Nichols MD, Edelman AB. Pain control in first-trimester surgical abortion: a systematic review of randomized controlled trials. Contraception. 2010 May;81(5):372-88. doi: 10.1016/j.contraception.2009.12.008. Epub 2010 Jan 27.
- Background: PubMed 19407522Meckstroth KR, Mishra K. Analgesia/pain management in first trimester surgical abortion. Clin Obstet Gynecol. 2009 Jun;52(2):160-70. doi: 10.1097/GRF.0b013e3181a2b0e8.
- Background: PubMed 2710563Belanger E, Melzack R, Lauzon P. Pain of first-trimester abortion: a study of psychosocial and medical predictors. Pain. 1989 Mar;36(3):339-350. doi: 10.1016/0304-3959(89)90094-8.
- Background: PubMed 9544719Rawling MJ, Wiebe ER. Pain control in abortion clinics. Int J Gynaecol Obstet. 1998 Mar;60(3):293-5. doi: 10.1016/s0020-7292(97)00254-3. No abstract available.
- Background: PubMed 2686702Stubblefield PG. Control of pain for women undergoing abortion. Suppl Int J Gynecol Obstet. 1989;3:131-40. doi: 10.1016/0020-7292(89)90113-6.
- Background: PubMed 15773879Pud D, Amit A. Anxiety as a predictor of pain magnitude following termination of first-trimester pregnancy. Pain Med. 2005 Mar-Apr;6(2):143-8. doi: 10.1111/j.1526-4637.2005.05030.x.
- Background: PubMed 19341852O'Connell K, Jones HE, Simon M, Saporta V, Paul M, Lichtenberg ES; National Abortion Federation Members. First-trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception. 2009 May;79(5):385-92. doi: 10.1016/j.contraception.2008.11.005. Epub 2008 Dec 11.
- Background: PubMed 980095Grimes DA, Cates W Jr. Deaths from paracervical anesthesia used for first-trimester abortion, 1972-1975. N Engl J Med. 1976 Dec 16;295(25):1397-9. doi: 10.1056/NEJM197612162952503.
- Background: PubMed 22525915Renner RM, Nichols MD, Jensen JT, Li H, Edelman AB. Paracervical block for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):1030-7. doi: 10.1097/AOG.0b013e318250b13e.
- Background: PubMed 27235677Renner RM, Edelman AB, Nichols MD, Jensen JT, Lim JY, Bednarek PH. Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial. Contraception. 2016 Nov;94(5):461-466. doi: 10.1016/j.contraception.2016.05.005. Epub 2016 May 25.
- Background: PubMed 14622683Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.
- Guttmacher Institute: Facts on Induced Abortion WorldwideLink provided by the sponsor.
- 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.
Sheila K Mody, MD MPH principal investigator
UCSD Department of Ob/Gyn and Reproductive Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block and 20cc 1% lidocaine with 2 units of vasopressin paracervical block in people with Abortion, Spontaneous and Abortion in First Trimester, run by University of California, San Diego at 2 sites 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 7 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 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2023). 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?
Pain With Cervical Dilation (time frame: Once during the procedure on the day of recruitment, approximately one minute. During procedure at time of cervical dilation.). 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 NCT03636451, which also lists 17 linked publications.
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 20 Apr 2023.