IUDNCT05283798
Insertion of Copper T380 Versus Multiload IUD Post Partum
A study testing IUD in people with IUD, run by Mahmoud Abdelhameed Hussien Soliman.
Trial summary
To compare efficacy safety \& side effects of multiload 375 IUD versus copper T 380 IUD when inserted during elective CS Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD
- What is being tested?
- IUD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Dec 2023
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women delivered by elective CS ≥ 36 wks
Who cannot join
- Patients with PROM Patients on corticosteroids therapy Patients on anticoagulant patients who refuse participate in the study with written consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Postpartum Intra-caesarean Section Insertion of Copper T380 Versus Multiload 375 IUD in a Randomized Controlled Trial.
To compare efficacy safety \& side effects of multiload 375 IUD versus copper T 380 IUD when inserted during elective CS
Read the detailed description
Insertion of an intrauterine device (IUD) immediately after delivery is appealing for several reasons. The woman is known not to be pregnant, her motivation for contraception may be high, and the setting may be convenient for both the woman and her provider The World Health Organization (WHO) recommends that a woman should wait at least 24 months after delivery before the next pregnancy to decrease the adverse maternal, perinatal ,and infant outcomes.
Compared with other contraceptive methods, early post-partum IUD insertion has several advantages. It provides immediate contraception without interfering with breast feeding, and it may avoid discomfort related to insertion. Inserting an IUD immediately after placental removal has not been associated with increased infection, uterine perforation, postpartum bleeding, or uterine subinvolution . The expulsion rate is higher (approximately 12% in the first postpartum year) after immediate postpartum insertion compared to insertion 4 to 8 weeks later. Continuation rates are relatively high (87.6% and 76.3%, at 6 and 12 months, respectively Studies have shown that with effective provider training, the immediate postpartum IUD insertion (IPPIUD) complications such as expulsion, pelvic infection, bleeding, pain, missing threads ,and failure rates are not significantly different from those of interval PPIUD insertion (4:6 weeks) after delivery
- Conditions
- IUD
- Being tested
- IUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUDDevice
Postpartum intra-caesarean section insertion of copper T380 versus multiload 375
| Study group | Role | What they receive |
|---|---|---|
| rate of missed threads in the first 6 weeks | Experimental | To compare efficacy safety \& side effects of multiload 375 IUD versus copper T 380 IUD when inserted during elective CS Receives: Device: IUD |
| number of bleeding days in first 6 weeks | Other | compare numbers of bleeding days in first 6 weeks and first 6 month Receives: Device: IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
expulsion rate after 6 weeks of insertion
compare expulsion rates between the two types after 6 weeks by ultrasoud
Measured: 6 weeks
Secondary outcomes (1)
compare bleedind dayes and shift to anthor methoud
- - number of bleeding days in the 1st 6 weeks
- - number of bleeding days in each month in the 1st 6 months
- compare by US between the 2 types
- - the shift into another method and what is it
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study startAug 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUDStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Abdelhameed Hussien Soliman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Abdelhameed Hussien Soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283798
- Sponsor's protocol ID
- intra cs IUD
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Intra-caesarean Section Insertion of Copper T380 Versus Multiload 375 IUD in a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05283798
- Acronym / sponsor ID
- intra cs IUD
- Conditions
- IUD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mahmoud Abdelhameed Hussien SolimanUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Mar 2022 (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 compare efficacy safety \& side effects of multiload 375 IUD versus copper T 380 IUD when inserted during elective CS
Detailed description
Insertion of an intrauterine device (IUD) immediately after delivery is appealing for several reasons. The woman is known not to be pregnant, her motivation for contraception may be high, and the setting may be convenient for both the woman and her provider The World Health Organization (WHO) recommends that a woman should wait at least 24 months after delivery before the next pregnancy to decrease the adverse maternal, perinatal ,and infant outcomes.
Compared with other contraceptive methods, early post-partum IUD insertion has several advantages. It provides immediate contraception without interfering with breast feeding, and it may avoid discomfort related to insertion. Inserting an IUD immediately after placental removal has not been associated with increased infection, uterine perforation, postpartum bleeding, or uterine subinvolution . The expulsion rate is higher (approximately 12% in the first postpartum year) after immediate postpartum insertion compared to insertion 4 to 8 weeks later. Continuation rates are relatively high (87.6% and 76.3%, at 6 and 12 months, respectively Studies have shown that with effective provider training, the immediate postpartum IUD insertion (IPPIUD) complications such as expulsion, pelvic infection, bleeding, pain, missing threads ,and failure rates are not significantly different from those of interval PPIUD insertion (4:6 weeks) after delivery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rate of missed threads in the first 6 weeks | Experimental | Device: IUDTo compare efficacy safety \& side effects of multiload 375 IUD versus copper T 380 IUD when inserted during elective CS |
| number of bleeding days in first 6 weeks | Other | Device: IUDcompare numbers of bleeding days in first 6 weeks and first 6 month |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women delivered by elective CS ≥ 36 wks
Key exclusion criteria (1 listed)
- Patients with PROM Patients on corticosteroids therapy Patients on anticoagulant patients who refuse participate in the study with written consent
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 |
|---|---|---|
| IUDPostpartum intra-caesarean section insertion of copper T380 versus multiload 375 | Device | number of bleeding days in first 6 weeks, rate of missed threads in the first 6 weeks |
Primary outcome
expulsion rate after 6 weeks of insertion
Time frame: 6 weeks
compare expulsion rates between the two types after 6 weeks by ultrasoud
1 secondary outcome
compare bleedind dayes and shift to anthor methoud
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing IUD in people with IUD, run by Mahmoud Abdelhameed Hussien Soliman.
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 1 inclusion and 1 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 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Mahmoud Abdelhameed (01096128561, m7moud3bdel7ameed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expulsion rate after 6 weeks of insertion (time frame: 6 weeks). 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 17 Mar 2022.