IUDIUDinsertionNCT06023849
Trans Caesarean Intra Uterine Contraceptive Device Insertion Versus Conventional Postpartum 6 Weeks Insertion
A study testing IUD insertion in people with IUD, run by Al-Azhar University at 1 site in Egypt.
Trial summary
To compare immediate post-placental intrauterine contraceptive device insertion versus conventional placement at 6 weeks interval (often referred to as delayed or interval insertion) as regard to:- 1. Patient satisfaction. 2. Expulsion rate. 3. Complications 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
- IUD
- What is being tested?
- IUD insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to Sep 2024
- 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: 18-40years.
- Full term pregnancies delivered by cesarean section.
- Desire to have intrauterine contraceptive device (Cu T) as a contraceptive option.
- Agree to participate in the study.
Who cannot join
- Allergy to copper.
- Ante- or intra-partum hemorrhage.
- Ruptured of membranes for more than 18 h prior to delivery or Chorioamnionitis.
- Known uterine abnormalities e.g., Bicornuate/septate Uterus, uterine myoma.
- History of ectopic pregnancy.
- Desire for pregnancy within 1 year of delivery.
- Intrapartum fever >38 c.
- Sever thrombocytopenia.
Trial locations and contacts
1 site in 1 country.
Selim Ahmed, Assistant Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicin
Asyut
selim silem, professor, 01145883770
ahmed osman, MBBCH, 01068677095, AhmedOsman.2244@azhar.edu.eg
About this study
To compare immediate post-placental intrauterine contraceptive device insertion versus conventional placement at 6 weeks interval (often referred to as delayed or interval insertion) as regard to:-
- Patient satisfaction.
- Expulsion rate.
- Complications
Read the detailed description
Until the 1960s, Intrauterine devices (IUCDs) and condoms were the only artificial methods for the control of fertility. Nowadays ,despite the presence of 12 contraceptive methods which include 9 modern methods (pill, IUD, injectable, implant, vaginal methods (diaphragm and contraceptive foam or jelly), male condom, female sterilization, male sterilization, and emergency contraception) and 3 traditional methods (periodic abstinence, withdrawal, and prolonged breastfeeding , the insertion of an IUCD still the second most prevalent method of family planning used worldwide (13.6%), after female sterilization (20.5%), among women of reproductive age who are married or cohabiting.
In Egypt, Egypt Demographic and Health Survey 2014 findings revealed that 59 percent of currently married women in Egypt are currently using a contraceptive method. The most widely used method is the IUD, followed by the pill and injectables. Thirty percent of currently married women are using the IUD, 16 percent are relying on the pill, and 9 percent are employing injectables. Relatively small proportions of women are using other modern methods, e.g., 1 percent reported currently using female sterilization. Two percent of women report use of traditional methods.
There are two ways used in IUD insertion, in the postpartum period or immediate post-placental IUD insertion, in which the insertion of IUD occurs within ten minutes after placenta delivery and after the puerperium (after puerperal or interval period). Intrauterine device insertion during cesarean section was first introduced in 1967 by Zerzavy by suturing the IUD to the posterior uterine fundus. Research in China and Belgium introduced post-placental IUD insertion technique during cesarean delivery with placed an IUD as high as possible in the fundus without suturing the fundus wall.
Intrauterine device insertion during early postpartum period is the most effective reversible contraceptive methods for many mothers because the contraception motivation is high, and it doesn't interfere with breast feeding. On the other hand, without an effective contraception in the first six weeks, woman may be accidentally pregnant. Hence, the mother prefers to insert IUD during cesarean delivery.
As cesarean section (CS) rates are rising in all countries, IUD insertion at the time of CS creates an opportunity to increase access to long-acting reversible contraception methods. Conversely, a previous CS scar may deter access to interval insertion of an IUD if a previous CS may result in difficulty with insertion and/or future IUD problems.
Inserting an IUD at the time of CS is a very attractive option; It adds very little time and cost to the procedure. The patient does not have to come back especially for follow-up, and there is no risk of primary perforation (secondary perforation is possible) as it is performed under direct vision.
- Conditions
- IUD
- Being tested
- IUD insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUD insertionDevice
Trans Caesarean Intra Uterine Contraceptive Device Insertion and Conventional Postpartum 6 Weeks Insertion
| Study group | Role | What they receive |
|---|---|---|
| PPIUD | Active comparator | trans cesarean IUD insertion immediately post placental Receives: Device: IUD insertion |
| interval | Active comparator | IUD insertion 6 weeks interval post-partum Receives: Device: IUD insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Patient satisfaction and complication.
assessment of patient satisfaction using a questionnaire as follow:
- Will you use the same method of contraception after the next delivery?
- Will you recommend the same method to your fellows?
- Are you happy or not with this procedure? give score from 1 to 10, 1 mean you are very unhappy while 10 mean you are very happy.
- have you developed any complication?
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 posted5 Sep 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completionSep 2024 (estimated)
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 IUDStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M.Osman, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023849
- Sponsor's protocol ID
- Trans CS IUCD insertion
- Acronym
- IUDinsertion
- Status last verified
- Sep 2023
- First submitted
- 6 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hem E, Bordahl PE. Max Sanger - father of the modern caesarean section. Gynecol Obstet Invest. 2003;55(3):127-9. doi: 10.1159/000071524.
PubMed 12865589
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans Caesarean Intra Uterine Contraceptive Device Insertion Versus Conventional Postpartum 6 Weeks Insertion
- ClinicalTrials.gov ID
- NCT06023849
- Acronym / sponsor ID
- IUDinsertion / Trans CS IUCD insertion
- Conditions
- IUD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 5 Sep 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 compare immediate post-placental intrauterine contraceptive device insertion versus conventional placement at 6 weeks interval (often referred to as delayed or interval insertion) as regard to:-
- Patient satisfaction.
- Expulsion rate.
- Complications
Detailed description
Until the 1960s, Intrauterine devices (IUCDs) and condoms were the only artificial methods for the control of fertility. Nowadays ,despite the presence of 12 contraceptive methods which include 9 modern methods (pill, IUD, injectable, implant, vaginal methods (diaphragm and contraceptive foam or jelly), male condom, female sterilization, male sterilization, and emergency contraception) and 3 traditional methods (periodic abstinence, withdrawal, and prolonged breastfeeding , the insertion of an IUCD still the second most prevalent method of family planning used worldwide (13.6%), after female sterilization (20.5%), among women of reproductive age who are married or cohabiting.
In Egypt, Egypt Demographic and Health Survey 2014 findings revealed that 59 percent of currently married women in Egypt are currently using a contraceptive method. The most widely used method is the IUD, followed by the pill and injectables. Thirty percent of currently married women are using the IUD, 16 percent are relying on the pill, and 9 percent are employing injectables. Relatively small proportions of women are using other modern methods, e.g., 1 percent reported currently using female sterilization. Two percent of women report use of traditional methods.
There are two ways used in IUD insertion, in the postpartum period or immediate post-placental IUD insertion, in which the insertion of IUD occurs within ten minutes after placenta delivery and after the puerperium (after puerperal or interval period). Intrauterine device insertion during cesarean section was first introduced in 1967 by Zerzavy by suturing the IUD to the posterior uterine fundus. Research in China and Belgium introduced post-placental IUD insertion technique during cesarean delivery with placed an IUD as high as possible in the fundus without suturing the fundus wall.
Intrauterine device insertion during early postpartum period is the most effective reversible contraceptive methods for many mothers because the contraception motivation is high, and it doesn't interfere with breast feeding. On the other hand, without an effective contraception in the first six weeks, woman may be accidentally pregnant. Hence, the mother prefers to insert IUD during cesarean delivery.
As cesarean section (CS) rates are rising in all countries, IUD insertion at the time of CS creates an opportunity to increase access to long-acting reversible contraception methods. Conversely, a previous CS scar may deter access to interval insertion of an IUD if a previous CS may result in difficulty with insertion and/or future IUD problems.
Inserting an IUD at the time of CS is a very attractive option; It adds very little time and cost to the procedure. The patient does not have to come back especially for follow-up, and there is no risk of primary perforation (secondary perforation is possible) as it is performed under direct vision.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPIUD | Active comparator | Device: IUD insertiontrans cesarean IUD insertion immediately post placental |
| interval | Active comparator | Device: IUD insertionIUD insertion 6 weeks interval post-partum |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-40years.
- Full term pregnancies delivered by cesarean section.
- Desire to have intrauterine contraceptive device (Cu T) as a contraceptive option.
- Agree to participate in the study.
Key exclusion criteria (8 listed)
- Allergy to copper.
- Ante- or intra-partum hemorrhage.
- Ruptured of membranes for more than 18 h prior to delivery or Chorioamnionitis.
- Known uterine abnormalities e.g., Bicornuate/septate Uterus, uterine myoma.
- History of ectopic pregnancy.
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 |
|---|---|---|
| IUD insertionTrans Caesarean Intra Uterine Contraceptive Device Insertion and Conventional Postpartum 6 Weeks Insertion | Device | PPIUD, interval |
Primary outcome
1-Patient satisfaction and complication.
Time frame: 6 months
assessment of patient satisfaction using a questionnaire as follow: * Will you use the same method of contraception after the next delivery? * Will you recommend the same method to your fellows? * Are you happy or not with this procedure? give score from 1 to 10, 1 mean you are very unhappy while 10 mean you are very happy. * have you developed any complication?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Background: PubMed 12865589Hem E, Bordahl PE. Max Sanger - father of the modern caesarean section. Gynecol Obstet Invest. 2003;55(3):127-9. doi: 10.1159/000071524.
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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.
Selim Ahmed, Assistant Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUD insertion in people with IUD, run by Al-Azhar 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 4 inclusion and 8 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 5 Sep 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 Ahmed osman, M.B.B.Ch (01145883770, AhmedOsman.2244@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Patient satisfaction and complication. (time frame: 6 months). 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 NCT06023849, 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 5 Sep 2023.