Add-on Effectiveness of EA or TENS in Early Postpartum Breast Engorgement (NCT04998565) | Clinical Trial Compass
TerminatedNot Applicable
Add-on Effectiveness of EA or TENS in Early Postpartum Breast Engorgement
Stopped: No grants from the Ministry of Science and Technology or school grants, no funds can be executed, so the application is terminated.
Taiwan2 participantsStarted 2017-09-12
Plain-language summary
A total of 36 volunteers of postpartum women within 7 days with significant breast engorgement, will be recruited in China Medical University Hospital, Taichung, Taiwan. The participants will be randomly assigned into 3 groups, each of 12 people, namely, routine care group, routine care plus electrical-acupuncture experiment group, and routine care plus transcutaneous electrical nerve stimulation group.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Gestational age \> 37 wk
* Delivery of singleton, healthy newborn baby
* Within 7 days postpartum
* Within 24 hours from initial painful breast engorgement
* Difficulty on lactation due to plugged ducts, SI index ≧ 5 (0-19)
Exclusion Criteria:
* Fever\>37.5∘C
* Mastitis or breast abscess
* Signs of sepsis or other infection
* Perinatal mother and infant diseases (Gestational hypertension、Gestational Diabetes Mellitus、Pre-eclampsia 、Gestational thyroid diseases or Intrauterine growth retardation)
* Psychological diseases
* Bleeding tendency
* Artificial valves
* Pacemaker
* Epilepsy
* Consciousness disturbance
* Skin infections
* Hepatitis B carrier
* Acquired Immune Deficiency Syndrome
* Breast tumors
* Breast Surgeries
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Severity Index (0-19)
Timeframe: Changes from Baselines of Severity Index, at each treatment and 1 month later