Clinical Trial: Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Assessment of the Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions

Brief Summary: The purpose of this study of is to compare subsequent fertility rates between hysteroscopy and aspirative curettage in the surgical treatment of incomplete spontaneous abortion

Detailed Summary:

Incomplete spontaneous abortion (ISA) is defined by the intrauterine retention of conceptual product after incomplete or partial expulsion of the conceptual product. Treatment such retention may be expectant care, medical treatment or surgery. Currently, curettage is the standard surgical treatment in most centers. However, operative hysteroscopy, in addition to the direct visualization of the retained conceptual product, in contrast to the curettage, would allow elective evacuation of retention while reducing surgical complications. Studies of low effective, retrospective, have found an fertility's increase in patients treated by operative hysteroscopy. These data need to be confirmed by a randomized controlled trial in order to change the standard surgical treatment of this disease if hysteroscopy procedure would found to be superior.

We propose a multicenter - single blind - randomized - therapeutic study. Randomization will concern the surgical procedure in patients treated surgically for intrauterine retention after spontaneous miscarriage. Randomization will be performed at the admission to the patient in the operating room by electronic means using a secure internet platform, single-blind for the patient with unblinding at the end of the trial or in case of complication. The patient will be randomly assigned to one of two treatment arms following:

  • Arm A : Operative hysteroscopy
  • Arm B : Aspirative curettage The inclusion will be performed at time of diagnosis (incomplete miscarriage) with an ultrasound of intrauterine retention for which surgical treatment has been decided. The initial medical examination (inclusion visit) will include a complete gynecological examination. The diagnosis of incomplete miscarriage will be performed using a transvaginal
    Sponsor: Assistance Publique - Hôpitaux de Paris

    Current Primary Outcome: Progressive intrauterine pregnancy > 22 WA [ Time Frame: Until 2 years post surgery ]

    Questionnaire


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Next pregnancy [ Time Frame: Until 2 years post surgery ]
    • Surgical complications' rate [ Time Frame: until 2 years post surgery ]
      Clavien-Dindo classification
    • Surgical reinterventions [ Time Frame: until 2 years post surgery ]


    Original Secondary Outcome: Same as current

    Information By: Assistance Publique - Hôpitaux de Paris

    Dates:
    Date Received: July 17, 2014
    Date Started: November 2014
    Date Completion: October 2019
    Last Updated: December 23, 2016
    Last Verified: December 2016