Clinical presentation and management of complete hydatidiform mole in women 40 or older - A study in North and South America

• Grant number: 18/10698-9
• Support Opportunities: Regular Research Grants
• Start date: December 01, 2018
• End date: November 30, 2020
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Izildinha Maestá
• Grantee: Izildinha Maestá
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil
• Associated researchers: Antônio Rodrigues Braga Neto ; Lawrence Hsu Lin ; Ross Berkowitz ; Sue Yazaki Sun

Abstract

Background. Studies have shown varying clinical presentation and initial treatment (hysterectomy or uterine evacuation) for complete hydatidiform mole (CHM) in women of advanced age ( e 40 years). Reports on these patients' clinical characteristics and response to treatment in different socioeconomic regions are still lacking. Objectives. To assess and compare complete hydatidiform mole (CHM) clinical presentation and to investigate the relationship of CHM initial treatment (hysterectomy or uterine evacuation) with the incidence of gestational trophoblastic neoplasia (GTN) and response to chemotherapy response in women e 40 years from centers in North America and South America. Methods. Retrospective cohort study that will include CHM patients e 40 years attending four South American centers in Brazil and the New England Trophoblastic Center (NETDC) in the U.S.A., between 1994 and 2017. Data collected will include information on CHM clinical characteristics, type of initial treatment (hysterectomy or uterine evacuation), GTN development, response to chemotherapy (need for second-line chemotherapy, number of cycles/regimens, need for multiagent chemotherapy and time to hCG remission). Study participants will be allocated into 2 groups: North America (NA) and South America (SA). CHM clinical characteristics will be compared between groups using the test of Mann-Whitney, Chi-square or Fisher's exact test. The relationship of CHM initial treatment with binary and numeric outcomes will be analyzed using a multiple regression model, and Poisson-exponential models, respectively. (AU)