Clinical trial NCT05532085: Assessment of Pain During an Abortion With Knowledge of the Predictive Factors of Pain.
Official title: Assessment of Pain During Voluntary Termination of Pregnancy Following Consideration of Predictive Factors of Pain, With and Without an Established Analgesic Protocol.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Induced Abortion
Medical Abortion
Surgical Abortion
Pain
Lead sponsor: University Paris 7 - Denis Diderot
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 362
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women over the age of 15, benefiting from a medical abortion or by aspiration under local anesthesia.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: From the abortion to the follow-up visit two to four weeks after the abortion
Secondary outcomes:
measure: Highlight a significant difference in pain after application of an analgesic protocol indexed on predictive factors of pain.
timeFrame: From the abortion to the follow-up visit two to four weeks after the abortion
Other outcomes:
Locations:
city: Colombes
country: France
facility: Centre d'Interruption Volontaire de Grossesse et de Contraception de l'Hôpital Louis Mourier
Study officials:
affiliation: CIVG hôpital Louis Mourier
name: Catherine Soulat, docteur
role: STUDY_DIRECTOR
References: