| Scientific Title of Trial | Surgical treatment vs expectant care in the management of incomplete miscarriage | |
| Public Title of Trial (in lay language) | Is evacuation of retained products of conception routinely required for incomplete miscarriage? | |
| Acronym, if any | Nil | |
| Brief title, if any | Nil | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
Nil | |
| Disease or Health Condition(s) studied | First trimester incomplete miscarriage | |
| 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? | |
| Study design | Randomized controlled trial without blinding | |
| 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 | |
| Target number / sample size | 144 | |
| Primary outcome(s) | In the study group percentage reduction in the population of women with incomplete miscarriages who will require a surgical evacuation | |
| Primary outcome(s) - time of assessment(s) | ||
| 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 | |
| Secondary outcome(s) - time of assessment(s) | ||
| Countries of recruitment | Nil | |
| Anticipated start date | 24/03/2008 | |
| Anticipated end date | 23/02/2009 | |
| Recruitment status | Completed | |
| State of ethics review approval | Approved by Ethical Review Committee of the Faculty of Medicine, Galle | |
| Funding source(s) | Nil | |
| Applicant's Email | malikg@eureka.lk | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Prof. Malik Goonewardene
Professor & Head Dept. of Obstetrics & Gynaecology, Faculty of Medicine, Galle. (091)2246878, 2234801/3 (091)2222314 malikg@eureka.lk |
|
| Primary Study Sponsor/ Organization | Faculty of Medicine
Dept. of Obstetrics & Gynaecology (091)2246878, 2234801/3 (091)2222314 |
|
| Contact Person for Public Queries | Prof. Malik Goonewardene Professor & Head of Dept. Dept. of Obstetrics & Gynaecology, Faculty of Medicine, Galle + 94 91 2246878, 2234801/ 3 2234730 + 94 91 2222314 malikg@eureka.lk |
|
| Secondary Study Sponsor(s), (if any) | Nil |
|
