Intrauterine Device MigrationNCT03780985
Post-placental Intrauterine Device Insertion During Cesarean Section
A study testing Intrauterine device insertion, Cesarean section and Suture in people with Intrauterine Device Migration, run by Assiut University at 1 site in Egypt.
Trial summary
Effective, reversible postpartum contraception decreases the chance of rapid repeat pregnancy and poor perinatal outcome in a subsequent pregnancy especially in women delivered by cesarean section.The traditional 6-week postpartum visits not evidenced based and may not meet patient needs, particularly with respect to… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Device Migration
- What is being tested?
- Intrauterine device insertion, Cesarean section and Suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Apr 2020
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age group : 18-40 years
- Women who will be willing to undergo elective cesarean section
- women desire using Copper IUD as long acting contraceptive method.
Who cannot join
- Intrauterine infection.
- Fundal Myoma.
- Hemorrhagic disorder
- Genital tract malignancy
- Uterine atony
- Sexually transmitted infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hang-up Versus Non-fixation Technique for Immediate Post-placental Intrauterine Device Insertion During Cesarean Section
Effective, reversible postpartum contraception decreases the chance of rapid repeat pregnancy and poor perinatal outcome in a subsequent pregnancy especially in women delivered by cesarean section.The traditional 6-week postpartum visits not evidenced based and may not meet patient needs, particularly with respect to provision of contraception.Intrauterine device placement after delivery of the placenta is an appealing strategy for increasing access to postpartum Intrauterine device because it does not require a separate postpartum visit.
Advantage of post-placental Intrauterine device insertion, Intrauterine devices are recommended as first-line contraceptives by the American Academy of Pediatricians. The Centers for Disease Control and Prevention united state . Medical Eligibility Criteria for Contraceptive Use places no restrictions on use, and states advantages generally outweigh the risks for immediate postpartum use of Intrauterine devices.
- Conditions
- Intrauterine Device Migration
- Being tested
- Intrauterine device insertion, Cesarean section, Suture
- Medical subject headings
- Intrauterine Device Migration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine device insertionProcedure or surgery
Post-placental insertion of intrauterine device during Cesarean section
Cesarean sectionProcedure or surgery
to delivery of the fetus
SutureProcedure or surgery
to fix the intrauterine device
| Study group | Role | What they receive |
|---|---|---|
| intrauterine device insertion with a suture fixation | Active comparator | Intruterine device through hysterotomy incision during cesarean section with a suture fixation Receives: Procedure: Intrauterine device insertion; Procedure: Cesarean section; Procedure: Suture |
| intrauterine device insertion without a suture fixation | Active comparator | IUD through hysterotomy incision during cesarean section without a suture fixation Receives: Procedure: Intrauterine device insertion; Procedure: Cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of displaced intrauterine device after insertion in both groups
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jan 2019
- Primary completion1 Feb 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Device MigrationStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mahmoud Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780985
- Sponsor's protocol ID
- IUD-Zahraa
- Status last verified
- Sep 2021
- First submitted
- 18 Dec 2018
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hang-up Versus Non-fixation Technique for Immediate Post-placental Intrauterine Device Insertion During Cesarean Section
- ClinicalTrials.gov ID
- NCT03780985
- Acronym / sponsor ID
- IUD-Zahraa
- Conditions
- Intrauterine Device Migration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 19 Dec 2018 (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.
Effective, reversible postpartum contraception decreases the chance of rapid repeat pregnancy and poor perinatal outcome in a subsequent pregnancy especially in women delivered by cesarean section.The traditional 6-week postpartum visits not evidenced based and may not meet patient needs, particularly with respect to provision of contraception.Intrauterine device placement after delivery of the placenta is an appealing strategy for increasing access to postpartum Intrauterine device because it does not require a separate postpartum visit.
Advantage of post-placental Intrauterine device insertion, Intrauterine devices are recommended as first-line contraceptives by the American Academy of Pediatricians. The Centers for Disease Control and Prevention united state . Medical Eligibility Criteria for Contraceptive Use places no restrictions on use, and states advantages generally outweigh the risks for immediate postpartum use of Intrauterine devices.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrauterine device insertion with a suture fixation | Active comparator | Procedure: Intrauterine device insertion, Procedure: Cesarean section, Procedure: SutureIntruterine device through hysterotomy incision during cesarean section with a suture fixation |
| intrauterine device insertion without a suture fixation | Active comparator | Procedure: Intrauterine device insertion, Procedure: Cesarean sectionIUD through hysterotomy incision during cesarean section without a suture fixation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age group : 18-40 years
- Women who will be willing to undergo elective cesarean section
- women desire using Copper IUD as long acting contraceptive method.
Key exclusion criteria (6 listed)
- Intrauterine infection.
- Fundal Myoma.
- Hemorrhagic disorder
- Genital tract malignancy
- Uterine atony
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 |
|---|---|---|
| Intrauterine device insertionPost-placental insertion of intrauterine device during Cesarean section | Procedure or surgery | intrauterine device insertion with a suture fixation, intrauterine device insertion without a suture fixation |
| Cesarean sectionto delivery of the fetus | Procedure or surgery | intrauterine device insertion with a suture fixation, intrauterine device insertion without a suture fixation |
| Sutureto fix the intrauterine device | Procedure or surgery | intrauterine device insertion with a suture fixation |
Primary outcome
Number of displaced intrauterine device after insertion in both groups
Time frame: 2 weeks
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 16 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine device insertion, Cesarean section and Suture in people with Intrauterine Device Migration, run by Assiut 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 3 inclusion and 6 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 16 Sep 2021. 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?
Number of displaced intrauterine device after insertion in both groups (time frame: 2 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 16 Sep 2021.