Abortion in First TrimesterNCT05469594
Second-trimester TOP : a Retrospective Study Comparing Complications at 12-14 vs 14-16 Weeks of Gestation
An observational study of Abortion in First Trimester and Abortion, Second Trimester, run by Central Hospital, Nancy, France.
Trial summary
In France, the recently adopted law relating to the legal time limit for access to voluntary interruption of pregnancy has set a threshold of the term at which it can be performed up to 16 weeks of gestation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion in First Trimester, Abortion, Second Trimester
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Oct 2021
- 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: women of childbearing age, major, with a single pregnancy who underwent for termination of pregnancy for medical reasons (maternal or foetal) between 12 and 16 weeks of gestation.
Who may be able to join
- termination of pregnancy for a medical reason
- between 12 and 16 weeks of gestation
- singleton pregnancy
Who cannot join
- multiple pregnancy
- abortion occurred before the induction of termination of pregnancy
About this study
Official title: Second-trimester Termination of Pregnancy: A Retrospective Study Comparing Complications Related to Termination of Pregnancy at 12-14 Weeks' Gestation Versus 14-16 Weeks' Gestation
In France, the recently adopted law relating to the legal time limit for access to voluntary interruption of pregnancy has set a threshold of the term at which it can be performed up to 16 weeks of gestation. This single-centre study conduced at the Nancy Maternity Hospital is based on a retrospective cohort of all patients who underwent a medical termination of pregnancy between January 2010 and October 2021. The main objective is to evaluate the complications according to the term of the termination of pregnancy between two groups : [12-14] vs [14-16] weeks of gestation. The secondary objective is the distribution of these complications between the two groups. Pregnancy termination can be performed in two methods, either by medical method with mifepristone and misoprostol, or by surgical method by dilation and evacuation. Complications identified are haemorrhage, infection, retained product of trophoblast, uterine rupture and abortion induction failure. The hypothesis is the concomitant increase in complications with the term of the termination of pregnancy.
- Keywords
- complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Termination of pregnancy between 12-14 weeks of gestation | Not described | |
| Termination of pregnancy between 14-16 weeks of gestation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
hemorrhage, infection, retained product of conception, failure, uterine rupture
Measured: Day 0
Secondary outcomes (1)
repartition of all complications
repartition of all complications between groups
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study startJan 2010
- Primary completionJan 2010
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion in First TrimesterStudies 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
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin GUILLEZ, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469594
- Sponsor's protocol ID
- 2022PI033-230
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second-trimester Termination of Pregnancy: A Retrospective Study Comparing Complications Related to Termination of Pregnancy at 12-14 Weeks' Gestation Versus 14-16 Weeks' Gestation
- ClinicalTrials.gov ID
- NCT05469594
- Acronym / sponsor ID
- 2022PI033-230
- Keywords
- complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jan 2010 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 21 Jul 2022 (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.
In France, the recently adopted law relating to the legal time limit for access to voluntary interruption of pregnancy has set a threshold of the term at which it can be performed up to 16 weeks of gestation. This single-centre study conduced at the Nancy Maternity Hospital is based on a retrospective cohort of all patients who underwent a medical termination of pregnancy between January 2010 and October 2021. The main objective is to evaluate the complications according to the term of the termination of pregnancy between two groups : [12-14] vs [14-16] weeks of gestation. The secondary objective is the distribution of these complications between the two groups. Pregnancy termination can be performed in two methods, either by medical method with mifepristone and misoprostol, or by surgical method by dilation and evacuation. Complications identified are haemorrhage, infection, retained product of trophoblast, uterine rupture and abortion induction failure. The hypothesis is the concomitant increase in complications with the term of the termination of pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Termination of pregnancy between 12-14 weeks of gestation | – | – |
| Termination of pregnancy between 14-16 weeks of gestation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women of childbearing age, major, with a single pregnancy who underwent for termination of pregnancy for medical reasons (maternal or foetal) between 12 and 16 weeks of gestation.
Key inclusion criteria (3 listed)
- termination of pregnancy for a medical reason
- between 12 and 16 weeks of gestation
- singleton pregnancy
Key exclusion criteria (2 listed)
- multiple pregnancy
- abortion occurred before the induction of termination of 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
complications
Time frame: Day 0
hemorrhage, infection, retained product of conception, failure, uterine rupture
1 secondary outcome
repartition of all complications
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion in First Trimester and Abortion, Second Trimester, run by Central Hospital, Nancy, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
complications (time frame: Day 0). 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 21 Jul 2022; AzTrials last refreshed its copy on 29 Oct 2026.