Randomizedtrial comparing success and complication rates of operative hysteroscopy versus traditional dilation and curettage (D\&C) in the management of first trimester missed abortion.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy
Separation of the non-viable gestational sac from the uterine wall through dilation and curettage
Operative hysteroscopy - safety and feasibility phase
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
RECRUITINGIntrauterine adhesions (IUA)
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
Time frame: 2 months
Retained product of conception (RPOC)
RPOC rate in repeat ultrasound scan performed 8 weeks after primary treatment
Time frame: 2 months
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