Spontaneous Abortion, Missed Abortion, Intrauterine Adhesion, Retained Products of Conception
Conditions
Brief summary
Randomizedtrial comparing success and complication rates of operative hysteroscopy versus traditional dilation and curettage (D&C) in the management of first trimester missed abortion.
Detailed description
A randomized controlled trial (RCT) of women diagnosed with first trimester spontaneous abortion. Participants interested in operative evacuation of the uterus will be randomized to either operative hysteroscopy or dilation an curettage (D&C). Study population will include pregnant women diagnosed with first trimester spontaneous abortion of up to 13+0 weeks from last menstrual period (LMP) or up to 11+0 weeks of gestation as determined by Crown-Rump Length (CRL). Women who will electively choose to terminate their pregnancy as well as women diagnosed with threatened, incomplete or inevitable abortion will be excluded. All participants will undergo diagnostic hysteroscopy 6-8 weeks after allocated treatment in order to rule out intrauterine adhesion formation and retained product of conception. The primary outcome measure is the risk of intrauterine adhesion formation.
Interventions
PROCEDUREOperative Hysteroscopy
Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy
PROCEDURED&C
Separation of the non-viable gestational sac from the uterine wall through dilation and curettage
PROCEDUREOperative Hysteroscopy - safety and feasibility
Operative hysteroscopy - safety and feasibility phase
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women diagnosed with missed abortion who choose to undergo surgical evacuation. and who are at gestational age of 5+0 weeks to 11+0 weeks from last menstrual period (LMP).
Exclusion criteria
* women who electively choose to terminate pregnancy * women who took medical treatment for missed abortion prior to recruitment * women with known uterine abnormality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrauterine adhesions (IUA) | 2 months | IUA formation will be assessed in all participants in the follow up diagnostic hysteroscopy performed 8 weeks after the primary treatment. IUA will be classified according to the American Society for Reproductive Medicine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retained product of conception (RPOC) | 2 months | RPOC rate in repeat ultrasound scan performed 8 weeks after primary treatment |
Countries
Israel
Contacts
Primary ContactYossi Tzur, M.D.
Backup ContactGilad Rattan, M.D.
Outcome results
None listed