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The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA

RecruitingNAAges 18 Years - anyFemaleChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

Objectives: To prospectively evaluate the potential of acu-TENS to reduce the pain experienced by women undergoing ultrasound-guided manual vacuum aspiration (USG-MVA) and evaluate its safety profile. Hypothesis to be tested: Does the use of acu-TENS reduce pain in women undergoing USG-MVA? Design and subjects: A prospective randomized control trial will be carried out at the Department of Obstetrics and Gynaecology of the Prince of Wales Hospital. Women undergoing USG-MVA for the treatment of early pregnancy loss before 12 weeks of gestation will be randomized to receive acu-TENS (intervention group) or sham acu-TENS (control group) for pain control during USG-MVA. We will recruit 54 participants in each of the two arms, so a total of 108 patients will be recruited. Study instruments: USG-MVA will be performed using a 60ml charged syringe (MedGyn Aspiration Kit) with a flexible curet

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Aged 18 or above; 2. Patient diagnosed with first-trimester miscarriage, who is eligible for USG-MVA; 3. Patient diagnosed with incomplete miscarriage after medical treatment; 4. Willing to be randomized to receive acupuncture. Exclusion criteria a. Patient not eligible for USG-MVA i. Miscarriage \> 12 weeks of gestation; or ii. Pregnancy of unknown origin; or iii. Known narrowing of the cervical canal; or iv. Multiple uterine fibroids; or v. Congenital uterine anomalies; or vi. Active pelvic infection; or vii. Bleeding disorder; or viii. Inability to tolerate pelvic examination; or ix. History of allergy to misoprostol b. Patient not eligible for acu-TENS i. Poor skin integrity at the acupuncture site, such as open wound, infections, unknown mass, bleeding tendency; or ii. Allergic to external alcohol; or iii. Emotionally unstable or tend to restlessness (to avoid tear-off of pads). c. Patient refusal
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What it tests

  • Acu-TENS
  • Sham acu-TENS
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Where

1 site
Prince of Wales Hospital
Hong Kong, Hong Kong
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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