Back to resultsGemeprost Versus Dinoprostone in First Trimester Miscarriages
Primary Purpose
Missed Abortion, Medical; Abortion, Fetus, Incomplete Abortion
Status
Recruiting
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Gemeprost 1 Mg Vaginal Pessary
Dinoprostone 3 mg
Sponsored by
About this trial
This is an interventional treatment trial for Missed Abortion focused on measuring miscarriages, first trimester, medical treatment
Eligibility Criteria
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
Sites / Locations
- UKM Medical CenterRecruiting
- UKM Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Gemeprost
Dinoprostone
Arm Description
Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours.
Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours.
Outcomes
Primary Outcome Measures
Percentage of women who achieved complete evacuation
Complete expulsion of product of conception
Secondary Outcome Measures
Percentage of women who experienced side effects
side effects towards each drug such as fever, gastrointestinal upset
Full Information
NCT ID
NCT05342467
First Posted
April 17, 2022
Last Updated
April 25, 2022
Sponsor
National University of Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT05342467
Brief Title
Gemeprost Versus Dinoprostone in First Trimester Miscarriages
Official Title
Gemeprost Versus Dinoprostone in the Medical Management of First Trimester Miscarriages: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University of Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missed Abortion, Medical; Abortion, Fetus, Incomplete Abortion
Keywords
miscarriages, first trimester, medical treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Comparison between intravaginal gemeprost and dinoprostone.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gemeprost
Arm Type
Active Comparator
Arm Description
Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours.
Arm Title
Dinoprostone
Arm Type
Active Comparator
Arm Description
Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours.
Intervention Type
Drug
Intervention Name(s)
Gemeprost 1 Mg Vaginal Pessary
Intervention Description
Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours
Intervention Type
Drug
Intervention Name(s)
Dinoprostone 3 mg
Intervention Description
Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours
Primary Outcome Measure Information:
Title
Percentage of women who achieved complete evacuation
Description
Complete expulsion of product of conception
Time Frame
from recruitment until up to one week after commencement of treatment
Secondary Outcome Measure Information:
Title
Percentage of women who experienced side effects
Description
side effects towards each drug such as fever, gastrointestinal upset
Time Frame
from recruitment until up to one week after commencement of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rahana Abd Rahman
Phone
+60122719985
Email
drrahana@ppukm.ukm.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
Aida Hani Kalok
Phone
+60122024091
Email
aidahani.mohdkalok@ppukm.ukm.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rahana Abd Rahman
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UKM Medical Center
City
Kuala Lumpur
State/Province
W.Persekutuan
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahana Abd Rahman
Phone
+60122719985
Email
drrahana@ppukm.ukm.edu.my
Facility Name
UKM Medical Centre
City
Kuala Lumpur
State/Province
W.Persekutuan
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahana Abd Rahman
Phone
+60122719985
Email
drrahana@ppukm.ukm.edu.my
First Name & Middle Initial & Last Name & Degree
Aida Hani Kalok
Phone
+60122024091
Email
aidahani.mohdkalok@ppukm.ukm.edu.my
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Gemeprost Versus Dinoprostone in First Trimester Miscarriages
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