Induced AbortionNCT05532085
Assessment of Pain During an Abortion With Knowledge of the Predictive Factors of Pain.
An observational study of Induced Abortion and Medical Abortion, run by Olivier CHASSANY at 1 site in France.
Trial summary
Two studies carried out in 2011 at the Center for Contraception and Voluntary Interruption of Pregnancy (CIVG) at the Louis-Mourier Hospital, evaluated the pain of patients undergoing an abortion, and looked for predictors of the pain felt during an abortion. medication or aspiration under local anesthesia. Read more about this study
- Who is it for?
- Ages 15 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Abortion, Medical Abortion, Surgical Abortion
- What is being tested?
- Evaluation of pain during voluntary termination of pregnancy with medication following consideration of predictive factors of pain without an established analgesic protocol, Evaluation of pain during a voluntary medical termination of pregnancy following consideration of predictive factors of pain with an established analgesic protocol and Assessment of pain during voluntary termination of pregnancy by aspiration under local anesthesia following consideration of predictive factors of pain without an established analgesic protocol
- Type of treatment
- Pill or oral medicine
- How many people
- 362 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2020to 31 Dec 2021
- 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 15 to 70 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All women over the age of 15, benefiting from a medical abortion or by aspiration under local anesthesia.
Who may be able to join
- The population studied will concern all women over the age of 15 wishing to benefit from a medical abortion or by aspiration under local anesthesia.
- Understanding French orally, speaking it.
- Agreeing to participate in the study.
Who cannot join
- Unable to obtain information
- Not fluent in French
- Presenting complications (retention, clots) on the day of the abortion or after it.
- Aged under 15
- Refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Interruption Volontaire de Grossesse et de Contraception de l'Hôpital Louis Mourier
Colombes, 92700
About this study
Official title: Assessment of Pain During Voluntary Termination of Pregnancy Following Consideration of Predictive Factors of Pain, With and Without an Established Analgesic Protocol.
Two studies carried out in 2011 at the Center for Contraception and Voluntary Interruption of Pregnancy (CIVG) at the Louis-Mourier Hospital, evaluated the pain of patients undergoing an abortion, and looked for predictors of the pain felt during an abortion. medication or aspiration under local anesthesia.
These predictive factors of pain are today integrated into the interview during a request for abortion at the CIVG of Louis-Mourier.
Read more
This new study, on care data, prospective and monocentric conducted at the CIVG, of the Louis Mourier hospital, will make it possible to verify whether the knowledge of these predictive factors of pain has made it possible to improve the management of pain in women undergoing an abortion.
The main objective is to assess the pain felt by the patient during a medical abortion or by aspiration under local anesthesia, knowing the predictive factors of pain highlighted by two studies carried out in 2011.
The secondary objective is to highlight a significant difference in pain after application of an analgesic protocol indexed on predictive factors of pain.
The study will be carried out in two successive periods:
A first period of 4 months will consist in evaluating the pain felt by women having a medical abortion or by aspiration under local anesthesia.
A second period of 4 months will evaluate the pain felt by women undergoing medical or aspiration abortion under local anesthesia following the application of an analgesic protocol indexed on the predictive factors of pain.
The expected benefit of this study is the improvement of care and professional practices for better management of pain during outpatient abortion.
The abortion will take place in the usual way according to the chosen method. An information and non-objection note will be distributed to patients during the first consultation for an abortion.
Patients agreeing to participate in the study will answer the usual questions from the doctor or nurse.
A data collection sheet related to care will be integrated into the medical records. The CIVG doctors taking part in the study will report the data collected on this form.
The maximum pain felt during the abortion and in the following 4 days will be evaluated using an VAS according to usual practice.
Read the detailed description
Procedure in two successive periods (Phase 1 and Phase 2) of 4 months each:
Phase 1: Evaluation of the pain felt by women undergoing medical or aspiration abortion under local anesthesia at the CIVG in Louis-Mourier.
Phase 2: Evaluation of the pain felt by women having a medical abortion or by aspiration under local anesthesia following the application of an analgesic protocol indexed on the predictive factors of pain at the CIVG of Louis-Mourier.
The progress of each of the phases is identical, only the management of the pain will be different.
During Phase 1, the analgesic choice will be left to the discretion of the doctor, as is already done at the CIVG of Louis Mourier.
During phase 2, analgesic management will be directed according to the presence of predictive factors of pain. The usual analgesics were integrated into an analgesic protocol indexed on the presence of predictive factors of pain.
- Conditions
- Induced Abortion, Medical Abortion, Surgical Abortion, Pain
- Being tested
- Evaluation of pain during voluntary termination of pregnancy with medication following consideration of predictive factors of pain without an established analgesic protocol, Evaluation of pain during a voluntary medical termination of pregnancy following consideration of predictive factors of pain with an established analgesic protocol, Assessment of pain during voluntary termination of pregnancy by aspiration under local anesthesia following consideration of predictive factors of pain without an established analgesic protocol, Assessment of pain during voluntary termination of pregnancy by aspiration under local anesthesia following consideration of predictive factors of pain with established analgesic protocol
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of pain during voluntary termination of pregnancy with medication following consideration of predictive factors of pain without an established analgesic protocolOther
Evaluation of the pain felt by women having an abortion by aspiration under local anes!thesia.
The intensity of the pain of patients during an abortion by aspiration under local anesthesia will be quantified by a Visual Analogue Scale (VAS) at the time of the abortion and in the following 4 days.
Evaluation of pain during a voluntary medical termination of pregnancy following consideration of predictive factors of pain with an established analgesic protocolOther
Evaluation of the pain felt by women having a medical abortion following the application of an analgesic protocol indexed on the predictive factors of pain.
The intensity of the pain of patients during a medical abortion will be quantified by a Visual Analogue Scale (VAS) at the time of the abortion and in the following 4 days.
Assessment of pain during voluntary termination of pregnancy by aspiration under local anesthesia following consideration of predictive factors of pain without an established analgesic protocolOther
Evaluation of the pain felt by women having an abortion by aspiration under local anesthesia.
The intensity of the pain of patients during an abortion by aspiration under local anesthesia will be quantified by a Visual Analogue Scale (VAS) at the time of the abortion and in the following 4 days.Evaluation of the pain felt by women having an abortion by aspiration under local anesthesia.
The intensity of the pain of patients during an abortion by aspiration under local anesthesia will be quantified by a Visual Analogue Scale (VAS) at the time of the abortion and in the following 4 days.
Assessment of pain during voluntary termination of pregnancy by aspiration under local anesthesia following consideration of predictive factors of pain with established analgesic protocolOther
Evaluation of the pain felt by women having an abortion by aspiration under local anesthesia following the application of an analgesic protocol indexed on the predictive factors of pain.
The intensity of the pain of patients during an abortion by aspiration under local anesthesia will be quantified by a Visual Analogue Scale (VAS) at the time of the abortion and in the following 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Group: Medical abortion without analgesic protocol | All women over the age of 15, benefiting from a medical abortion between June and October 2020, including oral French. Receives: Other: Evaluation of pain during voluntary termination of pregnancy with medication following consideration of predictive factors of pain without an established analgesic protocol | |
| Group: Medical abortion with analgesic protocol | All women over the age of 15, benefiting from a medical abortion between October 2020 and February 2021, including spoken French. Receives: Other: Evaluation of pain during a voluntary medical termination of pregnancy following consideration of predictive factors of pain with an established analgesic protocol | |
| Group: Abortion by aspiration under local anesthesia without analgesic protocol | All women over the age of 15, benefiting from an abortion by aspiration under local anesthesia between June and October 2020, including oral French. Receives: Other: Assessment of pain during voluntary termination of pregnancy by aspiration under local anesthesia following consideration of predictive factors of pain without an established analgesic protocol | |
| Group: Abortion by aspiration under local anesthesia with analgesic protocol | All women over the age of 15, benefiting from an abortion by aspiration under local anesthesia between October 2020 and February 2021, including oral French. Receives: Other: Assessment of pain during voluntary termination of pregnancy by aspiration under local anesthesia following consideration of predictive factors of pain with established analgesic protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the pain felt by the patient during a medical abortion or by aspiration under LA, knowing the predictive factors of pain highlighted by two studies carried out in 2011.
Pain VAS 0-100 mm (100 = worst pain)
Measured: From the abortion to the follow-up visit two to four weeks after the abortion
Secondary outcomes (1)
Highlight a significant difference in pain after application of an analgesic protocol indexed on predictive factors of pain.
Pain VAS 0-100 mm (100 = worst pain)
Measured: From the abortion to the follow-up visit two to four weeks after the abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start12 Jun 2020
- Primary completion31 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced AbortionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olivier CHASSANY
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olivier CHASSANY, University Paris 7 - Denis Diderot
- Investigators
- Catherine Soulat, docteur, Study director, CIVG hôpital Louis Mourier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532085
- Sponsor's protocol ID
- ED-IVG
- Status last verified
- Sep 2022
- First submitted
- 27 May 2022
- Last updated
- 13 Sep 2022
- 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 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pain During Voluntary Termination of Pregnancy Following Consideration of Predictive Factors of Pain, With and Without an Established Analgesic Protocol.
- ClinicalTrials.gov ID
- NCT05532085
- Acronym / sponsor ID
- ED-IVG
- Conditions
- Induced Abortion, Medical Abortion, Surgical Abortion, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Olivier CHASSANYUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Sep 2022 (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.
Two studies carried out in 2011 at the Center for Contraception and Voluntary Interruption of Pregnancy (CIVG) at the Louis-Mourier Hospital, evaluated the pain of patients undergoing an abortion, and looked for predictors of the pain felt during an abortion. medication or aspiration under local anesthesia.
These predictive factors of pain are today integrated into the interview during a request for abortion at the CIVG of Louis-Mourier.
This new study, on care data, prospective and monocentric conducted at the CIVG, of the Louis Mourier hospital, will make it possible to verify whether the knowledge of these predictive factors of pain has made it possible to improve the management of pain in women undergoing an abortion.
The main objective is to assess the pain felt by the patient during a medical abortion or by aspiration under local anesthesia, knowing the predictive factors of pain highlighted by two studies carried out in 2011.
The secondary objective is to highlight a significant difference in pain after application of an analgesic protocol indexed on predictive factors of pain.
The study will be carried out in two successive periods:
A first period of 4 months will consist in evaluating the pain felt by women having a medical abortion or by aspiration under local anesthesia.
A second period of 4 months will evaluate the pain felt by women undergoing medical or aspiration abortion under local anesthesia following the application of an analgesic protocol indexed on the predictive factors of pain.
The expected benefit of this study is the improvement of care and professional practices for better management of pain during outpatient abortion.
The abortion will take place in the usual way according to the chosen method. An information and non-objection note will be distributed to patients during the first consultation for an abortion.
Patients agreeing to participate in the study will answer the usual questions from the doctor or nurse.
A data collection sheet related to care will be integrated into the medical records. The CIVG doctors taking part in the study will report the data collected on this form.
The maximum pain felt during the abortion and in the following 4 days will be evaluated using an VAS according to usual practice.
Detailed description
Procedure in two successive periods (Phase 1 and Phase 2) of 4 months each:
Phase 1: Evaluation of the pain felt by women undergoing medical or aspiration abortion under local anesthesia at the CIVG in Louis-Mourier.
Phase 2: Evaluation of the pain felt by women having a medical abortion or by aspiration under local anesthesia following the application of an analgesic protocol indexed on the predictive factors of pain at the CIVG of Louis-Mourier.
The progress of each of the phases is identical, only the management of the pain will be different.
During Phase 1, the analgesic choice will be left to the discretion of the doctor, as is already done at the CIVG of Louis Mourier.
During phase 2, analgesic management will be directed according to the presence of predictive factors of pain. The usual analgesics were integrated into an analgesic protocol indexed on the presence of predictive factors of pain.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group: Medical abortion without analgesic protocol | – | Other: Evaluation of pain during voluntary termination of pregnancy with medication following consideration of predictive factors of pain without an established analgesic protocolAll women over the age of 15, benefiting from a medical abortion between June and October 2020, including oral French. |
| Group: Medical abortion with analgesic protocol | – | Other: Evaluation of pain during a voluntary medical termination of pregnancy following consideration of predictive factors of pain with an established analgesic protocolAll women over the age of 15, benefiting from a medical abortion between October 2020 and February 2021, including spoken French. |
| Group: Abortion by aspiration under local anesthesia without analgesic protocol | – | Other: Assessment of pain during voluntary termination of pregnancy by aspiration under local anesthesia following consideration of predictive factors of pain without an established analgesic protocolAll women over the age of 15, benefiting from an abortion by aspiration under local anesthesia between June and October 2020, including oral French. |
| Group: Abortion by aspiration under local anesthesia with analgesic protocol | – | Other: Assessment of pain during voluntary termination of pregnancy by aspiration under local anesthesia following consideration of predictive factors of pain with established analgesic protocolAll women over the age of 15, benefiting from an abortion by aspiration under local anesthesia between October 2020 and February 2021, including oral French. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women over the age of 15, benefiting from a medical abortion or by aspiration under local anesthesia.
Key inclusion criteria (3 listed)
- The population studied will concern all women over the age of 15 wishing to benefit from a medical abortion or by aspiration under local anesthesia.
- Understanding French orally, speaking it.
- Agreeing to participate in the study.
Key exclusion criteria (5 listed)
- Unable to obtain information
- Not fluent in French
- Presenting complications (retention, clots) on the day of the abortion or after it.
- Aged under 15
- Refusing 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 |
|---|---|---|
| Evaluation of pain during voluntary termination of pregnancy with medication following consideration of predictive factors of pain without an established analgesic protocolEvaluation of the pain felt by women having an abortion by aspiration under local anes!thesia. The intensity of the pain of patients during an abortion by aspiration under local anesthesia will be quantified by a Visual Analogue Scale (VAS) at the time of the abortion and in the following 4 days. | Other | Group: Medical abortion without analgesic protocol |
| Evaluation of pain during a voluntary medical termination of pregnancy following consideration of predictive factors of pain with an established analgesic protocolEvaluation of the pain felt by women having a medical abortion following the application of an analgesic protocol indexed on the predictive factors of pain. The intensity of the pain of patients during a medical abortion will be quantified by a Visual Analogue Scale (VAS) at the time of the abortion and in the following 4 days. | Other | Group: Medical abortion with analgesic protocol |
| Assessment of pain during voluntary termination of pregnancy by aspiration under local anesthesia following consideration of predictive factors of pain without an established analgesic protocolEvaluation of the pain felt by women having an abortion by aspiration under local anesthesia. The intensity of the pain of patients during an abortion by aspiration under local anesthesia will be quantified by a Visual Analogue Scale (VAS) at the time of the abortion and in the following 4 days.Evaluation of the pain felt by women having an abortion by aspiration under local anesthesia. The intensity of the pain of patients during an abortion by aspiration under local anesthesia will be quantified by a Visual Analogue Scale (VAS) at the time of the abortion and in the following 4 days. | Other | Group: Abortion by aspiration under local anesthesia without analgesic protocol |
| Assessment of pain during voluntary termination of pregnancy by aspiration under local anesthesia following consideration of predictive factors of pain with established analgesic protocolEvaluation of the pain felt by women having an abortion by aspiration under local anesthesia following the application of an analgesic protocol indexed on the predictive factors of pain. The intensity of the pain of patients during an abortion by aspiration under local anesthesia will be quantified by a Visual Analogue Scale (VAS) at the time of the abortion and in the following 4 days. | Other | Group: Abortion by aspiration under local anesthesia with analgesic protocol |
Primary outcome
Evaluate the pain felt by the patient during a medical abortion or by aspiration under LA, knowing the predictive factors of pain highlighted by two studies carried out in 2011.
Time frame: From the abortion to the follow-up visit two to four weeks after the abortion
Pain VAS 0-100 mm (100 = worst pain)
1 secondary outcome
Highlight a significant difference in pain after application of an analgesic protocol indexed on predictive factors of pain.
Time frame: From the abortion to the follow-up visit two to four weeks after the abortion
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 13 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Catherine Soulat, docteur study director
CIVG hôpital Louis Mourier
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 Induced Abortion and Medical Abortion, run by Olivier CHASSANY 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 3 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: finished, as of the sponsor's last update on 13 Sep 2022. 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?
Evaluate the pain felt by the patient during a medical abortion or by aspiration under LA, knowing the predictive factors of pain highlighted by two studies carried out in 2011. (time frame: From the abortion to the follow-up visit two to four weeks after the abortion). 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 13 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.