Clinical trial NCT05765188: Impact of Age at Conization on Obstetrical Outcome: A Case-Control Study
Official title: Impact of Age at Conization on Obstetrical Outcome: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Complications
Keywords: LEEP
preterm labor
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* female pregnant
* underwent loop electrosurgical excision procedure during the studied period
* delivered in their institution

Exclusion Criteria:

* patients having delivered elsewhere after loop electrosurgical excision procedure
* Early miscarriages (\<14 weeks of amenorrhea )

Primary outcomes:
measure: occurrence of preterm adverse obstetrical event in the group of women younger than < 25 years old
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Jean Gondry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: