Abortion LateNCT02354092
Paracervical Block for Pain Control With Osmotic Dilator Placement
A study testing Local anesthetic for tenaculum placement, Paracervical Block and Dilator Placement in people with Abortion Late and Pain, run by University of California, San Diego at 2 sites in United States.
Trial summary
Cervical dilators are frequently used for preparation prior to second trimester surgical abortion. While their use decreases complications associated with surgical abortion, their placement is often uncomfortable for the patient. Currently there are no proven methods for reducing pain during osmotic dilator placement. 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 Late, Pain
- What is being tested?
- Local anesthetic for tenaculum placement, Paracervical Block and Dilator Placement
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Apr 2015to 25 Aug 2015
- 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
- voluntarily seeking surgical pregnancy termination
- gestational age on day of study 14w0d to 23w6d confirmed by pelvic ultrasound with a viable pregnancy (no fetal demise diagnosed)
- eligible for second trimester D\&E
- having osmotic dilators placed for cervical preparation the day prior to D\&E
- able and willing to give informed consent and agree to terms of the study
- able to speak and read English or Spanish
Who cannot join
- took any prescription or illegal drugs 24 hours prior to the appointment
- drank alcohol 12 hours prior to the appointment
- took any over the counter pain medications 12 hours prior to the appointment other than the standard 800mg of Ibuprofen
- contraindications to osmotic dilators
- allergic reaction or hypersensitivity to NSAIDs or lidocaine
- untreated acute cervicitis or pelvic inflammatory disease
- weight <100 pounds
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood of the Pacific Southwest: First Avenue Family Planning Michelle Wagner Center
San Diego, California, 92101
UCSD Medical Offices South: Women's Health Services
San Diego, California, 92103
About this study
Official title: Paracervical Block for Pain Control During Osmotic Dilator Placement: a Randomized Controlled Trial
Cervical dilators are frequently used for preparation prior to second trimester surgical abortion. While their use decreases complications associated with surgical abortion, their placement is often uncomfortable for the patient. Currently there are no proven methods for reducing pain during osmotic dilator placement. The use of numbing medication around the cervix (paracervical block) may decrease this placement pain.
Read the detailed description
It is estimated that 1.21 million abortions were performed in 2008. Of these, approximately 11% occurred in the second trimester and 1.4% occurred after 21 weeks gestation. In the United States, dilation and evacuation (D\&E) is the most common method of terminating a second trimester pregnancy with greater than 98% of second trimester abortions occurring by D\&E.
Pre-procedure cervical preparation decreases the incidence of complications associated with D\&E. Cervical dilators are often used prior to second trimester D\&Es to aid in softening and dilating the cervix. Typically, dilator placement occurs the day of the D\&E or 1-2 days prior and oftentimes occurs in an outpatient clinic setting without anesthesia readily available. Many women experience moderate to severe discomfort with osmotic dilator insertion. Providers use various methods to minimize this discomfort including paracervical block (PCB), non-steroidal anti-inflammatory medications (NSAIDs), anxiolytics and narcotics. In particular, PCB and NSAIDs are readily available in the clinic setting and can be used for this purpose. There is, however, no data to support their efficacy in ameliorating the pain of dilator insertion.
Paracervical blocks are used commonly to decrease pain in abortion procedures and other gynecological procedures. The PCB is thought to work primarily by blocking pain conduction via Frankenhauser's plexus. As such, their effect may be most important in relieving the pain associated with cervical dilation. In a recent randomized control trial, PCB prior to first trimester surgical abortion was found to significantly reduce pain with cervical dilation and uterine aspiration. Since osmotic dilator placement primarily involves cervical manipulation and dilation, PCB may provide some pain relief over placebo. The research team proposes a randomized controlled trial to evaluate the efficacy of a PCB in decreasing pain associated with osmotic dilator placement. This trial will also provide information about the degree of pain that women experience during osmotic dilator placement; information not previously known.
- Conditions
- Abortion Late, Pain
- Being tested
- Local anesthetic for tenaculum placement, Sham, Paracervical Block, Dilator Placement, Post-procedural assessment
- Keywords
- cervical dilation, pain, paracervical block, osmotic dilators
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthetic for tenaculum placementProcedure or surgery
2 mL of buffered Lidocaine injected superficially at anterior lip of cervix in 12 o'clock position Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate
ShamProcedure or surgery
Over 60 seconds, without moving the tenaculum, a capped needle gently touches the vaginal sidewall at the level of the external os at 4 and 8 o'clock positions
Paracervical BlockProcedure or surgery
18 mL of buffered Lidocaine is slowly injected into the vaginal fornices and equally distributed at 4 and 8 o'clock. The injection is continuous from superficial to deep (3cm) to superficial (injecting with insertion and withdrawal) Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate
Dilator PlacementProcedure or surgery
Osmotic dilators will be placed in the usual fashion with a combination of Dilapan-S and laminaria per clinician preference
Drugs:
Dilapan-S is a hygroscopic cervical dilator made of a patented hydrogel called AQUACRYL. It is a rigid hydrophilic stick that increases in volume by absorbing fluids and comfortably dilating the cervix.
Laminaria is an herbal medicine used to induce labor and abortion. The dried stem of Laminaria mechanically dilates the cervical opening by absorbing water and swelling to several times its original diameter.
Post-procedural assessmentBehavioural
15 minutes after procedure, subjects will complete a questionnaire that collects information about pain, negative symptoms, and assessment of how effective their pain management was.
Preprocedural pain controlDrug
800 mg Ibuprofen taken before dilator placement
| Study group | Role | What they receive |
|---|---|---|
| Sham Group | Sham comparator | This non-intervention group will receive the sham paracervical block. This intervention will include
* Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement
* Local anesthetic for tenaculum placement
* Sham Paracervical Block done with capped spinal needle
* osmotic dilators placed in the usual fashion
* postprocedural assessment Receives: Procedure: Local anesthetic for tenaculum placement; Procedure: Sham; Procedure: Dilator Placement; Behavioral: Post-procedural assessment; Drug: Preprocedural pain control |
| Paracervical Block Group | Experimental | This intervention group will receive the paracervical block. This intervention will include
* Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement
* Local anesthetic for tenaculum placement
* 18 ml 1% buffered lidocaine Paracervical Block
* osmotic dilators placed in the usual fashion
* postprocedural assessment Receives: Procedure: Local anesthetic for tenaculum placement; Procedure: Paracervical Block; Procedure: Dilator Placement; Behavioral: Post-procedural assessment; Drug: Preprocedural pain control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at Time of Osmotic Dilator Placement
Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after osmotic dilator placement. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain.
Measured: Within 5 minutes of PCB or sham procedure
Secondary outcomes (3)
Pain With Paracervical Block or Sham
Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after last injection for paracervical block OR script for sham injection. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain.
Measured: Within 5 minutes after baseline
Reported Pain at Baseline
Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) of pain recorded at baseline prior to the paracervical block or sham block procedure. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain.
Measured: Baseline, just prior to PCB or sham procedure
Pain With Overall Dilator Placement
Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded 15 minutes after osmotic dilator placement. mm=No Pain and 100 mm= worst possible pain. A higher mean score indicates a higher level of pain experienced at this time point.
Measured: 15 minutes after dilator placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study start2 Apr 2015
- Primary completion25 Aug 2015
- Study completion25 Aug 2015
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 (9)Papers the sponsor has linked to this study.
- Other trials for Abortion LateStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood Federation of America
- Responsible party
- Principal investigator, Lisa Bayer, University of California, San Diego
- Investigators
- Lisa Bayer, MD MPH, Principal investigator, UCSD Department of Reproductive MedicineSheila Mody, MD MPH, Principal investigator, UCSD Department of Reproductive MedicineKelly Culwell, MD MPH, Principal investigator, Planned Parenthood of the Pacific Southwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354092
- Sponsor's protocol ID
- 141593
- Status last verified
- May 2019
- First submitted
- 29 Jan 2015
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Glantz JC, Shomento S. Comparison of paracervical block techniques during first trimester pregnancy termination. Int J Gynaecol Obstet. 2001 Feb;72(2):171-8. doi: 10.1016/s0020-7292(00)00292-7.
PubMed 11166751Jensen 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 14622683Jones RK, Zolna MR, Henshaw SK, Finer LB. Abortion in the United States: incidence and access to services, 2005. Perspect Sex Reprod Health. 2008 Mar;40(1):6-16. doi: 10.1363/4000608.
PubMed 18318867Peterson WF, Berry FN, Grace MR, Gulbranson CL. Second-trimester abortion by dilatation and evacuation: an analysis of 11,747 cases. Obstet Gynecol. 1983 Aug;62(2):185-90.
PubMed 6866362Cansino C, Edelman A, Burke A, Jamshidi R. Paracervical block with combined ketorolac and lidocaine in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1220-1226. doi: 10.1097/AOG.0b013e3181c1a55b.
PubMed 19935022Rowbotham 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 11690725Schulz KF, Grimes DA, Cates W Jr. Measures to prevent cervical injury during suction curettage abortion. Lancet. 1983 May 28;1(8335):1182-5. doi: 10.1016/s0140-6736(83)92464-9.
PubMed 6133988Strauss LT, Gamble SB, Parker WY, Cook DA, Zane SB, Hamdan S; Centers for Disease Control and Prevention. Abortion surveillance--United States, 2003. MMWR Surveill Summ. 2006 Nov 24;55(11):1-32.
PubMed 17119534Todd 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 8604867
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracervical Block for Pain Control During Osmotic Dilator Placement: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02354092
- Acronym / sponsor ID
- 141593
- Conditions
- Abortion Late, Pain
- Keywords
- cervical dilation, pain, paracervical block, osmotic dilators
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Planned Parenthood Federation of America
- Study start
- 2 Apr 2015 (actual)
- Primary completion
- 25 Aug 2015 (actual)
- Study completion
- 25 Aug 2015 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Posted 11 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cervical dilators are frequently used for preparation prior to second trimester surgical abortion. While their use decreases complications associated with surgical abortion, their placement is often uncomfortable for the patient. Currently there are no proven methods for reducing pain during osmotic dilator placement. The use of numbing medication around the cervix (paracervical block) may decrease this placement pain.
Detailed description
It is estimated that 1.21 million abortions were performed in 2008. Of these, approximately 11% occurred in the second trimester and 1.4% occurred after 21 weeks gestation. In the United States, dilation and evacuation (D\&E) is the most common method of terminating a second trimester pregnancy with greater than 98% of second trimester abortions occurring by D\&E.
Pre-procedure cervical preparation decreases the incidence of complications associated with D\&E. Cervical dilators are often used prior to second trimester D\&Es to aid in softening and dilating the cervix. Typically, dilator placement occurs the day of the D\&E or 1-2 days prior and oftentimes occurs in an outpatient clinic setting without anesthesia readily available. Many women experience moderate to severe discomfort with osmotic dilator insertion. Providers use various methods to minimize this discomfort including paracervical block (PCB), non-steroidal anti-inflammatory medications (NSAIDs), anxiolytics and narcotics. In particular, PCB and NSAIDs are readily available in the clinic setting and can be used for this purpose. There is, however, no data to support their efficacy in ameliorating the pain of dilator insertion.
Paracervical blocks are used commonly to decrease pain in abortion procedures and other gynecological procedures. The PCB is thought to work primarily by blocking pain conduction via Frankenhauser's plexus. As such, their effect may be most important in relieving the pain associated with cervical dilation. In a recent randomized control trial, PCB prior to first trimester surgical abortion was found to significantly reduce pain with cervical dilation and uterine aspiration. Since osmotic dilator placement primarily involves cervical manipulation and dilation, PCB may provide some pain relief over placebo. The research team proposes a randomized controlled trial to evaluate the efficacy of a PCB in decreasing pain associated with osmotic dilator placement. This trial will also provide information about the degree of pain that women experience during osmotic dilator placement; information not previously known.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Group | Sham comparator | Procedure: Local anesthetic for tenaculum placement, Procedure: Sham, Procedure: Dilator Placement, Behavioral: Post-procedural assessment, Drug: Preprocedural pain controlThis non-intervention group will receive the sham paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * Sham Paracervical Block done with capped spinal needle * osmotic dilators placed in the usual fashion * postprocedural assessment |
| Paracervical Block Group | Experimental | Procedure: Local anesthetic for tenaculum placement, Procedure: Paracervical Block, Procedure: Dilator Placement, Behavioral: Post-procedural assessment, Drug: Preprocedural pain controlThis intervention group will receive the paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * 18 ml 1% buffered lidocaine Paracervical Block * osmotic dilators placed in the usual fashion * postprocedural assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- voluntarily seeking surgical pregnancy termination
- gestational age on day of study 14w0d to 23w6d confirmed by pelvic ultrasound with a viable pregnancy (no fetal demise diagnosed)
- eligible for second trimester D\&E
- having osmotic dilators placed for cervical preparation the day prior to D\&E
- able and willing to give informed consent and agree to terms of the study
Key exclusion criteria (7 listed)
- took any prescription or illegal drugs 24 hours prior to the appointment
- drank alcohol 12 hours prior to the appointment
- took any over the counter pain medications 12 hours prior to the appointment other than the standard 800mg of Ibuprofen
- contraindications to osmotic dilators
- allergic reaction or hypersensitivity to NSAIDs or lidocaine
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 |
|---|---|---|
| Local anesthetic for tenaculum placement2 mL of buffered Lidocaine injected superficially at anterior lip of cervix in 12 o'clock position Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate | Procedure or surgery | Paracervical Block Group, Sham Group |
| ShamOver 60 seconds, without moving the tenaculum, a capped needle gently touches the vaginal sidewall at the level of the external os at 4 and 8 o'clock positions | Procedure or surgery | Sham Group |
| Paracervical Block18 mL of buffered Lidocaine is slowly injected into the vaginal fornices and equally distributed at 4 and 8 o'clock. The injection is continuous from superficial to deep (3cm) to superficial (injecting with insertion and withdrawal) Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate | Procedure or surgery | Paracervical Block Group |
| Dilator PlacementOsmotic dilators will be placed in the usual fashion with a combination of Dilapan-S and laminaria per clinician preference Drugs: Dilapan-S is a hygroscopic cervical dilator made of a patented hydrogel called AQUACRYL. It is a rigid hydrophilic stick that increases in volume by absorbing fluids and comfortably dilating the cervix. Laminaria is an herbal medicine used to induce labor and abortion. The dried stem of Laminaria mechanically dilates the cervical opening by absorbing water and swelling to several times its original diameter. | Procedure or surgery | Paracervical Block Group, Sham Group |
| Post-procedural assessment15 minutes after procedure, subjects will complete a questionnaire that collects information about pain, negative symptoms, and assessment of how effective their pain management was. | Behavioural | Paracervical Block Group, Sham Group |
| Preprocedural pain control800 mg Ibuprofen taken before dilator placement | Drug | Paracervical Block Group, Sham Group |
Primary outcome
Pain at Time of Osmotic Dilator Placement
Time frame: Within 5 minutes of PCB or sham procedure
Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after osmotic dilator placement. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain.
3 secondary outcomes
Pain With Paracervical Block or Sham
Time frame: Within 5 minutes after baseline
Reported Pain at Baseline
Time frame: Baseline, just prior to PCB or sham procedure
Pain With Overall Dilator Placement
Time frame: 15 minutes after dilator placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11166751Glantz JC, Shomento S. Comparison of paracervical block techniques during first trimester pregnancy termination. Int J Gynaecol Obstet. 2001 Feb;72(2):171-8. doi: 10.1016/s0020-7292(00)00292-7.
- 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.
- Background: PubMed 18318867Jones RK, Zolna MR, Henshaw SK, Finer LB. Abortion in the United States: incidence and access to services, 2005. Perspect Sex Reprod Health. 2008 Mar;40(1):6-16. doi: 10.1363/4000608.
- Background: PubMed 6866362Peterson WF, Berry FN, Grace MR, Gulbranson CL. Second-trimester abortion by dilatation and evacuation: an analysis of 11,747 cases. Obstet Gynecol. 1983 Aug;62(2):185-90.
- Background: PubMed 19935022Cansino C, Edelman A, Burke A, Jamshidi R. Paracervical block with combined ketorolac and lidocaine in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1220-1226. doi: 10.1097/AOG.0b013e3181c1a55b.
- Background: PubMed 11690725Rowbotham 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.
- Background: PubMed 6133988Schulz KF, Grimes DA, Cates W Jr. Measures to prevent cervical injury during suction curettage abortion. Lancet. 1983 May 28;1(8335):1182-5. doi: 10.1016/s0140-6736(83)92464-9.
- Background: PubMed 17119534Strauss LT, Gamble SB, Parker WY, Cook DA, Zane SB, Hamdan S; Centers for Disease Control and Prevention. Abortion surveillance--United States, 2003. MMWR Surveill Summ. 2006 Nov 24;55(11):1-32.
- Background: PubMed 8604867Todd 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.
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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.
Lisa Bayer, MD MPH principal investigator
UCSD Department of Reproductive Medicine
Sheila Mody, MD MPH principal investigator
UCSD Department of Reproductive Medicine
Kelly Culwell, MD MPH principal investigator
Planned Parenthood of the Pacific Southwest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthetic for tenaculum placement, Paracervical Block and Dilator Placement in people with Abortion Late and Pain, 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 6 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: stopped early, as of the sponsor's last update on 11 Jun 2019. 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. 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 11 Jun 2019). 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 at Time of Osmotic Dilator Placement (time frame: Within 5 minutes of PCB or sham procedure). 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 NCT02354092, which also lists 9 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 11 Jun 2019.