Home » Trials » SLCTR/2008/012


Efficacy of surgical versus expectant management in incomplete miscarriage

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SLCTR Registration Number

SLCTR/2008/012


Date of Registration

20 Jun 2008

The date of last modification

Jan 30, 2019


Trial Status



Application Summary


Scientific Title of Trial

Efficacy of surgical versus expectant management in incomplete miscarriage


Public Title of Trial

Effectiveness of surgery versus doing nothing in incomplete abortion


Disease or Health Condition(s) Studied

Incomplete miscarriage


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

None


Trial Details


What is the research question being addressed?

Effectiveness of surgical versus expectant management in incomplete miscarriage ?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Available


Intervention(s) planned

Randomise the study population into a surgical group where they will undergo evacuation of retained products of conception or an expectant group where they will be followed up weekly for six weeks clinically and using ultrasound of pelvis


Inclusion criteria

Women with an incomplete miscarriage with retained products less than 50mm AP diameter


Exclusion criteria

Women with a strong preference for either intervention, women with profuse bleeding, severe pain or fever necessitating immediate surgical intervention will be exclude from the study



Primary outcome(s)

  1. Compare the efficacy of surgical versus expectant management in incomplete miscarriage

    []

Secondary outcome(s)

  1. Compare the efficacy of surgical versus expectant management in incomplete miscarriage

    []

Target number/sample size

140


Countries of recruitment

Sri Lanka


Anticipated start date

2008-01-01


Anticipated end date

2009-06-30


Date of first enrollment


Date of study completion


Recruitment status

Complete: follow up complete


Funding source

National Science Foundation


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2006-03-16


Approval number

Not Available


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 & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr Sanjeewa Padumadasa
Probationary Lecturer
Faculty of Medicine, Ragama, Sri Lanka

0777 388 053
2958337
sanjeewapadumadasa@yahoo.com

Contact Person for Public Queries

Dr Sanjeewa Padumadasa
Probationary Lecturer
Faculty of Medicine, Ragama, Sri Lanka

0777 388 053
2958337
sanjeewapadumadasa@yahoo.com


Primary study sponsor/organization

National Science Foundation

47/5, Maitland Place, Colombo 7, Sri Lanka
2696771-3
2694754
info@nsf.ac.lk
www.nsf.ac.lk

Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not Available


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