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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pain; Medical Abortion; Induced Abortion; Surgical Abortion
• Intervention / Treatment: Other: 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 pain during a voluntary medical termination of pregnancy following consideration of predictive factors of pain with an established 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 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 protocol

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 Type: Observational
• Enrollment (Actual): 362

Contacts and Locations

Study Locations

• France
  • Colombes, France, 92700
    • Centre d'Interruption Volontaire de Grossesse et de Contraception de l'Hôpital Louis Mourier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 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; 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: 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; 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 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From the abortion to the follow-up visit two to four weeks after the abortion

Collaborators and Investigators

• Sponsor: Olivier CHASSANY
• Investigators: Study Director: Catherine Soulat, docteur, CIVG hôpital Louis Mourier

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: September 3, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Analgesics
• Other Study ID Numbers: ED-IVG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No