Fibroids in Women of Reproductive Age and Women Pregnancy | NCT02620345

NCT02620345

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dydrogesterone M/ Women Pregnancy	Experimental	Reducing the size of fibroids with medication Drug: Dydrogesterone M 15mg/Fibroids/Women Pregnancy Dosage: 1tablet/24 hours/day/ (when seeing fibroids to 4 weeks after postpartum). Dydrogesterone 15mg/day Beta Carotene 4000 IU/day Ascorbic Acid 100 mg/day Cholecalciferol 400 IU/day Dl-Alpha Tocopheryl Acetate 11IU Thiamin Mononitrate 1.5 mg/day Riboflavin 1.7 mg/day Niacinamide 18 mg/day Pyridoxine Hydrochloride 2.6 mg/day Folic Acid 400 mcg/day Cyanocobalamin 4mcg/day Calcium Carbonate 150 mg/day Ferrous Fumarate 27 mg/day Zinc Oxide 25 mg/day The lost in size of fibroids throughout pregnancy after 48 weeks.	Drug: Dydrogesterone M ( case 1 )
Dydrogesterone M/ Reproductive Age	Experimental	Reducing the size of fibroids with medication Drug: Dydrogesterone M 15mg/Fibroids/Reproductive Age Dosage: 1tablet/24 hours/day/24 weeks ( from discovered fibroids through 24 weeks). Dydrogesterone 15mg/day Beta Carotene 4000 IU/day Ascorbic Acid 100 mg/day Cholecalciferol 400 IU/day Dl-Alpha Tocopheryl Acetate 11IU Thiamin Mononitrate 1.5 mg/day Riboflavin 1.7 mg/day Niacinamide 18 mg/day Pyridoxine Hydrochloride 2.6 mg/day Folic Acid 400 mcg/day Cyanocobalamin 4mcg/day Calcium Carbonate 150 mg/day Ferrous Fumarate 27 mg/day Zinc Oxide 25 mg/day The lost in size of fibroids after 24 weeks.	Drug: Dydrogesterone M ( case 2 )

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dydrogesterone M ( case 1 )	Drug	Dydrogesterone Multivitamin nature Fibroids / Women Pregnancy ( discovered fibroids during pregnancy ) Dydrogesterone Multivitamin nature. 1tablet/24 hours/day (to 4 weeks after postpartum)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of fibroid size in millimeters	Patients fulfilling inclusion and exclusion criteria. Measure to have Fibroids size > 50mm x 60mm. Will be divided into two groups Group (A): Women Pregnancy. Measure of fibroid size in millimeters < 50mm x 60mm. Group (B): Women Reproductive age. Measure of fibroid size in millimeters < 50mm x 60mm.	from 4 weeks to 20 weeks

Secondary Outcomes

Measure	Description	Time Frame
Measure of fibroid size in millimeters	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

Eligibility Module

Label	URL
Contemporary Management of Fibroids in Pregnancy	View source
What is the treatment for uterine fibroids?	View source

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 13, 2018			Dec 5, 2018
Dec 12, 2018

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms