Abortion in First Trimester Clinical Trial
Official title:
Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial
Verified date | March 2023 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 114 |
Est. completion date | September 27, 2022 |
Est. primary completion date | December 14, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Women over the age of 18 presenting to UC San Diego and UC Los Angeles 2. Undesired pregnancy or missed abortion < 11 weeks 6 days gestation 3. Must speak English or Spanish 4. Desire surgical termination of pregnancy or management of miscarriage in clinic Exclusion Criteria: 1. Women with a diagnosis of inevitable or incomplete abortion 2. Desire for general anesthesia or IV sedation 3. Chronic pain conditions 4. Any medical comorbidities that are a contraindication to performing the procedure in the clinic setting 5. Allergy to or refusal of ketorolac, oral Versed, or a paracervical block 6. If they have taken any pain medications the day of presentation to clinic 7. If they have taken Misoprostol the day of presentation to clinic |
Country | Name | City | State |
---|---|---|---|
United States | Villa La Jolla Clinic | La Jolla | California |
United States | UCSD Medical Offices South | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Society of Family Planning, University of California, Los Angeles |
United States,
Belanger 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. — View Citation
Grimes 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. — View Citation
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. — View Citation
Jensen 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. — View Citation
Kroenke 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. — View Citation
Meckstroth 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. — View Citation
O'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. — View Citation
Pud 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. — View Citation
Rawling 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. — View Citation
Renner 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. — View Citation
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. — View Citation
Renner 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. — View Citation
Renner 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. — View Citation
Rowbotham 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. — View Citation
Stubblefield 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. — View Citation
Todd 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. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Once during the procedure on the day of recruitment, approximately one minute. During procedure at time of cervical dilation. | |
Secondary | 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. | Once during the procedure on the day of recruitment, approximately 1 minute. During procedure immediately after uterine aspiration. | |
Secondary | 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. | Once 10 minutes after the procedure on the day of recruitment, approximately one minute. | |
Secondary | 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. | Once 10 minutes after the procedure on the day of recruitment, approximately one minute. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04056637 -
Choice of Modality of Follow up for Medication Abortion
|
N/A | |
Active, not recruiting |
NCT05896657 -
Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713
|
N/A | |
Active, not recruiting |
NCT03736681 -
Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage
|
Phase 1 | |
Completed |
NCT04446572 -
Application of Lactobacillus Salivarius CECT5713 in Infertility of Unknown Origin
|
Phase 2 | |
Not yet recruiting |
NCT03267771 -
Progesterone and Doppler in Recurrent Abortion
|
Phase 4 | |
Recruiting |
NCT05341817 -
The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy
|
Phase 4 | |
Completed |
NCT03079622 -
Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 Weeks
|
N/A | |
Recruiting |
NCT05182008 -
A Patient Decision Aid for Method of Early Abortion: A Randomized Control Trial
|
N/A | |
Completed |
NCT03417362 -
Delivery of Audiovisual Information on Early Medical Abortion
|
N/A | |
Completed |
NCT03896022 -
Auriculotherapy - Pain Management of Aspiration Abortion
|
N/A | |
Completed |
NCT03925129 -
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation
|
N/A | |
Suspended |
NCT03751423 -
Intravenous Ketamine for Pain Control During First Trimester Surgical Abortion
|
Phase 3 | |
Completed |
NCT03480009 -
Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion
|
Phase 3 | |
Completed |
NCT05469594 -
Second-trimester TOP : a Retrospective Study Comparing Complications at 12-14 vs 14-16 Weeks of Gestation
|
||
Completed |
NCT05320432 -
Transcutaneous Electrical Nerve Stimulation for Pain Control During First-trimester Abortion
|
N/A | |
Completed |
NCT03187002 -
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion
|
N/A | |
Terminated |
NCT04139382 -
Using Telemedicine to Improve Early Medical Abortion at Home
|
N/A | |
Recruiting |
NCT04956731 -
Pharmacist Provision of Medication Abortion
|
N/A | |
Recruiting |
NCT04336358 -
Telemedicine for First Trimester Abortion in South Africa
|
N/A | |
Completed |
NCT02096575 -
Nitrous Oxide for Pain Management of First Trimester Surgical Abortion
|
N/A |