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

Abortion in First Trimester Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05469594
• Other study ID #: 2022PI033-230
• Status: Completed
• Start date: January 2010
• Est. completion date: October 2021

Study information

• Verified date: July 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 2021
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion in First Trimester
• Abortion, Second Trimester

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications	hemorrhage, infection, retained product of conception, failure, uterine rupture	Day 0
Secondary	repartition of all complications	repartition of all complications between groups	Day 0