Gemeprost Versus Dinoprostone in First Trimester Miscarriages

Study Overview
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Brief Summary
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Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

Detailed Description
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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.

Official Title
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Gemeprost Versus Dinoprostone in the Medical Management of First Trimester Miscarriages: a Randomized Controlled Study

Conditions
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Missed Abortion, Medical; Abortion, Fetus, Incomplete Abortion

Intervention / Treatment
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* Drug: Gemeprost 1 Mg Vaginal Pessary
* Drug: Dinoprostone 3 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison between intravaginal gemeprost and dinoprostone.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gemeprost<br>Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours. | Drug: Gemeprost 1 Mg Vaginal Pessary<br>* Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours<br>Drug: Dinoprostone 3 mg<br>* Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours<br>|
| Active Comparator: Dinoprostone<br>Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours. | Drug: Gemeprost 1 Mg Vaginal Pessary<br>* Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours<br>Drug: Dinoprostone 3 mg<br>* Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women who achieved complete evacuation | Complete expulsion of product of conception | from recruitment until up to one week after commencement of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women who experienced side effects | side effects towards each drug such as fever, gastrointestinal upset | from recruitment until up to one week after commencement of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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miscarriages, first trimester, medical treatment