Fibroids in Women of Reproductive Age a… | Clinical Trial

Key information

Conditions

Fibroids Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: Dydrogesterone M

Dydrogesterone M ( case 2 )

Drug

Dydrogesterone Multivitamin nature

Fibroids/ Women of Reproductive age ( discovered fibroids )
1tablet/24 hours/day ( from discovered fibroids through 6 months)

Other names: Dydrogesterone M

Primary outcomes

Measure of fibroid size in millimeters

Time frame: 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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Trieu, Nguyen Thi, M.D.

Indiv

Registry information

Official study 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

Acronym: Fibroids

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Dec 3, 2015
Registry last updated: Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed