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

NCT05469594 | Completed

• 1 other identifier: 2022PI033-230
• Study Type: observational
• Target: 122
• Locations: 0 countries
• Sites: N/A

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

Keywords

complications

Outcome Measures

Primary Outcomes (1)

• complications

  hemorrhage, infection, retained product of conception, failure, uterine rupture

  Day 0

Secondary Outcomes (1)

• repartition of all complications

  Day 0

Study Arms (2)

Termination of pregnancy between 12-14 weeks of gestation

Termination of pregnancy between 14-16 weeks of gestation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist assistant in gynaecology and obstetrics

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 21, 2022
• Study Start: January 1, 2010
• Primary Completion: January 1, 2010
• Study Completion: October 1, 2021
• Last Updated: July 21, 2022

Record last verified: 2022-07