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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT05469594
Collaborator
(none)
122
Enrollment
141
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    122 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Jan 1, 2010
    Actual Study Completion Date :
    Oct 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Termination of pregnancy between 12-14 weeks of gestation
    Termination of pregnancy between 14-16 weeks of gestation

    Outcome Measures

    Primary Outcome Measures

    1. complications [Day 0]

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

    Secondary Outcome Measures

    1. repartition of all complications [Day 0]

      repartition of all complications between groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kevin GUILLEZ, Specialist assistant in gynaecology and obstetrics, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT05469594
    Other Study ID Numbers:
    • 2022PI033-230
    First Posted:
    Jul 21, 2022
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kevin GUILLEZ, Specialist assistant in gynaecology and obstetrics, Central Hospital, Nancy, France
    complications

    Study Results

    No Results Posted as of Jul 21, 2022