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

Pain Clinical Trial

Official title:

Assessment of Pain During Voluntary Termination of Pregnancy Following Consideration of Predictive Factors of Pain, With and Without an Established Analgesic Protocol.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05532085
• Other study ID #: ED-IVG
• Status: Completed
• Start date: June 12, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2022
• Source: University Paris 7 - Denis Diderot
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Induced Abortion
• Medical Abortion
• Pain
• Surgical Abortion

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Centre d'Interruption Volontaire de Grossesse et de Contraception de l'Hôpital Louis Mourier	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Olivier CHASSANY

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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