Pregnancy, UnwantedNCT04830007
Factors Associated With the Absence of Contraception at Women Seeking a Voluntary Termination of Pregnancy
An observational study of Pregnancy, Unwanted, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
The study will be offered to all women who are consultant for an abortion plan are seen in consultation at the orthogeny center where the study will be conducted. Of these 700 women, about 10% will not agree to participate in the study and 10% will not meet the inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Unwanted
- How many people
- 560 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2022to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Protocol proposed to woman who wanted a voluntary termination of pregnancy
Who may be able to join
- woman of 18 years of age or older;
- Being French-speaking;
- request for a medical or instrumental voluntary termination of pregnancy
- No opposition to participation in the protocol
- Be affiliated with a social security plan
Who cannot join
- desired pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With the Absence of Contraception at the Time of Unplaned Pregnancy Among Women Seeking a Voluntary Termination of Pregnancy
The study will be offered to all women who are consultant for an abortion plan are seen in consultation at the orthogeny center where the study will be conducted. Of these 700 women, about 10% will not agree to participate in the study and 10% will not meet the inclusion criteria. Thus it's plane to include 560 patients in the study.
Read the detailed description
In 1967, the Neuwirth law allowed women to control their fertility by establishing the right to contraception as a principle. Since then, they have continued to take ownership of the various contraceptive methods, which are regularly renewed.
Contraceptive coverage is important in France as it is estimated that 92% of women of childbearing age use a contraceptive method. The pill remains the most widely used method of contraception (36.5%), ahead of the intrauterine device (25.6%) condoms (15.5%) Several laws have been introduced from 1967 to today to facilitate access to sexual health care: screening for sexually transmitted infections, free provision of emergency contraception to minors, non-prescription delivery of emergency contraception, free consultation at a family planning and education center, voluntary termination of pregnancy 100%, reimbursement of condoms by social security.
Despite all the measures put in place, it is now clear that the number of unplanted pregnancies is decreasing slightly and the number of abortion has remained stable since 2001.
According to the latest literature data, several socio-demographic factors appear to play a role in the rate of use of voluntary termination of pregnancy., including age, socio-cultural level, marital and economic status and ethnic origin. All the more striking, it appears that while voluntary termination of pregnancy are mainly related to contraceptive failures, one third of them involve women who do not have contraception. According to the latest Ined survey, and in accordance with other data from the literature, the factors associated with the absence of contraceptive use are multiple: ignorance about fertility, family or cultural context, cost of contraceptive methods or lack of information related to them.
While these studies have looked at the reasons given by women for the lack of contraception, with little data on the characteristics of these women, particularly socio-demographics and their reproductive history and in particular in the context of unwanted pregnancy. This finding leads us to question the factors associated with the absence of contraception among women in demand of a voluntary termination of pregnancy.
- Conditions
- Pregnancy, Unwanted
- Keywords
- Contraception, Abortion, Unplanned pregnancy, Unintended pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between absence of contraception and socio-demographic factors, characteristics of pregnancy abortion and medical follow-up
Statistically significant association between the absence of contraception in patients consulting for a voluntary termination of pregnancy and socio-demographic factors, characteristics of voluntary termination of pregnancy abortion and characteristics related to medical follow-up
Measured: 1 hour
Secondary outcomes (7)
Prescription and dispensing of contraception
Prevalence of patients informed about the prescription and dispensing of contraception including emergency contraception
Measured: 1 hour
Existence of family planning centers
Prevalence of patients informed about the existence of family planning centers
Measured: 1 hour
Emergency contraception
Prevalence of women who have used emergency contraception
Measured: 1 hour
Price and reimbursement of condoms
Prevalence of women informed about the price and reimbursement of condoms
Measured: 1 hour
Knowledge of conception
Estimate the percentage of women who thought they could get pregnant at the time of the intercourse that led to this pregnancy
Measured: 1 hour
Fertile window
Prevalence of women who use a method to track their fertile window
Measured: 1 hour
Affection of fertility
Estimate the percentage of women who think that contraception can affect their fertility
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study startNov 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: Investigator coordinatoor left the site and the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, UnwantedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830007
- Sponsor's protocol ID
- NOCONTRAIVG
- Other IDs
- 2021-A00298-33
- Status last verified
- Jan 2022
- First submitted
- 11 Feb 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With the Absence of Contraception at the Time of Unplaned Pregnancy Among Women Seeking a Voluntary Termination of Pregnancy
- ClinicalTrials.gov ID
- NCT04830007
- Acronym / sponsor ID
- NOCONTRAIVG
- Conditions
- Pregnancy, Unwanted
- Keywords
- Contraception, Abortion, Unplanned pregnancy, Unintended pregnancy
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Investigator coordinatoor left the site and the trial
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be offered to all women who are consultant for an abortion plan are seen in consultation at the orthogeny center where the study will be conducted. Of these 700 women, about 10% will not agree to participate in the study and 10% will not meet the inclusion criteria. Thus it's plane to include 560 patients in the study.
Detailed description
In 1967, the Neuwirth law allowed women to control their fertility by establishing the right to contraception as a principle. Since then, they have continued to take ownership of the various contraceptive methods, which are regularly renewed.
Contraceptive coverage is important in France as it is estimated that 92% of women of childbearing age use a contraceptive method. The pill remains the most widely used method of contraception (36.5%), ahead of the intrauterine device (25.6%) condoms (15.5%) Several laws have been introduced from 1967 to today to facilitate access to sexual health care: screening for sexually transmitted infections, free provision of emergency contraception to minors, non-prescription delivery of emergency contraception, free consultation at a family planning and education center, voluntary termination of pregnancy 100%, reimbursement of condoms by social security.
Despite all the measures put in place, it is now clear that the number of unplanted pregnancies is decreasing slightly and the number of abortion has remained stable since 2001.
According to the latest literature data, several socio-demographic factors appear to play a role in the rate of use of voluntary termination of pregnancy., including age, socio-cultural level, marital and economic status and ethnic origin. All the more striking, it appears that while voluntary termination of pregnancy are mainly related to contraceptive failures, one third of them involve women who do not have contraception. According to the latest Ined survey, and in accordance with other data from the literature, the factors associated with the absence of contraceptive use are multiple: ignorance about fertility, family or cultural context, cost of contraceptive methods or lack of information related to them.
While these studies have looked at the reasons given by women for the lack of contraception, with little data on the characteristics of these women, particularly socio-demographics and their reproductive history and in particular in the context of unwanted pregnancy. This finding leads us to question the factors associated with the absence of contraception among women in demand of a voluntary termination of pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Protocol proposed to woman who wanted a voluntary termination of pregnancy
Key inclusion criteria (5 listed)
- woman of 18 years of age or older;
- Being French-speaking;
- request for a medical or instrumental voluntary termination of pregnancy
- No opposition to participation in the protocol
- Be affiliated with a social security plan
Key exclusion criteria (1 listed)
- desired pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between absence of contraception and socio-demographic factors, characteristics of pregnancy abortion and medical follow-up
Time frame: 1 hour
Statistically significant association between the absence of contraception in patients consulting for a voluntary termination of pregnancy and socio-demographic factors, characteristics of voluntary termination of pregnancy abortion and characteristics related to medical follow-up
7 secondary outcomes
Prescription and dispensing of contraception
Time frame: 1 hour
Existence of family planning centers
Time frame: 1 hour
Emergency contraception
Time frame: 1 hour
Price and reimbursement of condoms
Time frame: 1 hour
Knowledge of conception
Time frame: 1 hour
Fertile window
Time frame: 1 hour
Affection of fertility
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, Unwanted, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between absence of contraception and socio-demographic factors, characteristics of pregnancy abortion and medical follow-up (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.