Outcomes
intra-abdominal bleeding
TUBAL ECTOPIC PREGNANCY, INTRA-ABDOMINAL BLEEDING
Treatment success for this analysis was defined as complete and uneventful resolution of tubal ectopic pregnancy (serum hCG <30 IU/l) following single-dose methotrexate treatment without additional treatment. Participants who required further treatment, medical (further methotrexate) or surgical (salpingectomy or salpingostomy by laparoscopy or laparotomy) were considered to have failed single-dose methotrexate treatment. The decision for surgical intervention was at the discretion of the responsible clinician and the rationale for this decision may have included worsening clinical symptoms, increasing serum hCG levels, clinical and/or laboratory and/or ultrasound signs of intra-abdominal bleeding, and participant’s request for surgery.Participants were categorized into treatment success or failure groups as defined above. We assessed the percentage change in serum hCG between Day 1 and Day 4, Day 1 and Day 7, and Day 4 and Day 7, where Day 1 was the date of methotrexate treatment.Longstanding variability is present in post-methotrexate serum hCG data resulting from inconsistency in defining the day of methotrexate administration as Day 0 or Day 1. Consequently, those who define the day of methotrexate as Day 0 will perform venepuncture for subsequent monitoring hCGs a day later than those who define the day of methotrexate as Day 1. To account for this variability, to reflect current clinical practice and to minimize data missingness, we extended our definition of Day 4 to include Days 3 and 4, of Day 7 to include Days 6 and 7 and of Days 4–7 to include Days 3–6. We adopted Day 1 as the day of methotrexate administration as our data showed clinicians most commonly used this definition based on the timing of subsequent blood sampling.