Kurt T Barnhart1, Mary D Sammel2, Mary Stephenson3, Jared Robins4, Karl R Hansen5, Wahid A Youssef6, Nanette Santoro7, Esther Eisenberg8, Heping Zhang9. 1. Department of Obstetrics and Gynecology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States; Department of Biostatistics and Epidemiology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States. Electronic address: kbarnhart@obgyn.upenn.edu. 2. Department of Biostatistics and Epidemiology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States. 3. Department of Obstetrics and Gynecology, University of Illinois at Chicago, Chicago, IL, United States. 4. Division of Reproductive Endocrinology and Infertility, Northwestern University Feinberg School of Medicine, Chicago, IL, United States. 5. Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences, Oklahoma City, OK, United States. 6. Department of Obstetrics and Gynecology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States. 7. Department of Obstetrics and Gynecology, University of Colorado, Denver, United States. 8. Reproductive Sciences Branch, Eunice Kennedy Shriver NICHD, Rockville, MD, United States. 9. Department of Biostatistics, Yale University School of Public Health, New Haven, CT, United States.
Abstract
OBJECTIVE: Pregnancy of unknown location (PUL) is not a diagnosis but a transient state used to classify a woman when she has a positive pregnancy test without definitive evidence of an intra-uterine or extra-uterine pregnancy on transvaginal ultrasonography. Management of a persisting PUL varies substantially, including expectant or active management. Active management can include uterine cavity evacuation or systemic administration of methotrexate. To date, no consensus has been reached on whether either management strategy is superior or non-inferior to the other. DESIGN: Randomized controlled trial. SETTING:Academic medical centers. PATIENTS: We plan to randomize 276 persisting PUL-diagnosed women who are 18 years or older from Reproductive Medicine Network clinics and additional interested sites, all patients will be followed for 2 years for fertility and patient satisfaction outcomes. INTERVENTIONS: Randomization will be 1:1:1 ratio between expectant management, uterine evacuation and empiric use of methotrexate. After randomization to initial management plan, all patients will be followed by their clinicians until resolution of the PUL. The clinician will determine whether there is a change in management, based on clinical symptoms, and/or serial human chorionic gonadotropin (hCG) concentrations and/or additional ultrasonography. MAIN OUTCOME: The primary outcome measure in each of the 3 treatment arms is the uneventful clinical resolution of a persistent PUL without change from the initial management strategy. Secondary outcome measures include: number of ruptured ectopic pregnancies, number and type of re-interventions (additional methotrexate injections or surgical procedures), treatment complications, adverse events, number of visits, time to resolution, patient satisfaction, and future fertility. CONCLUSION: This multicenter randomized controlled trial will provide guidance for evidence-based management for women who have persisting pregnancy of unknown location.
RCT Entities:
OBJECTIVE: Pregnancy of unknown location (PUL) is not a diagnosis but a transient state used to classify a woman when she has a positive pregnancy test without definitive evidence of an intra-uterine or extra-uterine pregnancy on transvaginal ultrasonography. Management of a persisting PUL varies substantially, including expectant or active management. Active management can include uterine cavity evacuation or systemic administration of methotrexate. To date, no consensus has been reached on whether either management strategy is superior or non-inferior to the other. DESIGN: Randomized controlled trial. SETTING: Academic medical centers. PATIENTS: We plan to randomize 276 persisting PUL-diagnosed women who are 18 years or older from Reproductive Medicine Network clinics and additional interested sites, all patients will be followed for 2 years for fertility and patient satisfaction outcomes. INTERVENTIONS: Randomization will be 1:1:1 ratio between expectant management, uterine evacuation and empiric use of methotrexate. After randomization to initial management plan, all patients will be followed by their clinicians until resolution of the PUL. The clinician will determine whether there is a change in management, based on clinical symptoms, and/or serial humanchorionic gonadotropin (hCG) concentrations and/or additional ultrasonography. MAIN OUTCOME: The primary outcome measure in each of the 3 treatment arms is the uneventful clinical resolution of a persistent PUL without change from the initial management strategy. Secondary outcome measures include: number of ruptured ectopic pregnancies, number and type of re-interventions (additional methotrexate injections or surgical procedures), treatment complications, adverse events, number of visits, time to resolution, patient satisfaction, and future fertility. CONCLUSION: This multicenter randomized controlled trial will provide guidance for evidence-based management for women who have persisting pregnancy of unknown location.
Authors: Kurt Barnhart; Amy C Hummel; Mary D Sammel; Seema Menon; John Jain; Nahida Chakhtoura Journal: Fertil Steril Date: 2006-11-13 Impact factor: 7.329
Authors: Norah M van Mello; Femke Mol; Albert H Adriaanse; Erik A Boss; Antonius B Dijkman; Johannes Pr Doornbos; Mark Hans Emanuel; Jaap Friederich; Loes van der Leeuw-Harmsen; Jos P Lips; Evert Jp van Santbrink; Harold R Verhoeve; Harry Visser; Willem M Ankum; Fulco van der Veen; Ben W Mol; Petra J Hajenius Journal: BMC Womens Health Date: 2008-06-19 Impact factor: 2.809
Authors: Kurt T Barnhart; Karl R Hansen; Mary D Stephenson; Rebecca Usadi; Anne Z Steiner; Marcelle I Cedars; Emily S Jungheim; Kathleen M Hoeger; Stephen A Krawetz; Benjie Mills; Meredith Alston; Christos Coutifaris; Suneeta Senapati; Sarita Sonalkar; Michael P Diamond; Robert A Wild; Mitchell Rosen; Mary D Sammel; Nanette Santoro; Esther Eisenberg; Hao Huang; Heping Zhang Journal: JAMA Date: 2021-08-03 Impact factor: 56.272