Impact of Age at Conization on Obstetrical Outcome: A Case-Control Study

Completed

• Conditions: Pregnancy Complications
• Interventions: Other: loop electrosurgical excision procedure

• Registration Number: NCT05765188
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-04-02
• Study Completion: 2017-04-02
• Status Verified: 2018-09
• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-13
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

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 )

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
< 25 years	loop electrosurgical excision procedure	42 patients younger than 25 years at the time of loop electrosurgical excision procedure
> 25 years	loop electrosurgical excision procedure	73 patients 25 years or older at the time of loop electrosurgical excision procedure

Primary Outcome Measures

Name	Time	Method
occurrence of preterm adverse obstetrical event in the group of women younger than < 25 years old	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.