IUD InsertionPhase 4NCT04046302
Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.
A Phase 4 study testing Dinoprostone in people with IUD Insertion, run by Cairo University at 1 site in Egypt.
Trial summary
To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- IUD Insertion
- 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
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2019to 30 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test.
Who cannot join
- currently pregnant or were pregnant within 6 weeks of study entry
- had a prior attempted or successful IUD insertion
- had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy
- any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD
- active vaginitis or cervicitis
- undiagnosed abnormal uterine bleeding
Show all 9Show fewer
- pelvic inflammatory disease within the last 3 months
- fibroids or other uterine abnormalities distorting the uterine cavity
- contraindication or allergy to dinoprostone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Self-Administered Vaginal Dinoprostone on Pain Perception During Copper Intrauterine Device Insertion in Parous Women: a Randomized Controlled Trial
To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.
Read the detailed description
Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally. Pain can be perceived during all steps of IUD insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through the cervical canal inside the uterine cavity
- Conditions
- IUD Insertion
- 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) self-inserted by participants 3 hours before scheduled IUD insertion appointment.
placeboDrug
one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.
| Study group | Role | What they receive |
|---|---|---|
| dinoprostone | Experimental | 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by the patients 3 hours before the scheduled IUD insertion appointment. Receives: Drug: Dinoprostone |
| placebo | Placebo comparator | one tablet of placebo self-inserted by the patients 3 hours before the scheduled IUD insertion appointment. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in the pain intensity scores between the study groups
the difference in the pain intensity scores between the study groups by visual analog scale score which ranges from zero to 10.where zero represents no pain and 10 represents the most worst pain
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start30 Aug 2019
- Primary completion10 Jan 2020
- Study completion30 Jan 2020
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 IUD InsertionStudies 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
- 160 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
- NCT04046302
- Sponsor's protocol ID
- dinoprostone IUD pain
- Status last verified
- Mar 2020
- First submitted
- 4 Aug 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ashour AS, Nabil H, Yosif MF, Hussein M, Mageed A Allah AA, Mahmoud M, Abdou H, Kholaif K, Mohamed Kotb MM, El Sharkawy M, Abdelhakim AM, Ali AS, Nassar SA, Abbassy AH, Ghamry NK, Abdel-Latif AA, Taher A, El Mahy M. Effect of self-administered vaginal dinoprostone on pain perception during copper intrauterine device insertion in parous women: a randomized controlled trial. Fertil Steril. 2020 Oct;114(4):861-868. doi: 10.1016/j.fertnstert.2020.05.004. Epub 2020 Jul 28.
PubMed 32732105
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-Administered Vaginal Dinoprostone on Pain Perception During Copper Intrauterine Device Insertion in Parous Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04046302
- Acronym / sponsor ID
- dinoprostone IUD pain
- Conditions
- IUD Insertion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 6 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 intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.
Detailed description
Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally. Pain can be perceived during all steps of IUD insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through the cervical canal inside the uterine cavity
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) self-inserted by the patients 3 hours before the scheduled IUD insertion appointment. |
| placebo | Placebo comparator | Drug: placeboone tablet of placebo self-inserted by the patients 3 hours before the scheduled IUD insertion appointment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test.
Key exclusion criteria (9 listed)
- currently pregnant or were pregnant within 6 weeks of study entry
- had a prior attempted or successful IUD insertion
- had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy
- any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD
- active vaginitis or cervicitis
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) self-inserted by participants 3 hours before scheduled IUD insertion appointment. | Drug | dinoprostone |
| placeboone tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment. | Drug | placebo |
Primary outcome
the difference in the pain intensity scores between the study groups
Time frame: 5 minutes
the difference in the pain intensity scores between the study groups by visual analog scale score which ranges from zero to 10.where zero represents no pain and 10 represents the most worst pain
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 10 Mar 2020.
- Derived from this study: PubMed 32732105Ashour AS, Nabil H, Yosif MF, Hussein M, Mageed A Allah AA, Mahmoud M, Abdou H, Kholaif K, Mohamed Kotb MM, El Sharkawy M, Abdelhakim AM, Ali AS, Nassar SA, Abbassy AH, Ghamry NK, Abdel-Latif AA, Taher A, El Mahy M. Effect of self-administered vaginal dinoprostone on pain perception during copper intrauterine device insertion in parous women: a randomized controlled trial. Fertil Steril. 2020 Oct;114(4):861-868. doi: 10.1016/j.fertnstert.2020.05.004. Epub 2020 Jul 28.
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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 IUD Insertion, 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 1 inclusion and 9 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 10 Mar 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 the pain intensity scores between the study groups (time frame: 5 minutes). 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 NCT04046302, 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 10 Mar 2020.