About this trial
Early pregnancy loss occurs in \~15% of pregnancies. The treatment options include surgical uterine evacuation by suction curettage, medical management with misoprostol, or conservative management without interventions. The advantages of surgical management include quick resolution of the pregnancy and avoidance of heavy vaginal bleeding, while the disadvantages include retained products of conception and intrauterine adhesion formation which could affect future fertility. With the aim of reducing the complications of suction curettage, uterine evacuation using operative hysteroscopy has been suggested.
In a previous study, the investigators compared suction curettage with operative hysteroscopy for the surgical management of early pregnancy loss up to 10 weeks of gestation. The results showed significantly reduced adhesions rate (4.2% in the hysteroscopy group vs. 45.2% in the suction group, p \< 0.01), although the operative time was significantly longer for the hysteroscopy.
In this follow-up study, the investigators will compare the outcomes of hysteroscopy and suction curettage in a select group of patients with early pregnancy loss following conception by in-vitro fertilization. These patients are at risk for adhesions and therefore candidates for the hysteroscopic intervention. The study will include 50 patients randomized to 2 intervention arms - hysteroscopy using a tissue removal device versus the standard suction curettage. Post-operative adhesions will be assessed by office hysteroscopy after 6-8 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of early pregnancy loss up to 10 weeks' gestation, based on last menstrual period or ultrasound.
Pregnancy conceived through assisted reproductive techniques (in vitro fertilization, IVF).
Ability to provide informed consent, and proficiency in reading and writing Hebrew.
Disqualifiers
Heavy vaginal bleeding or diagnosis of incomplete abortion.
Signs of infection and/or suspicion of septic abortion
Known uterine anomalies- including septate, bicornuate, unicornuate, or didelphys uterus.
Prior medical or surgical treatment during the current pregnancy
Trial design
Parallel
Treatments tested in this trial
Operative hysteroscopy using tissue removal device
DeviceOperative hysteroscopy using tissue removal device
suction curettage
Devicesuction curettage using plastic scution curette
Treatment groups
Trial outcomes
Primary outcomes
Intrauterine adhesions
Post-operative intrauterine adhesions will be evaluated by office diagnostic hysteroscopy after 6-8 weeks. The physician performing the office hysteroscopy will be blinded to the patient's intervention arm. The intrauterine adhesions will be classified according to the American Fertility Society score (from 0 to 12, higher scores means worse adhesions).
Time to pregnancy
The patient's reproductive outcomes will be assessed by telephone interview after 6 and 12 months from the intervention.
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