Incomplete Abortion, Medical; Abortion, Fetus, Missed Abortion
Conditions
Keywords
miscarriages, first trimester, medical treatment
Brief summary
Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.
Detailed description
Women who are diagnosed with first trimester missed miscarriages are invited to participate in the study. They will be randomised to either gemeprost or dinoprostone.
Interventions
DRUGGemeprost 1 Mg Vaginal Pessary
Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours
Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours
Sponsors
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comparison between intravaginal gemeprost and dinoprostone.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* missed miscarriages * incomplete miscarriages * first trimester
Exclusion criteria
* coagulopathy * Rhesus negative * suspected ectopic pregnancy or pregnancy of unknown location * on anticoagulation drug * septic miscarriages * hemodynamically unstable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of women who achieved complete evacuation | from recruitment until up to one week after commencement of treatment | Complete expulsion of product of conception |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of women who experienced side effects | from recruitment until up to one week after commencement of treatment | side effects towards each drug such as fever, gastrointestinal upset |
Countries
Malaysia
Outcome results
None listed