Pregnancy ComplicationsOBSTETRICONNCT05765188
Impact of Age at Conization on Obstetrical Outcome: A Case-Control Study
An observational study of Pregnancy Complications, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The maternity ward attached to the colposcopy clinic was also the obstetrical referral center for the region and carried out approximately 2500 deliveries per year. The aim of the study was to assess whether an age younger than 25 years at conization affected future pregnancy outcome as an independent factor. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- loop electrosurgical excision procedure
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to 2 Apr 2017
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The investigators recruited all patients who underwent loop electrosurgical excision procedure during the studied period and subsequently delivered in our institution. This only concerned the immediate after pregnancy: patients having delivered in our institution after having delivered elsewhere after loop electrosurgical excision procedure were excluded. Early miscarriages (<14 weeks of amenor- rhea [WA]) were also excluded. All patients were managed according to a multidisciplinary decision, based on French guidelines at the time of diagnosis.
Who may be able to join
- female pregnant
- underwent loop electrosurgical excision procedure during the studied period
- delivered in their institution
Who cannot join
- patients having delivered elsewhere after loop electrosurgical excision procedure
- Early miscarriages (<14 weeks of amenorrhea )
Trial locations and contacts
1 site in 1 country.
About this study
The maternity ward attached to the colposcopy clinic was also the obstetrical referral center for the region and carried out approximately 2500 deliveries per year. The aim of the study was to assess whether an age younger than 25 years at conization affected future pregnancy outcome as an independent factor. A retrospective study of 115 women who underwent both loop electrosurgical excision procedure (LEEP) and subsequent pregnancy follow-up in a referral center was conducted. Two groups were considered: patients younger than 25 years at the time of the loop electrosurgical excision procedure (n = 42) and 25 years or older (n = 73). Analyzed data were occurrence of preterm adverse obstetrical event and, specifically, preterm labor (PL) and preterm rupture of membranes; stratification based on term of occurrence was performed: less than 37 weeks of amenorrhea (WA), less than 34 WA, and less than 26 WA.
Read the detailed description
The investigators conducted a retrospective observational study between January 2008 and December 2015 in a French colposcopic referral academic hospital. The maternity ward attached to the colposcopy clinic was also the obstetrical referral center for the region and carried out approximately 2500 deliveries per year. The aim of the study was to assess whether an age younger than 25 years at conization affected future pregnancy outcome as an independent factor. A retrospective study of 115 women who underwent both loop electrosurgical excision procedure (LEEP) and subsequent pregnancy follow-up in a referral center was conducted. Two groups were considered: patients younger than 25 years at the time of the loop electrosurgical excision procedure (n = 42) and 25 years or older (n = 73). Analyzed data were occurrence of preterm adverse obstetrical event and, specifically, preterm labor (PL) and preterm rupture of membranes; stratification based on term of occurrence was performed: less than 37 weeks of amenorrhea (WA), less than 34 WA, and less than 26 WA.
- Conditions
- Pregnancy Complications
- Being tested
- loop electrosurgical excision procedure
- Keywords
- LEEP, preterm labor
- Medical subject headings
- Pregnancy Complications, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loop electrosurgical excision procedureOther
A retrospective study of 115 women who underwent both loop electrosurgical excision procedure (LEEP) and subse- quent pregnancy follow-up in a referral center was conducted.
| Study group | Role | What they receive |
|---|---|---|
| < 25 years | 42 patients younger than 25 years at the time of loop electrosurgical excision procedure Receives: Other: loop electrosurgical excision procedure | |
| > 25 years | 73 patients 25 years or older at the time of loop electrosurgical excision procedure Receives: Other: loop electrosurgical excision procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of preterm adverse obstetrical event in the group of women younger than < 25 years old
The objective of this study was to evaluate if an age younger than < 25 years old at the time of loop electrosurgical excision procedure affected future pregnancy and can have impact on th early preterm adverse obstetrical events.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Jan 2015
- Primary completion2 Apr 2017
- Study completion2 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Gondry, PU-PH, Principal investigator, CHU Amiens-Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765188
- Sponsor's protocol ID
- PI2017_843_0049
- Acronym
- OBSTETRICON
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2018
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Age at Conization on Obstetrical Outcome: A Case-Control Study
- ClinicalTrials.gov ID
- NCT05765188
- Acronym / sponsor ID
- OBSTETRICON / PI2017_843_0049
- Conditions
- Pregnancy Complications
- Keywords
- LEEP, preterm labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 2 Apr 2017 (actual)
- Study completion
- 2 Apr 2017 (actual)
- First posted
- 13 Mar 2023 (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 maternity ward attached to the colposcopy clinic was also the obstetrical referral center for the region and carried out approximately 2500 deliveries per year. The aim of the study was to assess whether an age younger than 25 years at conization affected future pregnancy outcome as an independent factor. A retrospective study of 115 women who underwent both loop electrosurgical excision procedure (LEEP) and subsequent pregnancy follow-up in a referral center was conducted. Two groups were considered: patients younger than 25 years at the time of the loop electrosurgical excision procedure (n = 42) and 25 years or older (n = 73). Analyzed data were occurrence of preterm adverse obstetrical event and, specifically, preterm labor (PL) and preterm rupture of membranes; stratification based on term of occurrence was performed: less than 37 weeks of amenorrhea (WA), less than 34 WA, and less than 26 WA.
Detailed description
The investigators conducted a retrospective observational study between January 2008 and December 2015 in a French colposcopic referral academic hospital. The maternity ward attached to the colposcopy clinic was also the obstetrical referral center for the region and carried out approximately 2500 deliveries per year. The aim of the study was to assess whether an age younger than 25 years at conization affected future pregnancy outcome as an independent factor. A retrospective study of 115 women who underwent both loop electrosurgical excision procedure (LEEP) and subsequent pregnancy follow-up in a referral center was conducted. Two groups were considered: patients younger than 25 years at the time of the loop electrosurgical excision procedure (n = 42) and 25 years or older (n = 73). Analyzed data were occurrence of preterm adverse obstetrical event and, specifically, preterm labor (PL) and preterm rupture of membranes; stratification based on term of occurrence was performed: less than 37 weeks of amenorrhea (WA), less than 34 WA, and less than 26 WA.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| < 25 years | – | Other: loop electrosurgical excision procedure42 patients younger than 25 years at the time of loop electrosurgical excision procedure |
| > 25 years | – | Other: loop electrosurgical excision procedure73 patients 25 years or older at the time of loop electrosurgical excision procedure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The investigators recruited all patients who underwent loop electrosurgical excision procedure during the studied period and subsequently delivered in our institution. This only concerned the immediate after pregnancy: patients having delivered in our institution after having delivered elsewhere after loop electrosurgical excision procedure were excluded. Early miscarriages (<14 weeks of amenor- rhea [WA]) were also excluded. All patients were managed according to a multidisciplinary decision, based on French guidelines at the time of diagnosis.
Key inclusion criteria (3 listed)
- female pregnant
- underwent loop electrosurgical excision procedure during the studied period
- delivered in their institution
Key exclusion criteria (2 listed)
- patients having delivered elsewhere after loop electrosurgical excision procedure
- Early miscarriages (<14 weeks of amenorrhea )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| loop electrosurgical excision procedureA retrospective study of 115 women who underwent both loop electrosurgical excision procedure (LEEP) and subse- quent pregnancy follow-up in a referral center was conducted. | Other | < 25 years, > 25 years |
Primary outcome
occurrence of preterm adverse obstetrical event in the group of women younger than < 25 years old
Time frame: 18 weeks
The objective of this study was to evaluate if an age younger than < 25 years old at the time of loop electrosurgical excision procedure affected future pregnancy and can have impact on th early preterm adverse obstetrical events.
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 16 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Jean Gondry, PU-PH principal investigator
CHU Amiens-Picardie
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 Complications, run by Centre Hospitalier Universitaire, Amiens 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 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 16 Jun 2026. 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?
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?
occurrence of preterm adverse obstetrical event in the group of women younger than < 25 years old (time frame: 18 weeks). 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 16 Jun 2026.