IUCD ComplicationPhase 4NCT04499989
Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion
A Phase 4 study testing INH in people with IUCD Complication, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in in Women Delivered Only by Cesarean Delivery. 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?
- INH
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 Aug 2021
- 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 45 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 isonicotinic acid hydrazide .
- Women refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery: a Randomized Double Blinded Clinical Trial
To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in in Women Delivered Only by Cesarean Delivery.
Read the detailed description
Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device is attempted through a narrow cervical canal. intrauterine device insertion- related complications and side effects are more common among women who had never delivered vaginally.
- Conditions
- IUCD Complication
- Being tested
- INH, Placebo Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INHDrug
Also called isonicotinic acid hydrazide
3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.
Placebo ComparatorDrug
3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion
| Study group | Role | What they receive |
|---|---|---|
| INH | Experimental | 3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion. Receives: Drug: INH |
| Placebo Comparator | Placebo comparator | 3 vaginal tablet of Placebo Comparator self-inserted by the patient 12 hours before IUD insertion. Receives: Drug: Placebo Comparator |
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 at IUD insertion BY10 cm visual analog scale score where 0 denotes no pain and 10 denotes the most imaginable pain
Measured: 10 minutes
Secondary outcomes (2)
Provider ease of insertion
Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.
Measured: 10 minutes
insertion time
IUD insertion time from speculum in to speculum out
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 2020
- Study start1 Sep 2020
- Primary completion30 Jun 2021
- Study completion1 Aug 2021
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind randomized trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
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
- NCT04499989
- Sponsor's protocol ID
- aswu/353/4/19
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2020
- Last updated
- 9 Aug 2021
- 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 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery: a Randomized Double Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT04499989
- Acronym / sponsor ID
- aswu/353/4/19
- Conditions
- IUCD Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 5 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 investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in in Women Delivered Only by Cesarean Delivery.
Detailed description
Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device is attempted through a narrow cervical canal. intrauterine device insertion- related complications and side effects are more common among women who had never delivered vaginally.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind randomized trial
| Arm | Type | Receives |
|---|---|---|
| INH | Experimental | Drug: INH3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion. |
| Placebo Comparator | Placebo comparator | Drug: Placebo Comparator3 vaginal tablet of Placebo Comparator self-inserted by the patient 12 hours before IUD insertion. |
Who may qualify
- Ages
- 18 to 45 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 isonicotinic acid hydrazide .
- 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 |
|---|---|---|
| INHAlso: isonicotinic acid hydrazide3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion. | Drug | INH |
| Placebo Comparator3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion | Drug | Placebo Comparator |
Primary outcome
the difference in the pain intensity scores between the study groups
Time frame: 10 minutes
the difference in the pain intensity scores between the study groups at IUD insertion BY10 cm visual analog scale score where 0 denotes no pain and 10 denotes the most imaginable pain
2 secondary outcomes
Provider ease of insertion
Time frame: 10 minutes
insertion time
Time frame: 10 minutes
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 9 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for IUCD Complication
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A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
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Active, not recruitingPhase 2
Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer
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Not yet recruitingEarly Phase 1
Tirzepatide and Levonorgestrel IUD Therapy for EIN and Early-Stage Endometrial Cancer
Grade 1 Endometrial Endometrioid Carcinoma, Endometrial Intraepithelial Neoplasia
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 Phase 4 study testing INH 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 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 9 Aug 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. 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: 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 9 Aug 2021.