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Reducing pain during second trimester genetic amniocentesis using postprocedural cryotherapy; a randomized controlled trial.

Reducing pain during genetic amniocentesis using postprocedural cryotherapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20191116001
Enrollment
240
Registered
2019-11-16
Start date
2019-11-13
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Expected pain during amniocentesis Actual pain during amniocentesis Pain after amniocenetesis 15 minutes Pain after amniocenetesis 30 minutes

Interventions

Room temperature jelly pack place on the lower abdominal wall of participants after amniocentesis for 30 minutes. The participants will be asked to complete the visual analog scale (VAS) to qualify th
procedure and post&#45
procedure anticipated pain levels.,Cold jelly pack place on the lower abdominal wall of participants after amniocentesis for 30 minutes. The participants will be asked to complete the visual analog sc
procedure anticipated pain levels.
Experimental Device,Experimental Device
Room temperature jelly pack,Cold jelly pack

Sponsors

Faculty of medicine, Thammasart university.
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Pregnant women between 15 and 20 weeks of gestation.

Exclusion criteria

Exclusion criteria: 1. Multifetal gestation 2. Severe congenital anomaly after sonographic detection 3. More than one attempt of needle insertion 4. History of cold urticaria 5. Known or suspected Raynaud phanomenon 6. Known or suspected skin infection at anterior abdominal wall 7. Psychiatric disease 8. Participants who declined to enroll in this study

Design outcomes

Primary

MeasureTime frame
pain 0, 15 and 30 minutes after end of intervention visual analog scale

Secondary

MeasureTime frame
Side effect 0, 15 and 30 minutes after end of intervention Side effect from hypothermia

Countries

Thailand

Contacts

Public ContactOrawee Kuemanee

Thammasart university

kue.orawee@gmail.com0897330795

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026