Table 2:
Author/Study location/Year | Ectopic pregnancy diagnostic criteria | Total patients per arm | Inclusion Criteria | Exclusion Criteria | Method of randomization | Definition of treatment success | Other outcomes studied | |
---|---|---|---|---|---|---|---|---|
Single versus Two dose | ||||||||
Song South Korea 2015 | bHCG, TVUS, physical exam, Medical history | 46 | 46 | 1. bHCG <15,000 mIU/mL 2. GS <4cm 3. Hemodynamically stable |
1. Heterotopic pregnancy or persistent tubal
pregnancy 2. +FHR 3. Suspected tubal rupture 4. Lab tests contraindicating MTX use |
Randomly permuted blocks with allocation concealment (1:1 ratio) | bHCG <5 mIU/mL | 1. Side effects 2. Length of follow-up 3. Rate of operation 4. Need for repeat doses 3. Cost of care received 4. Days of work/school missed 5. Treatment satisfaction |
Saadati Iran 2015 | bHCG,TVUS | 38 | 38 | 1. bHCG <15,000 mIU/mL 2. Hemodynamically stable |
1. Women with history of liver, kidney disease
or blood dyscrasia 2. Breastfeeding |
Block randomization with enclosed envelopes (1:1 ratio) | bHCG ≤ 200 mIU/mL | 1. Side effects 2. Length of follow-up 3. Rate of operation 4. Need for repeat doses |
Hamed Saudi Arabia 2012 | bHCG, TVUS, progesterone and D&C when abortion suspected | 78 | 79 | 1. bHCG of <15,000 mIU/mL 2. GS ≤4cm 3. Hemodynamically stable 4. Absence of FHR |
1. Women suspected of having non- adnexal
ectopic pregnancy 2. Suspected tubal rupture 3. Free fluid extending beyond Douglas pouch on TVUS 4. Lab tests contraindicating MTX use |
Computer generated random numbers table with opaque envelopes | bHCG <15 mIU/mL within 6 weeks without surgery or repeat dose | 1. Side effects 2. Length of follow-up 3. Rate of operation 4. Need for repeat doses |
Saleh Egypt 2016 | bHCG,TVUS | 80 | 80 | 1. bHCG ≤6000 mIU/mL 2. GS ≤4cm 3. Hemodynamically stable 4. Absence of FHR 5. <300mL hemoperitoneum on TVUS |
1. Hemodynamically unstable 2.Suspected tubal
rupture 2. Uncertain diagnosis 3. Falling bHCGs 4. Non-adnexal ectopic pregnancy 5. Lab tests contraindicating MTX use 6. Breastfeeding 7. Immunodeficiency or use of corticosteroids |
Computer generated randomization with sealed, opaque envelopes | bHCG <15 mIU/mL within 6 weeks without surgery or repeated dose | 1. Side-effects 2. Length of follow-up 3. Rate of operation 4. Need for repeat doses |
Single versus Multi-dose | ||||||||
Guvendang Guven Turkey 2010 | bHCG, TVUS, progesterone | 62 | 58 | 1. bHCG reaching plateau or increased by
≤50% in 48 hours 2. Adnexal mass ≤3.5cm 3. Hemodynamically stable |
1. Prior tubal surgery 2. Hemodynamically unstable 3. Hepatic or renal disease |
Computer assisted randomization with sealed envelopes | bHCG <5 mIU/mL | 1. Side-effects 2. Length of follow-up 3. Need for repeat doses |
Alleyassin Iran 2005 | bHCG,TVUS | 54 | 54 | 1. bHCG <15,000 mIU/mL 2. Adnexal mass <3.5cm 3. Hemodynamically stable 4. Absence of FHR |
None listed. | Computer generated block randomization with sealed envelopes | bHCG <15mIU/mL within 6 weeks | 1. Side-effects 2. Length of follow-up 3. Rate of operation 4. Need for repeat doses |
Tabatabaii iran 2012 | TVUS, Laparoscopic surgery | 35 | 35 | 1. bHCG <15,000 mIU/mL 2. Adnexal mass ≤4cm 3. Hemodynamically stable 4. Absence of FHR 5. Absence of bleeding in laparoscopic surgery or TVUS |
None listed. | Computer generated block randomization with sealed envelopes | bHCG <15 mIU/mL within 6 weeks | 1. Side-effects 2. Length of follow-up 3. Rate of operation 4. Need for repeat doses 5. Outcomes of subsequent pregnancies |