Incomplete Miscarriage Clinical Trial
— HY-PEROfficial title:
Assessment of the Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions
Verified date | July 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 577 |
Est. completion date | July 3, 2020 |
Est. primary completion date | November 15, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
Inclusion Criteria: - Major, under 45 years with intrauterine trophoblastic retention after incomplete miscarriage in the first quarter (termination of pregnancy < 14 WA), - With desire of pregnancy ; - Intrauterine trophoblastic retention diagnosed by transvaginal pelvic ultrasound finding a intrauterine heterogeneous image or intrauterine gestational sac more than 15 mm in thickness, complicated or not of endometritis ; - Decision to surgical management of incomplete miscarriage by the health care team ; - Patient beneficiary or affiliated to a health insurance - Informed and signed consent Exclusion Criteria: Will not be included in the protocol patients : - having a uterine malformation known ; - having received surgical treatment for the current intrauterine retention ; - with intrauterine retention diagnosed by transvaginal pelvic ultrasound of more than 50 mm in thickness ; - requiring a haemostatic act in urgency for heavy vaginal bleeding (miscarriage haemorrhage) ; - bearer of intrauterine device ; - having an evolutive pregnancy; - having an ectopic pregnancy; - having a trophoblastic retention following a voluntary abortion ; - having a pregnancy achieved by medically assisted procreation |
Country | Name | City | State |
---|---|---|---|
France | Centre hospitalier intercommunal de poissy-saint germain en Laye | Poissy |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progressive intrauterine pregnancy > 22 WA | Questionnaire | Until 2 years post surgery | |
Secondary | Next pregnancy | Until 2 years post surgery | ||
Secondary | Surgical complications' rate | Clavien-Dindo classification | until 2 years post surgery | |
Secondary | Surgical reinterventions | until 2 years post surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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