Aim of this randomized controlled trial is to comparison between 20G and 22G for second trimester amniocentesis in terms of technical aspects and short-term complications. In this study target population are pregnant women 15 to 21 weeks that refer to Fetal Medicine Unit (FMU) of Alzahra teaching hospital to detect chromosomal abnormalities or genetic disease with amniocentesis.Inclusion criteria: single pregnancy;no history of cervical classic failure,hereditary or non-hereditary coagulation disorders,myoma, major fetal anomalies. By considering α =0.05 and power=80% and 50% difference in pain intensity difference between two group 200 sample was determined for each group. Amniocentesis will be made with 20 gauge needle in one group and will be made with 22G in the other group. The primary outcome of this study is pain intensity during amniocentesis , which will be measured by VAS (Visual Analog Scale) system .Also, the incidence of spontaneous abortion under 22 weeks , Continuous leakage of amniotic fluid , chorioamnionitis , uterine cramps and vaginal bleeding after the procedure will be studied.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510037676N3
Registration date:2015-10-29, 1394/08/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-29, 1394/08/07
Registrant information
Name
Simin Taghavi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
taghavisi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between 20G and 22G for second trimester amniocentesis in terms of technical aspects and short-term complications
Public title
Comparison between 20G and 22G for amniocentesis complications
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: single pregnancy;no history of cervical classic failure,hereditary or non-hereditary coagulation disorders, myoma,major fetal anomalies.
Exclusion criterion: withdrew from continuing the research
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Science
Street address
Golgasht Ave
City
Tabriz
Postal code
Approval date
2015-06-29, 1394/04/08
Ethics committee reference number
5/4/3714
Health conditions studied
1
Description of health condition studied
Detect of chromosal abnormalities
ICD-10 code
Q92.1
ICD-10 code description
تریزومی کروموزومی و موزائیسم
Primary outcomes
1
Description
Pain intencity
Timepoint
During amniocentesis
Method of measurement
VAS (Visual Analog Scale) system
Secondary outcomes
1
Description
Abortion under 22 weeks
Timepoint
Up to a week after amniocentesis
Method of measurement
During the phone call.The symptoms of bleeding and pain and miscarriage
2
Description
Vaginal bleeding
Timepoint
Up to a week after amniocentesis
Method of measurement
1-Less than menstrual bleeding 2-menstrual bleedingl.3- more than menstrual bleeding
3
Description
Continuous leakage of amniotic fluid
Timepoint
After 6 hours of amniocentesis to 1 week after the procedure
Method of measurement
Observation, ultrasound , nitrazine test
4
Description
Chorioamnionitis
Timepoint
Until a week after the procedure
Method of measurement
Uterine tenderness and maternal fever greater than 38°C
5
Description
Uterine cramps
Timepoint
After 6 hours of amniocentesis to 1 week after the procedure
Method of measurement
Uterine contractions felt by the patient
Intervention groups
1
Description
20 gauge needle will be used for Amniocentesis in group 1
Category
Diagnosis
2
Description
22 gauge needle will be used for Amniocentesis in group 2
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Teaching Hospital
Full name of responsible person
Barband Sharare
Street address
Baghshomal square
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Research deputy,Tabriz University OF medical Sciences,Golgasht Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Barband Sharare
Position
Medical student
Other areas of specialty/work
Street address
Golgasht Ave
City
Tabriz
Postal code
Phone
+98 41351665118
Fax
Email
salisheri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Taghavi Simin
Position
Associated prof of Ob & Gyn, fellowship of perinatalogy
Other areas of specialty/work
Street address
Golgasht Ave
City
Tabriz
Postal code
Phone
00
Fax
Email
Taghavisi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Barband Sharare
Position
Medical student
Other areas of specialty/work
Street address
Golgasht Ave
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)