Intrauterine Contraceptive Device ComplicationDODIUNCT07437235
A Comparative Study Evaluating Pain Experienced During Intrauterine Device Insertion in Women
An observational study of Intrauterine Contraceptive Device Complication, run by University Hospital, Rouen at 1 site in France.
Trial summary
The intrauterine device (IUD) is a reversible contraceptive method with good efficacy and long-lasting action. One of the obstacles to IUD insertion, both for healthcare professionals and patients, is the fear of painful insertion. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intrauterine Contraceptive Device Complication
- How many people
- 162 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2021to 30 Mar 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: nulliparous and multiparous women who accept the insertion of an intrauterine device
Who may be able to join
- Patients aged 18 or older
- Patients desiring intrauterine device (IUD) contraception.
- Patients without contraindications to the desired IUD contraception (uterine malformation, pregnancy, undiagnosed vaginal bleeding, current STI, Wilson's disease, uterine cancer, uterine fibroids, current phlebitis, breast cancer, hormone-sensitive condition, etc.).
- Patients agreeing to participate in the study.
- Patients agreeing to be contacted at 6 months and 1 year.
Who cannot join
- Patients under 18 years of age.
- Patients 25 years of age or younger who have not been screened for Chlamydia and Gonorrhea prior to IUD insertion.
- Patients with a contraindication to IUD insertion.
- Patients with risk factors for sexually transmitted infections.
- Patients with comprehension difficulties and/or a language barrier.
- Patients who object to participating in the study.
- Intrauterine device insertion by a practitioner in training (first insertion).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Regional, Multicenter Comparative Study Evaluating Pain Experienced During Intrauterine Device Insertion in Women According to Their Parity
The intrauterine device (IUD) is a reversible contraceptive method with good efficacy and long-lasting action.
One of the obstacles to IUD insertion, both for healthcare professionals and patients, is the fear of painful insertion.
There is little data in the literature on the pain experienced by patients, and even less in relation to their parity.
Several studies have been conducted and show that nulliparous women seemed to experience more intense pain compared to multiparous women (2.7 vs 1.9 p<0.05)
Read the detailed description
The hypotheses of this study are:
- Pain is more intense in nulliparous women than in multiparous women.
- Nulliparous women are more anxious before IUD insertion than multiparous women.
- Satisfaction rates at 6 and 12 months do not differ according to parity.
Pain will be assessed at each stage of IUD insertion using a numerical pain scale from 0 to 10 for speculum insertion, Pozzi forceps insertion, and IUD insertion, by the patient herself. Pain will be reassessed 5 minutes after insertion, also by the patient.
Patients' anxiety levels will be assessed before insertion using the Spielberger State Anxiety Scale. This is a self-administered questionnaire comprising 20 items. This is a 4-point Likert scale assessing the intensity of the subject's feelings ("no," "somewhat no," "somewhat yes," "yes").
The satisfaction rate will be assessed by telephone questionnaire at 6 and 12 months, allowing us to evaluate the continuation rate as well as potential side effects of this method of contraception, such as amenorrhea, spotting, headaches, or mastalgia.
Based on the results, the aim of this study is to propose appropriate pain management and information to reduce any anxiety and reassure patients about their satisfaction with this method of contraception.
- Keywords
- pain assessment, nulliparous/multiparous parity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nulliparous patients at the time of insertion of an intrauterine contraceptive system | The most appropriate care will be assessed in terms of pain management and information: pain will be evaluated at each stage of IUD insertion using a numerical pain scale from 0 to 10; the patient's anxiety level will be assessed before insertion using the Spielberger State Anxiety Scale; and the satisfaction rate will be evaluated via a telephone questionnaire at 6 and 12 months, allowing for the assessment of continuation rates as well as potential side effects. | |
| Multiparous patients at the time of insertion of an intrauterine contraceptive system | The most appropriate care will be assessed in terms of pain management and information: pain will be evaluated at each stage of IUD insertion using a numerical pain scale from 0 to 10; the patient's anxiety level will be assessed before insertion using the Spielberger State Anxiety Scale; and the satisfaction rate will be evaluated via a telephone questionnaire at 6 and 12 months, allowing for the assessment of continuation rates as well as potential side effects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of the study is to assess whether there is a significant difference between the pain experienced by nulliparous and multiparous women during the insertion of an intrauterine device.
The primary evaluation criterion is the pain experienced at each stage of IUD insertion. This will be assessed using a numerical pain scale from 0 to 10 during the insertion of the speculum, Pozzi forceps, and intrauterine device, by the patient immediately after insertion. Pain 5 minutes after insertion is also assessed using the same method.
Measured: Day 1
Secondary outcomes (5)
Evaluate the criteria motivating the choice of intrauterine device contraception in multiparous patients.
The criteria motivating the choice of IUD contraception will be assessed using a closed-ended question containing 10 items, with multiple possible answers.
Measured: 1 day
Evaluate the criteria motivating the choice of intrauterine device contraception in nulliparous patients.
The criteria motivating the choice of IUD contraception will be assessed using a closed-ended question containing 10 items, with multiple possible answers.
Measured: 1 day
Assessing the stress generated by the insertion of an intrauterine device
The patient's anxiety level will be assessed before the procedure using the Spielberger State Anxiety Scale. This self-administered questionnaire comprises 20 items. It uses a 4-point Likert scale to evaluate the intensity of the subject's feelings ("no," "somewhat no," "somewhat yes," "yes"). Each response to an item is scored from 1 to 4, with 1 indicating the lowest level of anxiety and 4 the highest. The score is calculated by summing the scores obtained for each item. The score can therefore range from 20 to 80.
Measured: 1 day
Evaluation of the rate of continued use at 6 months, then at 1 year during follow-up
The satisfaction rate will be assessed by a telephone questionnaire at 6 and 12 months, allowing for an evaluation of the continuation rate. This involves measuring the percentage of women who are still using the contraceptive system at 6 and 12 months.
Measured: 12 months
Evaluation of the side effects caused by this method of contraception during follow-up.
les potentiels effets secondaires engendrés par ce mode de contraception comme l'aménorrhée, la survenue de spotting, de céphalées, ou encore de mastodynie seront évalués par un questionnaire téléphonique à 6 mois et 12mois
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start23 Jun 2021
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Contraceptive Device 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle IM MOTTE, Doctor, Study director, Service de Gynécologie-Obstétrique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437235
- Sponsor's protocol ID
- 2021/091/OB
- Other IDs
- 2021-A010232-38
- Acronym
- DODIU
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Regional, Multicenter Comparative Study Evaluating Pain Experienced During Intrauterine Device Insertion in Women According to Their Parity
- ClinicalTrials.gov ID
- NCT07437235
- Acronym / sponsor ID
- DODIU / 2021/091/OB
- Keywords
- pain assessment, nulliparous/multiparous parity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 27 Feb 2026 (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.
The intrauterine device (IUD) is a reversible contraceptive method with good efficacy and long-lasting action.
One of the obstacles to IUD insertion, both for healthcare professionals and patients, is the fear of painful insertion.
There is little data in the literature on the pain experienced by patients, and even less in relation to their parity.
Several studies have been conducted and show that nulliparous women seemed to experience more intense pain compared to multiparous women (2.7 vs 1.9 p<0.05)
Detailed description
The hypotheses of this study are:
- Pain is more intense in nulliparous women than in multiparous women.
- Nulliparous women are more anxious before IUD insertion than multiparous women.
- Satisfaction rates at 6 and 12 months do not differ according to parity.
Pain will be assessed at each stage of IUD insertion using a numerical pain scale from 0 to 10 for speculum insertion, Pozzi forceps insertion, and IUD insertion, by the patient herself. Pain will be reassessed 5 minutes after insertion, also by the patient.
Patients' anxiety levels will be assessed before insertion using the Spielberger State Anxiety Scale. This is a self-administered questionnaire comprising 20 items. This is a 4-point Likert scale assessing the intensity of the subject's feelings ("no," "somewhat no," "somewhat yes," "yes").
The satisfaction rate will be assessed by telephone questionnaire at 6 and 12 months, allowing us to evaluate the continuation rate as well as potential side effects of this method of contraception, such as amenorrhea, spotting, headaches, or mastalgia.
Based on the results, the aim of this study is to propose appropriate pain management and information to reduce any anxiety and reassure patients about their satisfaction with this method of contraception.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nulliparous patients at the time of insertion of an intrauterine contraceptive system | – | –The most appropriate care will be assessed in terms of pain management and information: pain will be evaluated at each stage of IUD insertion using a numerical pain scale from 0 to 10; the patient's anxiety level will be assessed before insertion using the Spielberger State Anxiety Scale; and the satisfaction rate will be evaluated via a telephone questionnaire at 6 and 12 months, allowing for the assessment of continuation rates as well as potential side effects. |
| Multiparous patients at the time of insertion of an intrauterine contraceptive system | – | –The most appropriate care will be assessed in terms of pain management and information: pain will be evaluated at each stage of IUD insertion using a numerical pain scale from 0 to 10; the patient's anxiety level will be assessed before insertion using the Spielberger State Anxiety Scale; and the satisfaction rate will be evaluated via a telephone questionnaire at 6 and 12 months, allowing for the assessment of continuation rates as well as potential side effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- nulliparous and multiparous women who accept the insertion of an intrauterine device
Key inclusion criteria (5 listed)
- Patients aged 18 or older
- Patients desiring intrauterine device (IUD) contraception.
- Patients without contraindications to the desired IUD contraception (uterine malformation, pregnancy, undiagnosed vaginal bleeding, current STI, Wilson's disease, uterine cancer, uterine fibroids, current phlebitis, breast cancer, hormone-sensitive condition, etc.).
- Patients agreeing to participate in the study.
- Patients agreeing to be contacted at 6 months and 1 year.
Key exclusion criteria (7 listed)
- Patients under 18 years of age.
- Patients 25 years of age or younger who have not been screened for Chlamydia and Gonorrhea prior to IUD insertion.
- Patients with a contraindication to IUD insertion.
- Patients with risk factors for sexually transmitted infections.
- Patients with comprehension difficulties and/or a language barrier.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The main objective of the study is to assess whether there is a significant difference between the pain experienced by nulliparous and multiparous women during the insertion of an intrauterine device.
Time frame: Day 1
The primary evaluation criterion is the pain experienced at each stage of IUD insertion. This will be assessed using a numerical pain scale from 0 to 10 during the insertion of the speculum, Pozzi forceps, and intrauterine device, by the patient immediately after insertion. Pain 5 minutes after insertion is also assessed using the same method.
5 secondary outcomes
Evaluate the criteria motivating the choice of intrauterine device contraception in multiparous patients.
Time frame: 1 day
Evaluate the criteria motivating the choice of intrauterine device contraception in nulliparous patients.
Time frame: 1 day
Assessing the stress generated by the insertion of an intrauterine device
Time frame: 1 day
Evaluation of the rate of continued use at 6 months, then at 1 year during follow-up
Time frame: 12 months
Evaluation of the side effects caused by this method of contraception during follow-up.
Time frame: 12 months
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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.
Isabelle IM MOTTE, Doctor study director
Service de Gynécologie-Obstétrique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Contraceptive Device Complication, run by University Hospital, Rouen at 1 site in France.
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 5 inclusion and 7 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 27 Feb 2026. 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 France. 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?
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 main objective of the study is to assess whether there is a significant difference between the pain experienced by nulliparous and multiparous women during the insertion of an intrauterine device. (time frame: Day 1). 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 27 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.