- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07650071
PS IVG : Psychosocial Determinants of Late-term Abortions (14-16 Weeks' Gestation) at Avignon Hospital (PS IVG)
June 10, 2026 updated by: Centre Hospitalier Henri Duffaut - Avignon
Abortion is a fundamental right for women in France, where the legal time limit was extended from 14 to 16 weeks' gestation.
This extension allows women, whose psychosocial determinants are poorly known, and who face various obstacles (personal, administrative, medical, or other), to access abortion.
However, it may also expose them to psychological troubles and difficulties in accessing healthcare.
This study aims to identify the psychosocial determinants and disruptions in the primary care pathway associated with late abortions (≥14 weeks' gestation [WG]) in order to propose preventive actions, particularly regarding contraception, screening, and referral, directly applicable in general practice.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marilyne Grinand, PhD
- Phone Number: (+33)432759392
- Email: grinand.marilyne@ch-avignon.fr
Study Locations
-
-
-
Avignon, France, 84000
- Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
-
Contact:
- Marilyne Grinand, PhD
- Phone Number: (+33)0432759392
- Email: grinand.marilyne@ch-avignon.fr
-
Principal Investigator:
- Perrine Mazet, MD
-
Sub-Investigator:
- Margaux Deplaix, Intern
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient aged ≥ 18 years
- Pregnancy ≥ 14 weeks' gestation
- Patient attending Avignon Hospital for a surgical abortion
- Willing to participate in the study
Exclusion Criteria:
- Medical abortion (non-surgical means of abortion)
- Ectopic pregnancy
- Inability to complete the questionnaire
- Patients under legal protection measures (guardianship, curatorship, or court-ordered protection)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health survey
This is a health survey.
Following patient recruitment, the physician will explain the study and its objectives.
If the patient agrees to participate, a QR code will be provided to allow anonymous access to the study questionnaire.
The patient will be invited to complete the questionnaire after the medical consultation.
|
It consists of a single anonymous questionnaire, to be completed once only, on a secure online platform, accessed using a QR code provided directly by the healthcare professional. The questionnaire consists of 39 main questions, predominantly with closed-ended response options. The average completion time is estimated between 10 and 20 minutes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Describe the sociodemographic profile of patients undergoing late-term abortion at Avignon Hospital.
Time Frame: Inclusion
|
Inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of patients who attended the hospital for a late-term abortion following a general practitioner's recommendation.
Time Frame: Inclusion
|
Inclusion
|
|
Proportion of patients who involved their general practitioner in the care pathway for late-term abortions.
Time Frame: Inclusion
|
Inclusion
|
|
Descriptive analysis of patients' medical follow-up, medical history and contraceptive practices.
Time Frame: Inclusion
|
Inclusion
|
|
Frequency of reasons leading to pregnancy and circumstances of pregnancy discovery.
Time Frame: Inclusion
|
Inclusion
|
|
Descriptive analysis of patients' relationships with their entourage regarding this pregnancy (partner, family, healthcare professionals, etc.).
Time Frame: Inclusion
|
Inclusion
|
|
Frequency of reasons for choosing abortion.
Time Frame: Inclusion
|
Inclusion
|
|
Frequency of late-term abortions performed with the support of a general practitioner.
Time Frame: Inclusion
|
Inclusion
|
|
Frequency of late abortions performed under coercion.
Time Frame: Inclusion
|
Inclusion
|
|
Frequency of late abortions related to issues in the care pathway.
Time Frame: Inclusion
|
Inclusion
|
|
Descriptive analysis of patients' difficulties in accessing this type of healthcare.
Time Frame: Inclusion
|
Inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Perrine Mazet, MD, Centre Hospitalier d'Avignon, Service de Gynécologie
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 15, 2026
Primary Completion (Estimated)
June 15, 2027
Study Completion (Estimated)
September 15, 2027
Study Registration Dates
First Submitted
June 10, 2026
First Submitted That Met QC Criteria
June 10, 2026
First Posted (Actual)
June 16, 2026
Study Record Updates
Last Update Posted (Actual)
June 16, 2026
Last Update Submitted That Met QC Criteria
June 10, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PS 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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