Fibroids in Women of Reproductive Age and Women Pregnancy

Phase 4

Completed

• Conditions: Fibroids
• Interventions: Drug: Dydrogesterone M ( case 2 ); Drug: Dydrogesterone M ( case 1 )

• Registration Number: NCT02620345
• Lead Sponsor: Trieu, Nguyen Thi, M.D.

Brief Summary

Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and women pregnancy to lost the size fibroids.

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2015-10
• Status Verified: 2015-11
• Study Completion: 2015-11
• Study First Submitted: 2015-11-14
• Study First Submitted QC: 2015-11-30
• Last Update Submitted: 2015-11-30
• Study First Posted: 2015-12-03
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dydrogesterone M/ Reproductive Age	Dydrogesterone M ( case 2 )	* 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.
Dydrogesterone M/ Women Pregnancy	Dydrogesterone M ( case 1 )	* 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.

Primary Outcome Measures

Name	Time	Method
Measure of fibroid size in millimeters	from 4 weeks to 20 weeks	* 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.

Secondary Outcome Measures

Name	Time	Method
Measure of fibroid size in millimeters	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.