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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Completed
CT.gov ID
NCT05765188
Collaborator
(none)
115
27

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
115 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Impact of Age at Conization on Obstetrical Outcome: A Case-Control Study
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Apr 2, 2017
Actual Study Completion Date :
Apr 2, 2017

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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 )

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Jean Gondry, MD, PhD, CHU AMIENS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT05765188
Other Study ID Numbers:
  • PI2017_843_0049
First Posted:
Mar 13, 2023
Last Update Posted:
Mar 13, 2023
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 13, 2023