An observational study in Hydatidiform Mole, sponsored by Obstetrics & Gynecology Hospital of Fudan University. Recruiting at 14 sites in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Observational
This observational study aims to establish a national cohort of patients with hydatidiform mole (molar pregnancy) to investigate its malignant transformation rate and malignant transformation mechanisms, with the goal of developing and promoting precision diagnosis and treatment models across China.
This study will enrol women with a confirmed hydatidiform mole who have undergone uterine evacuation. Candidates must possess complete clinical and pathological records and show no myometrial invasion or distant metastasis at baseline. We will exclude those with concurrent malignancy, severe autoimmune or infectious disease, or significant psychiatric illness. Longitudinal follow-up will track malignant transformation (post-molar gestational trophoblastic neoplasia per FIGO criteria), reproductive outcomes, and health-related quality of life. By establishing a large, nationwide, multicentre cohort, we aim to clarify the epidemiology, pinpoint risk factors for malignant progression, and evaluate long-term reproductive and psychosocial outcomes in this population.
Exclusion Criteria:
This cohort aims to support the development of evidence-based precision management strategies and facilitate nationwide promotion of optimal care practices for molar pregnancy.
Other: No intervention
No intervention
Malignant transformation of hydatidiform mole
Diagnosed with pGTN according to the FIGO guideline diagnostic criteria
Time frame: Postoperative b-hCG levels were monitored every 1-2 weeks. While patients with PHM could discontinue follow-up after b-hCG normalization, those with CHM- given their higher risk of malignant progression- require monthly monitoring for 6 months following
Fertility outcomes
Reproductive outcomes such as pregnancy rate, live birth rate, and miscarriage rate, following the uterine evacuation of the current molar pregnancy.
Time frame: 1 year and 2 year
Hospital Anxiety and Depression Scale (HADS)
ordinal scale, range: 0-3, higher scores means a worse outcome
Time frame: Pathological diagnosis, 3 months after uterine evacuation
Reproductive Concerns After Cancer (RCAC)
ordinal scale, range: 1-5, higher scores mean a better outcome
Time frame: Pathological diagnosis, 3 months after uterine evacuation
Plan to share: No
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Hydatidiform Mole
Obstetrics & Gynecology Hospital of Fudan University