Home » Trials » SLCTR/2008/011


Surgical treatment vs expectant care in the management of incomplete miscarriage

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SLCTR Registration Number

SLCTR/2008/011


Date of Registration

20 Jun 2008

The date of last modification

Jan 30, 2019


Trial Status



Application Summary


Scientific Title of Trial

Surgical treatment vs expectant care in the management of incomplete miscarriage


Public Title of Trial

Is evacuation of retained products of conception routinely required for incomplete miscarriage?


Disease or Health Condition(s) Studied

First trimester 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?

Can expectant care in the management of incomplete miscarriage safely reduce the need for surgical interventions without significantly increasing any adverse effects?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Available


Intervention(s) planned

Not carrying out surgical evacuation in the study group and routine surgical evacuation in the control group


Inclusion criteria

Consecutive women presenting within three (3) days of bleeding with spontaneous miscarriage at a period of gestation of 14 weeks or less and trans vaginal ultrasound diameter of retained products of conception between 15 mm to 50 mm


Exclusion criteria

Women who have strong preference to either management, any other complicating medical conditions, cervical incompetence and induced abortions and evidence of induced abortion



Primary outcome(s)

  1. In the study group percentage reduction in the population of women with incomplete miscarriages who will require a surgical evacuation

    []

Secondary outcome(s)

  1. Excessive bleeding, need for surgical evacuation, infections, pain, cervical or uterine injuries, duration of vaginal bleeding, time off normal work, duration of hospital stay

    []

Target number/sample size

144


Countries of recruitment

Sri Lanka


Anticipated start date

2008-03-24


Anticipated end date

2009-02-23


Date of first enrollment


Date of study completion


Recruitment status

Complete: follow up complete


Funding source

None


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2008-01-14


Approval number

Not Available


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Ruhuna
Institutional Address: PO Box 70, Labuduwa Rd, Galle, Sri Lanka
Telephone: +94-91-2234801/803 (Extension: 161)
Email: ethics@med.ruh.ac.lk


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Prof. Malik Goonewardene
Professor & Head, Department of Obstetrics & Gynaecology
Faculty of Medicine, Galle.
(091)2246878, 2234801/3

(091)2222314
malikg@eureka.lk

Contact Person for Public Queries

Prof. Malik Goonewardene
Professor & Head, Department of Obstetrics & Gynaecology
Faculty of Medicine, Galle.
(091)2246878, 2234801/3

(091)2222314
malikg@eureka.lk


Primary study sponsor/organization

Dept. of Obstetrics & Gynaecology

Faculty of Medicine, Galle.
(091)2246878, 2234801/3
(091)2222314

Secondary study sponsor (If any)

None





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