Heavy periods is a significant problem in reproductive age .It affects about a third of women in the childbearing period Any of the following is considered to be heavy menstrual bleeding (Bleeding that lasts more than 7 days,Bleeding that soaks through one or more tampons or pads every hour for several hours in a row.Needing to wear more than one pad at a time to control menstrual flow.,Needing to change pads or tampons during the night or Menstrual flow with blood clots that are as big as a quarter or larger) . Heavy periods can be caused by organic cause as fibroids, adenomyosis, polyps or they can be dysfunctional.Dysfunctional uterine bleeding is irregular uterine bleeding that occurs in the absence of recognisable pelvic pathology, general medical disease, or pregnancy. It reflects a disruption in the normal cyclic pattern of ovulatory hormonal stimulation to the endometrial lining. Several treatment options include: hormonal treatment as norethisterone acetate,oral contraceptive pills, gonadotrophin releasing hormone analogue. ,tranexamic acid or non steroidal anti-inflammatory drugs. The investigators plan to do a comparative study between norethisterone acetate and tranexamic acid regarding their control of the heavy periods as well as their effect on the uterine and endometrial vasculature.
This is a Randomised controlled trial.The investigators will randomise 120 women who suffer from heavy periods (age range 35-49 years old) without organic cause (Dysfunctional bleeding ) into 2 groups, group A (60 women) : They will take norethisterone acetate 15 mg daily from day 5 to day 26 of the period for 3 months. Group B (60 women): They will take 1 gm tranexemic acid three times daily from the start of menstrual period up to 5 days.The dose might be increased per day (Not more than 4 gm per day). The investigators will check endometrial thickness, endometrial volume, uterine artery Doppler indices as well as endometrial and subendometrial indices before starting the treatment and 3 months afterwards.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
norethisterone acetate 15 mg daily from day 5 of the cycle to day 26.
tranexemic acid 1 gm three times daily from the first day of the menstrual cycle up to 5 days .The dose can be increased but not exceeding 4 gm per day.
reducion of the menstrual flow.
Using Pictorial Blood loss assessment chart depends on counting the sanitary pads and scoring the amount of blood in them)
Time frame: 3 months
endometrial thickness in centimetre.
Measurement of the thickest part of the endometrium in centimetres in the longitudinal plan of the uterus using Two- Dimensional Transvaginal ultrasound
Time frame: Before the intervention and 3 months afterwards
endometrial volume in cubic centimetre.
Measurement of the endometrial volume in cubic centimetres using Three-Dimensional transvaginal ultrasound
Time frame: Before the intervention and 3 months afterwards
uterine artery Doppler indices.
Measurement of the uterine artery Doppler indices using Transvaginal ultrasound and taking the mean for both arteries.
Time frame: Before the intervention and 3 months afterwards
endometrial three-dimensional vascular indices.
Measuring the vascularity in the endometrium using power doppler and Three -Dimensional transvaginal ultrasound.
Time frame: Before the intervention and 3 months afterwards
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