IUCD ComplicationNCT04505943
Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion
A study testing Isonicotinic Acid Hydrazide, dinoprostine and misoprostol in people with IUCD Complication, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
To compare the effect of vaginal dinoprostone versus vaginal misoprostol and Isonicotinic Acid Hydrazide administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- IUCD Complication
- What is being tested?
- Isonicotinic Acid Hydrazide, dinoprostine and misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Sep 2021
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- nulliparous women requesting copper IUD insertion
Who cannot join
- pregnancy,
- Parous women,
- contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion,
- untreated active cervicitis or vaginitis,
- undiagnosed abnormal uterine bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion in Nulliparous Women : a Randomized Controlled Study
To compare the effect of vaginal dinoprostone versus vaginal misoprostol and Isonicotinic Acid Hydrazide administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous women.
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
- IUCD Complication
- Being tested
- Isonicotinic Acid Hydrazide, dinoprostine, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isonicotinic Acid HydrazideDrug
Also called INH
2 vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.
dinoprostineDrug
Also called prostin
2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.
misoprostolDrug
Also called Misotac
2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion
| Study group | Role | What they receive |
|---|---|---|
| isonicotinic acid hydrazide | Experimental | 2vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion. Receives: Drug: Isonicotinic Acid Hydrazide |
| dinoprostone | Active comparator | 2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 12 hours before IUD insertion. Receives: Drug: dinoprostine |
| misoprostol | Active comparator | 2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 12hours before IUD insertion. Receives: Drug: misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in visual analog scale 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 minuts
Secondary outcomes (3)
the difference in visual analog scale pain scores during tenaculum application
The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10
Measured: 10 minuts
the ease of IUD insertion
the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion)
Measured: 10 minutes
women's satisfaction level: score
women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction
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 posted10 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUCD ComplicationStudies 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
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- nahla w Shady, md, Study chair, Aswan universirty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505943
- Sponsor's protocol ID
- aswu/352/5/19
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion in Nulliparous Women : a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04505943
- Acronym / sponsor ID
- aswu/352/5/19
- Conditions
- IUCD Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 10 Aug 2020 (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 the effect of vaginal dinoprostone versus vaginal misoprostol and Isonicotinic Acid Hydrazide administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous women.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| isonicotinic acid hydrazide | Experimental | Drug: Isonicotinic Acid Hydrazide2vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion. |
| dinoprostone | Active comparator | Drug: dinoprostine2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 12 hours before IUD insertion. |
| misoprostol | Active comparator | Drug: misoprostol2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 12hours before IUD insertion. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- nulliparous women requesting copper IUD insertion
Key exclusion criteria (5 listed)
- pregnancy,
- Parous women,
- contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion,
- untreated active cervicitis or vaginitis,
- undiagnosed abnormal uterine bleeding
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 |
|---|---|---|
| Isonicotinic Acid HydrazideAlso: INH2 vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion. | Drug | isonicotinic acid hydrazide |
| dinoprostineAlso: prostin2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion. | Drug | dinoprostone |
| misoprostolAlso: Misotac2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion | Drug | misoprostol |
Primary outcome
The difference in visual analog scale pain scores during intrauterine device insertion
Time frame: 10 minuts
The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10
3 secondary outcomes
the difference in visual analog scale pain scores during tenaculum application
Time frame: 10 minuts
the ease of IUD insertion
Time frame: 10 minutes
women's satisfaction level: score
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for IUCD Complication
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Tirzepatide and Levonorgestrel IUD Therapy for EIN and Early-Stage Endometrial Cancer
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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.
nahla w Shady, md study chair
Aswan universirty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isonicotinic Acid Hydrazide, dinoprostine and misoprostol in people with IUCD Complication, run by Aswan University Hospital 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 5 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 18 Aug 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. 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 hany f Sallam, md (+20102435461 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in visual analog scale pain scores during intrauterine device insertion (time frame: 10 minuts). 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 18 Aug 2020.