Intrauterine DevicePhase 4NCT04045548
Vaginal Dinoprostone Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System in Women With no Previous Vaginal Delivery
A Phase 4 study testing Dinoprostone in people with Intrauterine Device, run by Cairo University at 1 site in Egypt.
Trial summary
To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Intrauterine Device
- What is being tested?
- Dinoprostone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2019to 5 Jan 2020
- Phase
- Phase 4
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Non-pregnant women
- Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
- Women who delivered only by cesarean section
Who cannot join
- Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
- Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
- Allergy to dinoprostone.
- Women refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of Vaginal Dinoprostone Administration Prior to Levonorgestrel-releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double-blind Clinical Trial.
To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.
Read the detailed description
Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.
- Conditions
- Intrauterine Device
- Being tested
- Dinoprostone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DinoprostoneDrug
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.
PlaceboDrug
one tablet of placebo inserted by the study nurse 6 hours before IUD insertion.
| Study group | Role | What they receive |
|---|---|---|
| dinoprostone | Experimental | 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 2 hours before IUD insertion. Receives: Drug: Dinoprostone |
| placebo | Placebo comparator | one tablet of placebo inserted by the study nurse 2 hours before IUD insertion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in pain scores during intrauterine device insertion
The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start10 Aug 2019
- Primary completion1 Jan 2020
- Study completion5 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine DeviceStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045548
- Sponsor's protocol ID
- dinoprostone IUD
- Status last verified
- Jan 2020
- First submitted
- 2 Aug 2019
- Last updated
- 13 Jan 2020
- 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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Vaginal Dinoprostone Administration Prior to Levonorgestrel-releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT04045548
- Acronym / sponsor ID
- dinoprostone IUD
- Conditions
- Intrauterine Device
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 5 Jan 2020 (actual)
- First posted
- 5 Aug 2019 (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 investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.
Detailed description
Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dinoprostone | Experimental | Drug: Dinoprostone1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 2 hours before IUD insertion. |
| placebo | Placebo comparator | Drug: Placeboone tablet of placebo inserted by the study nurse 2 hours before IUD insertion. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-pregnant women
- Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
- Women who delivered only by cesarean section
Key exclusion criteria (4 listed)
- Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
- Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
- Allergy to dinoprostone.
- Women refuse to participate in the study
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 |
|---|---|---|
| Dinoprostone1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion. | Drug | dinoprostone |
| Placeboone tablet of placebo inserted by the study nurse 6 hours before IUD insertion. | Drug | placebo |
Primary outcome
The difference in pain scores during intrauterine device insertion
Time frame: 10 minutes
The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10
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 13 Jan 2020.
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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.
AHMED SAMY 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 Phase 4 study testing Dinoprostone in people with Intrauterine Device, run by Cairo 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 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 13 Jan 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The difference in pain scores during intrauterine device insertion (time frame: 10 minutes). 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 13 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.