Correlation Between Uterine Artery Doppler Indices and Menstrual Changes After Insertion of Copper Intrauterine Contraceptive Device and Levonorgestrel Intrauterine System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intrauterine Contraceptive Device Complication
- Sponsor
- Beni-Suef University
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- menstrual changes.
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
To evaluate the correlation between uterine artery Doppler indices and subsequent menstrual changes after 3 months of insertion of copper T-380 IUD and LNG-IUS
Detailed Description
A randomized prospective clinical trial Study Population: The study population includes multiparous women, having normal menstrual cycles, who are eligible for insertion of IUCD. Women will be recruited for enrollment when they come to the family planning clinic. They will be counseled about different contraceptive options. If they want to have the IUCD, they will be asked to participate in the study after been evaluated to ensure fulfilling inclusion and exclusion criteria Women will be enrolled in the study after giving written informed consent Group (A): ....Women will have the copper T-380 IUD (PREGNA, India, imported by DKT Egypt LLC-Egypt) ® IUD. Group (B): .... Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD .
Investigators
Sara Abdallah Mohamed Salem
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University
Eligibility Criteria
Inclusion Criteria
- •Desire to have intrauterine contraceptive device after counseling about different contraceptive options and consented to the study.
- •Normal menstrual bleeding cycles (24-35 days).
Exclusion Criteria
- •Nulliparity.
- •Undiagnosed uterine bleeding.
- •Any proven ovarian, uterine or endometrial pathology such as; uterine myoma, adenomyosis, endometrial polyps, ovarian cysts
- •Contraceptive pills had not been taken during the previous 3 months and any previous IUD had been removed at least 1 month earlier
- •Hemorrhagic disorders.
- •Acute or chronic pelvic inflammatory disease
- •Known uterine anomalies e.g., Bicornuate/septate Uterus.
- •Anemia (hemoglobin \<10 g/dl).
- •Diagnosis of active cervical infection
- •Dysplasia in the cervix.
Outcomes
Primary Outcomes
menstrual changes.
Time Frame: 3 months after insertion
Pictorial blood loss assessment chart PBAC score (a score \>100was equivalent to blood loss \>80 mL)
uterine artery pulsatility index
Time Frame: 3 months after insertion
trans-vaginal ultrasound pulsed doppler