ContraceptionNCT02679820
PostPlacental IUD Insertion
A study testing Copper T intrauterine device in people with Contraception, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
The immediate post cesarean section IUD insertion is a further step towards spreading more compliance to females in developing countries, with rapid increase in population size Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Copper T intrauterine device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Dec 2018
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females desiring contraception by using intrauterine device following their vaginal delivery or cesarean section
Who cannot join
- refusal to participate in the study
- desiring other methods of contraception
- will not use any method of contraception
- has a contraindication for the use of IUD as bicornuate or septate uterus, sub mucous myomas, etc.
Trial locations and contacts
1 site in 1 country.
About this study
The immediate post cesarean section IUD insertion is a further step towards spreading more compliance to females in developing countries, with rapid increase in population size
- Conditions
- Contraception
- Being tested
- Copper T intrauterine device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper T intrauterine deviceDevice
Also called copper T IUD
| Study group | Role | What they receive |
|---|---|---|
| PostPlacental IUD insertion | Experimental | Copper T intrauterine device will be inserted immediately following delivery of the placenta in cases of cesarean section deliveries. Receives: Device: Copper T intrauterine device |
| Control | No intervention | IUD will be offered as a method of contraception after puerperium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expulsion rate
Measured: 6 months
The percentage of females seeking contraception
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
- Investigators
- Dina MR Dakhly, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679820
- Sponsor's protocol ID
- LA010516
- Status last verified
- Jan 2019
- First submitted
- 8 Feb 2016
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Bayoumi YA, Dakhly DMR, Bassiouny YA, Gouda HM, Hassan MA, Hassan AA. Post-placental intrauterine device insertion vs puerperal insertion in women undergoing caesarean delivery in Egypt: a 1 year randomised controlled trial. Eur J Contracept Reprod Health Care. 2020 Dec;25(6):439-444. doi: 10.1080/13625187.2020.1823366. Epub 2020 Oct 2.
PubMed 33006501
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PostPlacental IUD Insertion
- ClinicalTrials.gov ID
- NCT02679820
- Acronym / sponsor ID
- LA010516
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Feb 2016 (estimated)
- 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.
The immediate post cesarean section IUD insertion is a further step towards spreading more compliance to females in developing countries, with rapid increase in population size
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PostPlacental IUD insertion | Experimental | Device: Copper T intrauterine deviceCopper T intrauterine device will be inserted immediately following delivery of the placenta in cases of cesarean section deliveries. |
| Control | No intervention | –IUD will be offered as a method of contraception after puerperium |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Females desiring contraception by using intrauterine device following their vaginal delivery or cesarean section
Key exclusion criteria (4 listed)
- refusal to participate in the study
- desiring other methods of contraception
- will not use any method of contraception
- has a contraindication for the use of IUD as bicornuate or septate uterus, sub mucous myomas, etc.
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 T intrauterine deviceAlso: copper T IUD | Device | PostPlacental IUD insertion |
Primary outcome
Expulsion rate
Time frame: 6 months
The percentage of females seeking contraception
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Derived from this study: PubMed 33006501Bayoumi YA, Dakhly DMR, Bassiouny YA, Gouda HM, Hassan MA, Hassan AA. Post-placental intrauterine device insertion vs puerperal insertion in women undergoing caesarean delivery in Egypt: a 1 year randomised controlled trial. Eur J Contracept Reprod Health Care. 2020 Dec;25(6):439-444. doi: 10.1080/13625187.2020.1823366. Epub 2020 Oct 2.
- Individual participant dataSharing planned: Undecided
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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.
Dina MR Dakhly, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copper T intrauterine device in people with Contraception, run by Woman's Health University Hospital, Egypt 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 9 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expulsion rate (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT02679820, which also lists 1 linked publication.
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 9 Jan 2019.