Study Overview
This prospective, single-arm, clinical trial study was conducted at a tertiary educational referral hospital affiliate to Tehran University of Medical Sciences between September 2018 and September 2019. All participants suspected with hydatidiform were recruited in the study. Lab data such as kidney, liver and thyroid function test, complete blood count (CBC) and electrolytes was obtained. Indeed, beta-hCG titer was measured as baseline. An abdomino-pelvic ultrasound performed to find any evidence of an invasive mole, exclude a coexisting pregnancy, and look for possible metastatic disease. Chest radiography was ordered for all patients.
In the participants who wanted to preserve fertility, uterine evacuation performed. After dilatation, the molar tissue was evacuated with suction cannula 9 gauge and sharp curettage by curette at the end of the procedure.
International Federation of Gynecologists and Obstetricians (FIGO) standardized created criteria to follow the gestational trophoblastic disease (14):
- Beta- hCG plateau four values ±10% recorded over a 3-week duration.
- Elevated beta- hCG level more than 10% of three values recorded over a 2-week duration
- Detectable beta- hCG for more than 6 months after evacuation.
In the follow-up period, patients were visited every week and the beta-hCG was measured by cobas analyzer for free beta subunit by ECL (Electrochemiluminescence). In persisted PGD according to the mentioned criteria, hysteroscopy was performed by surgeon with 15 years’ experience in the field of hysteroscopy, with 26 F Karl Storz bipolar resectoscope fitted with an 8 mm cutting loop. Saline was used to distend the uterine cavity by controlling the amount of fluid (by means of Hysteroflator). By using the loop as the curettage, trophoblastic tissues were removed by gentle motions without current application. We did not use misoprostol or prostaglandins for cervical preparing. Seven days after the procedure, beta-hCG was evaluated again.
Primary outcome was evaluation of changing in beta-hCG levels after 1 and 7 days (a 10 log reduction regarding the primary levels). Secondary outcome was evaluation of the endometrial cavity for PGTD 7 days after the procedure by transvaginal ultrasound (Siemens probe, by a same radiologist who performed the first TVS). If beta-hCG had a plateaued or non-decreasing trend (<a 10 log reduction), the patient was candidate for chemotherapy. All the participants followed by measuring beta-hCG levels for 6 months, until the levels would be undetectable.
Ethical statements
All participants sign the written informed consent. The oncologist explained the potential pros and cons of hysteroscopic resection and the advantages and disadvantages of chemotherapy as an alternative treatment. Participants could choose the treatment modality on that appointment or informed the authors at separate session to accept or reject the trial. The study had been approved by TUMS ethics committee (Reference Number: 27546-30-03-94). It was registered in Iranian Registry of Clinical Trials (IRCT), (Reference Number: IRCT201601222576N11, 8/2016). This trial was conducted according to the principles of the Helsinki Declaration.
Inclusion and exclusion criteria
Inclusion criteria were the history of hydatidiform mole that beta-hCG titer in the follow-up did not reach negative value after uterine evacuation or the detecting PGTD in uterus by ultrasound. They were all eager to participate in the study. Exclusion criteria were patients who preferred chemotherapy instead of hysteroscopy.
Statistical analysis
Data analysis was conducted by means of STATA version 14. (StataCorp, College Station, TX, USA). The Mann Whitney U test was used for data analysis. P value less than 0.05 considered significant. A CONSORT guideline was used for reporting the results.