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

Second-trimester Termination of Pregnancy: A Retrospective Study Comparing Complications Related to Termination of Pregnancy at 12-14 Weeks' Gestation Versus 14-16 Weeks' Gestation

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 122

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women of childbearing age, major, with a single pregnancy who underwent for termination of pregnancy for medical reasons (maternal or foetal) between 12 and 16 weeks of gestation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Termination of pregnancy between 12-14 weeks of gestation
Termination of pregnancy between 14-16 weeks of gestation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	hemorrhage, infection, retained product of conception, failure, uterine rupture	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
repartition of all complications	repartition of all complications between groups	Day 0

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2010
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): October 1, 2021

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (ACTUAL): July 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: complications
• Other Study ID Numbers: 2022PI033-230

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No