- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02620345
Fibroids in Women of Reproductive Age and Women Pregnancy (Fibroids)
Uterine Fibroids Are a Very Common Finding in Women of Reproductive Age. Ready Safety Study Dydrogesterone + Multivitamin Nature in Women of Reproductive Age and Women Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Uterine fibroids are a very common finding in women of reproductive age. But may fibroids grow in the first trimester pregnancy.
Clinically has shown that:
Uterine fibroids are associated with an Heavy or prolonged menstrual periods. Abnormal bleeding between menstrual periods.
Uterine fibroids are associated with an increased rate of spontaneous miscarriage, preterm labor, placenta abruption, malpresentation, labor dystocia, cesarean delivery, and postpartum hemorrhage, pain is the most common complication of fibroids during pregnancy. Can usually be controlled by conservative treatment on Dydrogesterone Multivitamin nature.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Procedure to treatment of fibroids in pregnancy and in women desiring future fertility.
Exclusion Criteria:
- Whether or not you are having symptoms from the fibroids
- If you might want to become pregnant in the future
- The size of the fibroids
- The location of the fibroids
- Your age and you might be
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dydrogesterone M/ Women Pregnancy
|
Dydrogesterone Multivitamin nature
Other Names:
|
Experimental: Dydrogesterone M/ Reproductive Age
|
Dydrogesterone Multivitamin nature
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of fibroid size in millimeters
Time Frame: from 4 weeks to 20 weeks
|
Group (A): Women Pregnancy.
Group (B): Women Reproductive age.
|
from 4 weeks to 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of fibroid size in millimeters
Time Frame: from 20 weeks to 48 weeks
|
Group (A):Women Pregnancy. - Measure of fibroid size in millimeters to loss the fibroids. Group (B): Women Reproductive age - Measure of fibroid size in millimeters to loss the fibroids. |
from 20 weeks to 48 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nguyen Thi Trieu, Master, Tran Minh Duc, Dr.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dydrogesterone Multivitamin
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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