Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions
Condition: Incomplete Miscarriage
MeSH terms: Abortion, Spontaneous; Abortion, Incomplete
Study type: Interventional

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 description: 
      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 pelvic ultrasound. Transvaginal ultrasound will
           be performed according to a technique of standardized pelvic ultrasound ; the retention
           will be diagnosed in the presence of a heterogeneous image or intrauterine gestational
           sac more than 15 mm in thickness. On this visit, the patient will complete a
           questionnaire concerning her medical histories and the aborted pregnancy.

      Patients will have a care in accordance with center practices for the hospital stay. Surgical
      treatment will be performed within the time depending on the availability of the operating
      room of participating center.

      A hospitalization report indicating the participation to the study, but not mentioning the
      treatment group, will be sent to the attending physician and the patient. An information form
      with postoperative instructions will be given to patients included in this protocol without
      mentioning the surgical arm. The operative report will be given to the patient at the end of
      her participation in the trial.

      A total of five visits (including final visit) are scheduled for this trial. The patient will
      be monitored in the form of telephone conversation or questionnaire sent by email or post.
      Monitoring will be done by the investigator that enrolled the patient with the help of the
      URC in charge of the project. In case of complications, failure of the intervention or
      diagnosis of a uterine cavity pathology, the care will be left to the discretion of the
      medical center team.
    

Intervention name(s): Hysteroscopy; Curettage
Intervention type(s): Procedure; Procedure
Intervention description(s): Performed under general or local anesthesia, antibioprophylaxis in accordance to center practices may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.; Performed under general or local anesthesia, the used material may be rigid or flexible vacurette. In the same way, the prophylactic antibiotic, the diameter of the used vacurette, the importance of cervical dilation necessary and a possible peroperative ultrasound guidance will be left at the discretion of the operator and habits of the center. A check of the uterine vacuity by foam curette will be conducted at the end of curettage.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Incomplete miscarriage; Hysteroscopy; curettage, pregnancy; RCT