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OpenTrials
Completed

NCT Number: NCT05469594

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. complications

    Time frame: Day 0

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

Secondary outcomes

  1. repartition of all complications

    Time frame: Day 0

    repartition of all complications between groups

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2021
First posted
Jul 21, 2022
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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