Home » Trials » SLCTR/2014/010
Prophylactic use of antibiotic (doxycycline) for incomplete and missed miscarriage, prior to medical and surgical management
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SLCTR Registration Number
SLCTR/2014/010
Date of Registration
The date of last modification
Apr 30, 2019
Trial Status
Scientific Title of Trial
Prophylactic use of antibiotic (doxycycline) for incomplete and missed miscarriage, prior to medical and surgical management
Public Title of Trial
A study on antibiotic use to prevent infections after miscarriage
Disease or Health Condition(s) Studied
Incomplete and missed 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
What is the research question being addressed?
What is the effectiveness of prophylactic doxycycline use compared to placebo, given prior to surgical and medical evacuation of incomplete and missed miscarriage, in decreasing post-operative pelvic infection?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Placebo
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 4
Intervention(s) planned
Prospective participants presenting to the study setting will be evaluated by the Principal Investigator. Medical or surgical management will be decided on the following criteria
1) Patients presenting with per vaginal bleeding, os-open, Trans vaginal ultrasound (TVS) detecting incomplete miscarriage will be selected to receive surgical evacuation or medical evacuation depending on patient preference. If medical management fails, surgical evacuation will be offered.
2) Patients diagnosed with missed miscarriage, os- closed with compatible TVS findings will be offered medical management. If medical management fails, surgical evacuation will be offered.
Once management has been decided, consenting participants meeting the inclusion/exclusion criteria will be recruited for the study. Stratified randomization with computer generated random numbers will be used to allocate participants to two arms.
The intervention arm will receive a single oral dose of doxycycline 200mg one hour prior to intervention. The control arm will receive an inert placebo, with identical appearance to doxyclycline.
Other interventions such as dilatation & curettage, vacuum aspiration/suction evacuation, medical management with vaginal prostaglandin use and blood transfusion will be provided to both arms as indicated.
Inclusion criteria
Woman who present to ward NO: 03, T.H .Peradeniya (Gynaecology Professorial Unit) with incomplete and missed miscarriage diagnosed by Trans vaginal ultrasound as below:
1. Incomplete miscarriage: thickness of products of conception is > 1.5 cm
2. Missed miscarriage: Gestational sac >25mm without fetal pole or fetal pole CRL> 7mm without heart beat
Exclusion criteria
Signs and symptoms of infection including • Temperature > 37 0C • Lower abdominal tenderness • Offensive vaginal discharge • Cervical excitation
Known allergy to doxycycline
POG=/< than 24 weeks.
Primary outcome(s)
|
1.
Clinical signs of infection (at least 3 of the following)
|
[ At completion of three days and at 2 weeks post intervention ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
280 (140 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2014-05-26
Anticipated end date
2014-12-31
Date of first enrollment
2014-05-26
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2013-12-10
Approval number
N/A
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. D.P.G.G.M. Prasanga
Registrar, Gynaecology and Obstetrics
Professorial Unit, Teaching Hospital, Peradeniya.
0772988313
prasangagayan@yahoo.com
Contact Person for Public Queries
Dr C Rathnayake
Consultant Obstetrician and Gynaecologist and Senior Lecturer in Obstetrics and Gynaecology
Faculty of Medicine, University of Peradeniya
0777792616
chathura.ratnayake@gmail.com
Primary study sponsor/organization
University Obstetrics and Gynaecology Unit,
Faculty of Medicine, University of Peradeniya
Tel: 081-2388840
Fax :081-2389106
http://www.pdn.ac.lk/med/departments/gyn&obs/index.html
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
