Assessment of Pain During an Abortion With Knowledge of the Predictive Factors of Pain.

NCT05532085 | Completed

• 1 other identifier: ED-IVG
• Study Type: observational
• Target: 362
• Locations: 1 country
• Sites: 1

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.

Conditions

Induced Abortion; Medical Abortion; Surgical Abortion; Pain

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  From the abortion to the follow-up visit two to four weeks after the abortion

Study Arms (4)

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.

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.

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.

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.

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

Interventions

Evaluation of pain during voluntary termination of pregnancy with medication following consideration of predictive factors of pain without an established analgesic protocol OTHER

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.

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 protocol OTHER

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.

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 protocol OTHER

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.

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 protocol OTHER

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.

Group: Abortion by aspiration under local anesthesia with analgesic protocol

Eligibility Criteria

• Age: 15 Years - 70 Years
• Gender Eligibility Details: Study on voluntary termination of pregnancy.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All women over the age of 15, benefiting from a medical abortion or by aspiration under local anesthesia.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Olivier CHASSANY: lead

Study Sites (1)

Centre d'Interruption Volontaire de Grossesse et de Contraception de l'Hôpital Louis Mourier

Colombes, 92700, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine Soulat, docteur

  CIVG hôpital Louis Mourier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: September 8, 2022
• Study Start: June 12, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)