Pharmacological Voluntary Termination of Pregnancy: Predictors of Pelvic Pain During Treatment

NCT06800287 | Completed

• 1 other identifier: IVG - OS
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

Pharmacological treatment for voluntary termination of pregnancy is a safe and effective practice, but has as its limitation a greater need for analgesic coverage than surgical treatment. Despite this, to date there are no specific guidelines on the management of pain therapy during pharmacological voluntary termination of pregnancy and in particular on its correlation with gestational age at the time of treatment. The aim of the study is to investigate the correlation between the pain symptoms reported by the patients and the gestational age at the time of the pharmacological voluntary interruption of pregnancy and to identify the presence of possible predictive factors, in order to be able to outline the correct therapeutic management.

Conditions

Pregnancy Related

Keywords

pelvic pain; ivg; predictive factors; pregnancy; voluntary interruption of pregnancy; pharmacological treatment

Outcome Measures

Primary Outcomes (1)

• Pain symptoms of patients undergoing pharmacological IVG

  Assessing the pain symptoms of patients undergoing pharmacological IVG recorded according to the Visual Analog Scale (VAS) scale and the need for additional analgesic therapy (rescue dose), in relation to certain variables such as the patient's age, gestational age, anxiety trait and pre-procedure anxiety state of the patients assessed by means of scientifically validated questionnaires. \- VAS questionnaire: 0-100 numeric scale to record the patient's pain symptoms. 0 is considered the absence of pain, ≤ 40 tolerable pain (not requiring supplementary therapy), \> 40 ≤ 70 intense pain (responsive to required supplementary therapy), \> 70 intolerable pain not responsive to required supplementary therapy, 100 maximum pain perceived in the patient's life.

  48 hours after the administration of mifepristone and after an observation period of not less than 3 hours

Secondary Outcomes (1)

• Patient satisfaction

  48 hours after the administration of mifepristone and after an observation period of not less than 3 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requesting a pharmacological voluntary termination of pregnancy, according to Law 194 of 1978

You may qualify if:

• Patients over 18 years of age
• IVG certificate issued by the doctor and signed by the woman
• Informed consent for drug treatment
• Informed consent for the study in question
• Pregnancy in utero with ultrasound date less than or equal to 63 days

You may not qualify if:

• Suspected extrauterine pregnancy or adnexal masses of undefined diagnosis
• IUD in place
• Severe anaemia
• Hereditary porphyria
• Coagulopathy or ongoing treatment with anticoagulants
• Ongoing treatment with corticosteroids or adrenal insufficiency

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

Azienda USL di Bologna

Bologna, Bologna, 40138, Italy

Location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Renato Seracchioli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 30, 2025
• Study Start: July 13, 2021
• Primary Completion: April 30, 2024
• Study Completion: November 25, 2024
• Last Updated: January 30, 2025

Record last verified: 2024-11

Locations

IT (2)