IUD Insertion ComplicationNCT02522130
Different Analgesics Prior to Intrauterine Device (IUD) Insertion: Is There Any Evidence?
A study testing Lidocaine, oral misoprostol and naproxen in people with IUD Insertion Complication, run by Al Hayat National Hospital at 2 sites in 2 countries.
Trial summary
Different ways of reducing pain during IUD insertion have been explored. So a randomized study will be conducted to test their role Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD Insertion Complication
- What is being tested?
- Lidocaine, oral misoprostol and naproxen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2015to Dec 2016
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients are considered eligible if:
- they are alert oriented and co-operative to response to the visual analogue scale (VAS).
- They will sign the informed consent to participate in the clinical trial before entering the study.
- Willingness to be randomized and complete study questionnaires.
Who cannot join
- Participants are excluded from participation if they are ineligible for an IUD by accepted criteria of our institution such as:
- A lidocaine allergy
- Copper allergy
- Current cervicitis
- Pelvic inflammatory disease (PID) within 3 months
- Uterine anomalies
Show all 9Show fewer
- Pain medication within 6 hours before insertion
- Misoprostol administration within 24 hour before insertion
- History of cervical surgery and contraindication to study medications.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Egypt1 site, 1 recruiting
- Recruiting
Menoufia University
Shebin Elkom
nabih elkholy, MD, 00201060868443
Saudi Arabia1 site, 1 recruiting
- Recruiting
Alhayah national hospital
Abhā
mohamed maher, +966558198655
tarek sayyed
About this study
Official title: Different Analgesics Prior to IUD Insertion: Is There Any Evidence?
Different ways of reducing pain during IUD insertion have been explored. So a randomized study will be conducted to test their role
Read the detailed description
A randomized clinical controlled trial of women undergoing IUD insertion. Participants in the study groups will be randomly assigned by labeled opaque envelopes to either1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt), misoprostol (Sigma, Egypt), naproxen (Naprosyn, Syntax, Egypt) or placebo tablets.
- Conditions
- IUD Insertion Complication
- Being tested
- Lidocaine, oral misoprostol, naproxen, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
intracervical injection
oral misoprostolDrug
oral treatment
naproxenDrug
oral treatment
placeboOther
oral treatment
| Study group | Role | What they receive |
|---|---|---|
| lidocaine group | Active comparator | Group A will receive 10 ml 1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt) Para cervical block prior to insertion of IUD (injection sites at cervix-vaginal junction typically at 4 ,8 O'clock), Then 3 minutes waiting period between the administration of the Para cervical block and IUD insertion, Receives: Drug: Lidocaine |
| misoprostol group | Active comparator | Group B will receive 400 mcg oral misoprostol (Sigma, Egypt) prior to IUD insertion Receives: Drug: oral misoprostol |
| non steroid group | Active comparator | Group C will receive oral naproxen (Naprosyn, Syntax, Egypt) prior to IUD insertion Receives: Drug: naproxen |
| placebo group | Placebo comparator | group D will receive placebo tablets. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
current pain level with IUD insertion and 15 minutes post procedure measured by the Visual Analogue Scale.
A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range to across a continuum of values and can not easily to be directly measured. Subjects pain using a 10 point visual analogue scale (-+VAS, anchors: 0=non, 10 = worst imaginable).
The participants were asked to mark their pre IUD insertion pain expectancies initially, then to mark their pain during different steps of IUD placement.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUD Insertion 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayat National Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Principal investigator, mohamed maher, Al Hayat National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522130
- Sponsor's protocol ID
- ob/gyn4
- Status last verified
- Jun 2016
- First submitted
- 8 Jul 2015
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Analgesics Prior to IUD Insertion: Is There Any Evidence?
- ClinicalTrials.gov ID
- NCT02522130
- Acronym / sponsor ID
- ob/gyn4
- Conditions
- IUD Insertion Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Al Hayat National HospitalUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- 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.
Different ways of reducing pain during IUD insertion have been explored. So a randomized study will be conducted to test their role
Detailed description
A randomized clinical controlled trial of women undergoing IUD insertion. Participants in the study groups will be randomly assigned by labeled opaque envelopes to either1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt), misoprostol (Sigma, Egypt), naproxen (Naprosyn, Syntax, Egypt) or placebo tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lidocaine group | Active comparator | Drug: LidocaineGroup A will receive 10 ml 1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt) Para cervical block prior to insertion of IUD (injection sites at cervix-vaginal junction typically at 4 ,8 O'clock), Then 3 minutes waiting period between the administration of the Para cervical block and IUD insertion, |
| misoprostol group | Active comparator | Drug: oral misoprostolGroup B will receive 400 mcg oral misoprostol (Sigma, Egypt) prior to IUD insertion |
| non steroid group | Active comparator | Drug: naproxenGroup C will receive oral naproxen (Naprosyn, Syntax, Egypt) prior to IUD insertion |
| placebo group | Placebo comparator | Other: placebogroup D will receive placebo tablets. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- they are alert oriented and co-operative to response to the visual analogue scale (VAS).
- They will sign the informed consent to participate in the clinical trial before entering the study.
- Willingness to be randomized and complete study questionnaires.
Key exclusion criteria (9 listed)
- Participants are excluded from participation if they are ineligible for an IUD by accepted criteria of our institution such as:
- A lidocaine allergy
- Copper allergy
- Current cervicitis
- Pelvic inflammatory disease (PID) within 3 months
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 |
|---|---|---|
| Lidocaineintracervical injection | Drug | lidocaine group |
| oral misoprostoloral treatment | Drug | misoprostol group |
| naproxenoral treatment | Drug | non steroid group |
| placebooral treatment | Other | placebo group |
Primary outcome
current pain level with IUD insertion and 15 minutes post procedure measured by the Visual Analogue Scale.
Time frame: 15 minutes
A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range to across a continuum of values and can not easily to be directly measured. Subjects pain using a 10 point visual analogue scale (-+VAS, anchors: 0=non, 10 = worst imaginable). The participants were asked to mark their pre IUD insertion pain expectancies initially, then to mark their pain during different steps of IUD placement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine, oral misoprostol and naproxen in people with IUD Insertion Complication, run by Al Hayat National Hospital at 2 sites in 2 countries.
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 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: status not confirmed, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, Saudi Arabia. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
current pain level with IUD insertion and 15 minutes post procedure measured by the Visual Analogue Scale. (time frame: 15 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 22 Jun 2016.