Home » Trials » SLCTR/2014/022
Randomised controlled trial to assess the retention of immediate post-delivery insertion of an intrauterine contraceptive device versus interval intrauterine contraceptive device insertion
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SLCTR Registration Number
SLCTR/2014/022
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Randomised controlled trial to assess the retention of immediate post-delivery insertion of an intrauterine contraceptive device versus interval intrauterine contraceptive device insertion
Public Title of Trial
Success of intrauterine contraceptive device retention just after the delivery
Disease or Health Condition(s) Studied
Contraception
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1155-3985
Any other number(s) assigned to the trial and issuing authority
P/162/08/2014 (Ethics Review Committee, Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
What is the rate of successful retention of the copper intrauterine device (IUD) when inserted within 10 minutes of placental delivery, compared to insertion at 6–8 weeks postpartum?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Participants will be randomized at admission to receive either immediate post-placental or interval IUD insertion. The participants will be offered an ultrasound scan and 12 hours and at 6-8 weeks postpartum.
Expelled IUDs will be replaced according to patient preference.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Retention of IUD within uterine cavity |
[ At 12 hours of insertion and at 6-8 weeks post partum ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
86
Countries of recruitment
Sri Lanka
Anticipated start date
2014-11-01
Anticipated end date
2014-05-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2014-08-06
Approval number
P/162/08/2014
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Tiran Dias
Consultant Obstetrician and Gynaecologist
Senior Lecturer, Department of Obstetrics and Gynaecology, Faculty of Medicine University of Kelaniya Sri Lanka
0094773051142
thiran_dias@yahoo.com
Contact Person for Public Queries
Dr Tiran Dias
Consultant Obstetrician and Gynaecologist
Senior Lecturer, Department of Obstetrics and Gynaecology, Faculty of Medicine University of Kelaniya Sri Lanka
0094773051142
thiran_dias@yahoo.com
Primary study sponsor/organization
District General Hospital, Ampara
Postal Code 32000,
Ampara,
Sri Lanka
+94632222261
+94632222261
ghampara@gmail.com
http://www.ghampara.gov.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
