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

Pregnancy Complications Clinical Trial

— OBSTETRICON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05765188
• Other study ID #: PI2017_843_0049
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: April 2, 2017

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: April 2, 2017
• Est. primary completion date: April 2, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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