Second-trimester TOP : a Retrospective Study Comparing Complications at 12-14 vs 14-16 Weeks of Gestation

NCT ID: NCT05469594

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2021-10-31

Brief Summary

In France, the recently adopted law relating to the legal time limit for access to voluntary interruption of pregnancy has set a threshold of the term at which it can be performed up to 16 weeks of gestation. This single-centre study conduced at the Nancy Maternity Hospital is based on a retrospective cohort of all patients who underwent a medical termination of pregnancy between January 2010 and October 2021. The main objective is to evaluate the complications according to the term of the termination of pregnancy between two groups : [12-14] vs [14-16] weeks of gestation. The secondary objective is the distribution of these complications between the two groups. Pregnancy termination can be performed in two methods, either by medical method with mifepristone and misoprostol, or by surgical method by dilation and evacuation. Complications identified are haemorrhage, infection, retained product of trophoblast, uterine rupture and abortion induction failure. The hypothesis is the concomitant increase in complications with the term of the termination of pregnancy.

Conditions

Abortion in First Trimester; Abortion, Second Trimester

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Termination of pregnancy between 12-14 weeks of gestation

No interventions assigned to this group

Termination of pregnancy between 14-16 weeks of gestation

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• termination of pregnancy for a medical reason
• between 12 and 16 weeks of gestation
• singleton pregnancy

Exclusion Criteria

• multiple pregnancy
• abortion occurred before the induction of termination of pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Kevin GUILLEZ

Specialist assistant in gynaecology and obstetrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2022PI033-230

Identifier Type: -

Identifier Source: org_study_id