Optimal treatment for women with a persisting pregnancy of unknown location, a randomized controlled trial: The ACT-or-NOT trial.
Contemp Clin Trials
; 73: 145-151, 2018 10.
Article
en En
| MEDLINE
| ID: mdl-30243810
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 18â¯years or older from Reproductive Medicine Network clinics and additional interested sites, all patients will be followed for 2â¯years for fertility and patient satisfaction outcomes.INTERVENTIONS:
Randomization will be 111 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. MAINOUTCOME:
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
1_ASSA2030
Problema de salud:
1_doencas_nao_transmissiveis
Asunto principal:
Embarazo Ectópico
/
Abortivos no Esteroideos
/
Aborto Espontáneo
/
Metotrexato
/
Dilatación y Legrado Uterino
/
Espera Vigilante
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Guideline
Límite:
Female
/
Humans
/
Pregnancy
Idioma:
En
Revista:
Contemp Clin Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2018
Tipo del documento:
Article