Methotrexate or expectant management in women with an ectopic pregnancy or pregnancy of unknown location and low serum hCG concentrations? A randomized comparison

Mello, Norah M. van; Mol, Femke; Verhoeve, Harold R.; Wely, Madelon van; Adriaanse, Albert H.; Boss, Erik A.; Dijkman, A B; Bayram, Neriman; Emanuel, Mark Hans; Friederich, Jaap; Leeuw-Harmsen, Loes van der; Lips, J.P.; Kessel, M.A. van; Ankum, Willem M.; Veen, Fulco van der; Mol, Ben Willem J.; Hajenius, Petra J.

doi:10.1093/humrep/des373

Cited by 113 publications

(91 citation statements)

References 17 publications

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“…Yet, it is plausible that some of our PULs and final outcomes would have been considered differently in another setting. The definition of a PPUL is the least stringent outcome of PULs in the literature (Barnhart et al, 2011;Van Calster et al, 2013;Van Mello et al, 2013;Guha et al, 2014), and also in the present study. This limitation together with the study's retrospective nature emphasises the need of prospective studies.…”

Section: Discussionmentioning

confidence: 50%

“…PULs with a non-declining hCG and a non-confirmed location of the pregnancy that were confirmed neither by TVS nor by laparoscopy, and negative histological findings after uterine curettage, were defined as a persistent PUL (PPUL), as were those with plateauing hCG levels (<50% difference) between four consecutive measurements. As such, they were incorporated among the EPs in the analysis as in previous studies (Van Calster et al, 2013;Van Mello et al, 2013;Guha et al, 2014). Exclusion criteria were incomplete medical records, a second hCG value outside the limits of 24-72 h, a missing second hCG value or a first serum hCG value above 10 000 IU/l.…”

Section: Patient Selection and Data Collectionmentioning

confidence: 99%

See 1 more Smart Citation

Classification of pregnancies of unknown location according to four different hCG-based protocols

Fistouris

Bergh

2016

Hum. Reprod.

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STUDY QUESTION: How do four protocols based on serial human chorionic gonadotropin (hCG) measurements perform when classifying pregnancies of unknown location (PULs) as low or high risk of being an ectopic pregnancy (EP)?SUMMARY ANSWER: The use of cut-offs in hCG level changes published by NICE, and a logistic regression model, M4, correctly classify more PULs as high risk, compared with two other protocols.WHAT IS KNOWN ALREADY: A logistic regression model, M4, based on the mean of two consecutive hCG values and the hCG ratio (hCG 48 h/hCG 0 h) that classify PULs into low-and high-risk groups for triage purposes, identifies more EPs than a protocol using the cutoffs between a 13% decline and a 66% rise in hCG levels over 48 h. STUDY DESIGN, SIZE, DURATION:A retrospective comparative study of four different hCG-based protocols classifying PULs as low or high risk of being an EP was performed at a gynaecological emergency unit over 3 years. PARTICIPANTS/MATERIALS, SETTING, METHOD:We identified 915 women with a PUL. Initial transvaginal ultrasonography (TVS) findings categorised 187 of the PULs as probable intrauterine pregnancies (IUPs) and 16 as probable EPs. The rate of change in hCG levels over 48 h was calculated for each patient and subjected to three different hCG threshold intervals and a logistic regression model for outcome prediction. Each PUL was subsequently dichotomised to either low-risk (i.e. failed PUL/IUP) or high-risk (i.e. EP) classification, which allowed us to compare the diagnostic performance. In 'Protocol A', a PUL was classified as low risk if >13% hCG level decline or >66% hCG level rise was achieved; otherwise, the PUL was classified as high risk of being an EP. 'Protocol B' classified a PUL as low or high risk using cut-offs of 35-50% declining hCG levels and of 53% rising hCG levels. Similarly, 'Protocol C' used hCG level cut-offs published by NICE, 50% for declining hCG levels and 63% for rising hCG levels. Finally, if a logistic regression model 'Protocol M4' calculated a ≥5% risk of the PUL being an EP, it was classified as high risk, and otherwise the PUL was classified as low risk. When the time interval between two hCG measurements failed to meet an exact 48 h, extrapolation and interpolation of hCG values was made, using log linear transformation.MAIN RESULTS AND THE ROLE OF CHANCE: Protocols A, B, C and M4 classified 73, 66, 55 and 56% of PULs as low risk. The sensitivity for protocols A, B, C and M4 was 68% (95% confidence interval (CI) 61-75%), 81% (74-86%), 87% (82-92%) and 88% (83-93%), respectively. The specificity was 82% (80-85%), 77% (74-80%), 66% (62-69%) and 67% (63-70%) for protocols A, B, C and M4, respectively. All comparisons of sensitivity and specificity between the protocols were statistically significant except for protocol C versus protocol M4. In protocol C, 87% (66-97%) of misclassified EPs had rising hCG levels, compared with 19% (6-41%) for protocol M4 (P < 0.01). In a secondary analysis excluding probable IUPs and probable EPs, the results for 712 PULs ...

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Section: Discussionmentioning

confidence: 50%

Section: Patient Selection and Data Collectionmentioning

confidence: 99%

Classification of pregnancies of unknown location according to four different hCG-based protocols

Fistouris

Bergh

2016

Hum. Reprod.

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“…In the author's experience and in a study [12], there are cases that would have resolved on their own accord without any medical intervention. This Multicentre Randomised Control Trial, found no difference in primary treatment success rate of single systemic dose of methotrexate compared with expectant management, reporting the rate to be 76% and 59% respectively.…”

Section: ) No Intrauterine Pregnancy (As Confirmed On Ultrasound Scan)mentioning

confidence: 94%

Ectopic Pregnancy: Changing Trends in Management

Madu¹

2017

OGIJ

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“…However, the inclusion criteria and management protocols varied widely. In a randomized multicenter trial, van Mello et al [38] studied 73 patients with a visible ectopic pregnancy with a serum hCG level of ,1500 IU/L or a pregnancy of unknown location and a plateauing serum hCG level of ,2000 IU/L. They found that systemic MTX treatment did not have a larger treatment effect than expectant management.…”

Section: Expectant Managementmentioning

confidence: 99%

“…Yet, almost 80% of their patients had no conclusive evidence of an ectopic pregnancy (i.e., a pregnancy of unknown location). Furthermore, the power of their study was too small to evaluate predictors of treatment failure [38].…”

Section: Expectant Managementmentioning

confidence: 99%