Incomplete Miscarriage Clinical Trial
Official title:
Assessment of the Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions
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
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05516810 -
The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles
|