Fibroids in Women of Reproductive Age and Women Pregnancy

Fibroids Clinical Trial

— Fibroids  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620345
• Other study ID #: Dydrogesterone Multivitamin
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2015
• Last updated: November 30, 2015
• Start date: January 2010
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Triê?u, Nguyê~n Thi?, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ho Chi Minh City Health Service
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibroids
• Leiomyoma

Intervention

Drug:
• Dydrogesterone M ( case 1 )
Dydrogesterone Multivitamin nature Fibroids / Women Pregnancy ( discovered fibroids during pregnancy ) Dydrogesterone Multivitamin nature. 1tablet/24 hours/day (to 4 weeks after postpartum)
• Dydrogesterone M ( case 2 )
Dydrogesterone Multivitamin nature Fibroids/ Women of Reproductive age ( discovered fibroids ) 1tablet/24 hours/day ( from discovered fibroids through 6 months)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Triê?u, Nguyê~n Thi?, M.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes

External Links

•   Contemporary Management of Fibroids in Pregnancy
•   What is the treatment for uterine fibroids?