Intrauterine Contraceptive Device ComplicationNCT05986344
Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device
An observational study of Intrauterine Contraceptive Device Complication, run by Beni-Suef University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Contraceptive Device Complication
- What is being tested?
- Copper intrauterine contraceptive device and LNG-IUS
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Desire to have intrauterine contraceptive device after counseling about different contraceptive options and consented to the study.
- Normal menstrual bleeding cycles (24-35 days).
Who cannot join
- 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
Show all 11Show fewer
- Known uterine anomalies e.g., Bicornuate/septate Uterus.
- Anemia (hemoglobin <10 g/dl).
- Diagnosis of active cervical infection
- Dysplasia in the cervix.
- Patients wishing post-partum or post-abortum IUD insertion
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
Official title: Correlation Between Uterine Artery Doppler Indices and Menstrual Changes After Insertion of Copper Intrauterine Contraceptive Device and Levonorgestrel Intrauterine System
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
Read the 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 .
- Being tested
- Copper intrauterine contraceptive device, LNG-IUS
- Keywords
- Intrauterine Contraceptive Device, Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper intrauterine contraceptive deviceDevice
Also called silverline
copper T-380 IUD
LNG-IUSDevice
Also called mirena
Levonorgestrel Intrauterine System
| Study group | Role | What they receive |
|---|---|---|
| Copper intrauterine contraceptive device | Women will have the copper T-380 IUD (silverline, imported by DKT Egypt LLC-Egypt) ® IUD. Receives: Device: Copper intrauterine contraceptive device | |
| Levonorgestrel Intrauterine System | Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD . Receives: Device: LNG-IUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
menstrual changes.
Pictorial blood loss assessment chart PBAC score (a score >100was equivalent to blood loss >80 mL)
Measured: 3 months after insertion
uterine artery pulsatility index
trans-vaginal ultrasound pulsed doppler
Measured: 3 months after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start30 Aug 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Contraceptive Device ComplicationStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
- Investigators
- Beni-Suef University, Principal investigator, Faculty of Medicine Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986344
- Sponsor's protocol ID
- Doppler IUD
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Uterine Artery Doppler Indices and Menstrual Changes After Insertion of Copper Intrauterine Contraceptive Device and Levonorgestrel Intrauterine System
- ClinicalTrials.gov ID
- NCT05986344
- Acronym / sponsor ID
- Doppler IUD
- Keywords
- Intrauterine Contraceptive Device, Doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copper intrauterine contraceptive device | – | Device: Copper intrauterine contraceptive deviceWomen will have the copper T-380 IUD (silverline, imported by DKT Egypt LLC-Egypt) ® IUD. |
| Levonorgestrel Intrauterine System | – | Device: LNG-IUSWomen will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD . |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Desire to have intrauterine contraceptive device after counseling about different contraceptive options and consented to the study.
- Normal menstrual bleeding cycles (24-35 days).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copper intrauterine contraceptive deviceAlso: silverlinecopper T-380 IUD | Device | Copper intrauterine contraceptive device |
| LNG-IUSAlso: mirenaLevonorgestrel Intrauterine System | Device | Levonorgestrel Intrauterine System |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beni-Suef University principal investigator
Faculty of Medicine Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Contraceptive Device Complication, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara A Salem, MD (01272842226 ext. 02, sara_abdallah100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
menstrual changes. (time frame: 3 months after insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.