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

Completed

• Conditions: Abortion in First Trimester; Abortion, Second Trimester

• Registration Number: NCT05469594
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2021-10
• Status Verified: 2022-07
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-20
• Last Update Submitted: 2022-07-20
• Study First Posted: 2022-07-21
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
complications	Day 0	hemorrhage, infection, retained product of conception, failure, uterine rupture

Secondary Outcome Measures

Name	Time	Method
repartition of all complications	Day 0	repartition of all complications between groups