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

NCT05765188 | Completed

• 1 other identifier: PI2017_843_0049
• Study Type: observational
• Target: 115
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy Complications

Keywords

LEEP; preterm labor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

< 25 years

42 patients younger than 25 years at the time of loop electrosurgical excision procedure

Other: loop electrosurgical excision procedure

> 25 years

73 patients 25 years or older at the time of loop electrosurgical excision procedure

Other: loop electrosurgical excision procedure

Interventions

loop electrosurgical excision procedure OTHER

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; > 25 years

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Conditions

Pregnancy Complications; Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications

Study Officials

• Jean Gondry, MD, PhD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: March 13, 2023
• Study Start: January 1, 2015
• Primary Completion: April 2, 2017
• Study Completion: April 2, 2017
• Last Updated: March 13, 2023

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share