|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
SLCTR |
|
Last refreshed on:
|
27 April 2013 |
|
Main ID: |
SLCTR/2008/011 |
|
Date of registration:
|
20/06/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Is evacuation of retained products of conception routinely required for incomplete miscarriage?
|
|
Scientific title:
|
Surgical treatment vs expectant care in the management of incomplete miscarriage |
|
Date of first enrolment:
|
24/3/2008 |
|
Target sample size:
|
144 |
|
Recruitment status: |
Completed |
|
URL:
|
http://www.slctr.lk/trial_details.asp?reg_id={C97BBF65-630A-45E3-ACEF-6BFA91C4F4AB} |
|
Study type:
|
Interventional |
|
Study design:
|
Randomized controlled trial without blinding
|
|
|
Countries of recruitment
|
|
Nil
| | | | | | | |
|
Contacts
|
|
Name:
|
Prof. Malik Goonewardene
|
|
Address:
|
Dept. of Obstetrics and Gynaecology, Faculty of Medicine, Galle
|
|
Telephone:
|
+ 94 91 2246878, 2234801/ 3 2234730 |
|
Email:
|
malikg@eureka.lk |
|
Affiliation:
|
Professor and Head of Dept. |
|
|
Name:
|
Prof. Malik Goonewardene
|
|
Address:
|
Dept. of Obstetrics and Gynaecology, Faculty of Medicine, Galle.
|
|
Telephone:
|
(091)2246878, 2234801/3 |
|
Email:
|
malikg@eureka.lk |
|
Affiliation:
|
Professor and Head |
| |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
First trimester incomplete miscarriage
|
|
Intervention(s)
|
|
Not carrying out surgical evacuation in the study group and routine surgical evacuation in the control group
|
|
Primary Outcome(s)
|
|
In the study group percentage reduction in the population of women with incomplete miscarriages who will require a surgical evacuation
|
|
Secondary Outcome(s)
|
|
Excessive bleeding, need for surgical evacuation, infections, pain, cervical or uterine injuries, duration of vaginal bleeding, time off normal work, duration of hospital stay
|
|
Source(s) of Monetary Support
|
|
Nil
|
|