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

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 Overview

• Status: Completed
• Conditions: Pregnancy Complications
• Intervention / Treatment: Other: loop electrosurgical excision procedure

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 Type: Observational
• Enrollment (Actual): 115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
< 25 years; 42 patients younger than 25 years at the time of loop electrosurgical excision procedure	Other: loop electrosurgical excision procedure; 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.
> 25 years; 73 patients 25 years or older at the time of loop electrosurgical excision procedure	Other: loop electrosurgical excision procedure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Jean Gondry, MD, PhD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): April 2, 2017
• Study Completion (Actual): April 2, 2017

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: preterm labor; LEEP
• Additional Relevant MeSH Terms: Pregnancy Complications
• Other Study ID Numbers: PI2017_843_0049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No