Development of a single-visit protocol for the management of pregnancy of unknown location following in vitro fertilization: a retrospective study.

STUDY QUESTION: Can women with pregnancy of unknown location (PUL) following in vitro fertilization (IVF) be risk-stratified regarding the subsequent need for medical intervention, based on their demographic characteristics and the results of serum biochemistry at the initial visit? SUMMARY ANSWER: The ratio of serum hCG to number of days from conception (hCG/C) or the initial serum hCG level at ≥5 weeks' gestation could be used to estimate the risk of women presenting with PUL following IVF and needing medical intervention during their follow-up. WHAT IS KNOWN ALREADY: In women with uncertain conception dates presenting with PUL, a single serum hCG measurement cannot be used to predict the final pregnancy outcomes, thus, serial levels are mandatory to establish a correct diagnosis. Serum progesterone levels can help to risk-stratify women at their initial visit but are not accurate in those taking progesterone supplementation, such as women pregnant following IVF. STUDY DESIGN, SIZE, DURATION: This was a retrospective study carried out at two specialist early pregnancy assessment units between May 2008 and January 2021. A total of 224 women met the criteria for inclusion, but 14 women did not complete the follow-up and were excluded from the study. PARTICIPANTS/MATERIALS, SETTING, METHODS: We selected women who had an IVF pregnancy and presented with PUL at ≥5 weeks' gestation. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 30/210 (14.0%, 95% CI 9.9-19.8) women initially diagnosed with PUL required surgical intervention. The hCG/C was significantly higher in the group of women requiring an intervention compared to those who did not (P = 0.003), with an odds ratio of 3.65 (95% CI 1.49-8.89, P = 0.004). A hCG/C <4.0 was associated with a 1.9% risk of intervention, which accounted for 25.7% of the study population. A similar result was obtained by substituting hCG/C <4.0 with an initial hCG level <100 IU/l, which was associated with 2.0% risk of intervention, and accounted for 23.8% of the study population (P > 0.05). LIMITATIONS, REASONS FOR CAUTION: A limitation of our study is that it is retrospective in nature, and as such, we were reliant on existing data. WIDER IMPLICATIONS OF THE FINDINGS: A previous study in women with PUL after spontaneous conception found that a 2% intervention rate was considered low enough to eliminate the need for close follow-up and serial blood tests. Using the same 2% cut-off, a quarter of women with PUL after IVF could also avoid attending for further visits and investigations. STUDY FUNDING/COMPETING INTEREST(S): No external funding was required for this study. No conflicts of interest are required to be declared. TRIAL REGISTRATION NUMBER: N/A.

Predictive value of presence of amniotic sac without visible embryonic heartbeat in diagnosis of early embryonic demise.

OBJECTIVES: To assess the diagnostic value and impact on management of visualizing on ultrasound an amniotic sac without a live embryo (amniotic sac sign). We also examined the potential effect on the number of follow-up visits in early pregnancy units of incorporating this sign into current diagnostic algorithms. METHODS: This was a prospective cohort study of all pregnant women who attended a single specialist early pregnancy unit from July 2017 to November 2018 with symptoms of pain and/or bleeding, or with a history of ectopic pregnancy or miscarriage, at < 14 weeks' gestation. Detailed initial ultrasound findings were documented, including whether an amniotic sac was present in a normally sited intrauterine pregnancy with absence of a live embryo. Women were followed up until a conclusive diagnosis was made. RESULTS: The study included 6012 women who attended our unit with early pregnancy complications during the study period. A conclusive diagnosis was reached on the initial scan in 4221 (70.2%), whilst 1135 (18.9%) women had a pregnancy of uncertain viability and 656 (10.9%) had a pregnancy of unknown location (PUL). All women with a pregnancy of uncertain viability required follow-up ultrasound scans to differentiate between a live pregnancy and early embryonic demise. An amniotic sac in the absence of a live embryo was found in 174/1135 (15.3%) women with a pregnancy of uncertain viability at the initial ultrasound scan. The diagnosis of early embryonic demise was confirmed in all 134 of these women who attended their follow-up scans. The presence of an amniotic sac without a live embryo at the initial visit had a specificity of 100% (95% CI, 98.53-100.00%) and positive predictive value of 100% (95% CI, 97.2-100.0%) for the diagnosis of early pregnancy failure. A total of 1403/6012 (23.3%) women were asked to attend for a follow-up ultrasound scan to resolve diagnostic uncertainties, including 268/656 (40.9%) women with a PUL. The majority of follow-up scans needed to reach a conclusive diagnosis were in women with a pregnancy of uncertain viability (1135/1403 (80.9%)). By using the presence of the amniotic sac sign to diagnose early pregnancy failure at the first visit, the number of follow-up scans for pregnancies of uncertain viability would be reduced by 14.4%, which accounted for 11% of all follow-up scans during the study period. CONCLUSIONS: The finding on ultrasound of an amniotic sac without a live embryo (amniotic sac sign) is a reliable marker of early pregnancy failure and could reduce the number of follow-up scans by 11% in cases of diagnostic uncertainty. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Effect of morphological type of extrauterine ectopic pregnancy on accuracy of preoperative ultrasound diagnosis.

OBJECTIVES: To assess the overall accuracy of transvaginal ultrasound (TVS) for diagnosis of all types of extrauterine ectopic pregnancy (EUEP) in a large group of women who were managed surgically. We also aimed to assess the positive predictive value (PPV) of TVS for each of the different ultrasound morphological types of EUEP. METHODS: This was a retrospective observational study of all pregnant women who underwent emergency surgery following ultrasound diagnosis of EUEP at a single early pregnancy unit between January 2009 and December 2017. The preoperative TVS findings were recorded, including the exact location and morphological type (Type I-V; defined using ultrasound criteria) of EUEP. TVS findings were compared with operative and histological findings. The performance of ultrasound in diagnosing EUEP overall and according to morphological type was assessed, using visual confirmation of ectopic pregnancy at surgery as the reference standard. RESULTS: A total of 26 401 women presented with early-pregnancy complications during the study period, including 1241 (4.7%; 95% CI, 4.5-5.0%) women with a conclusive diagnosis of EUEP on TVS or a presumed diagnosis based on severe pain and significant hemoperitoneum. Surgery was performed in 721/1241 (58.1%; 95% CI, 55.3-60.8%) cases, of which 710 (98.5%; 95% CI, 97.6-99.4%) had a conclusive diagnosis of EUEP on preoperative TVS. The remaining 11 women had severe pain and significant hemoperitoneum and were managed surgically on clinical grounds as an emergency, without an ectopic pregnancy having been identified on ultrasound examination. At laparoscopy, the diagnosis of EUEP was confirmed in 706/710 (99.4%; 95% CI, 98.6-99.8%) women with a positive ultrasound diagnosis and in all 11 women with a presumed ultrasound diagnosis of EUEP. The PPV of preoperative ultrasound for the diagnosis of EUEP was 99.4% (95% CI, 98.6-99.8%) with sensitivity of 98.5% (95% CI, 97.3-99.1%). There was no statistically significant difference in the accuracy of preoperative ultrasound diagnosis between the five morphological types (P = 0.76). CONCLUSIONS: The accuracy of preoperative ultrasound for diagnosis of EUEP is high. The morphological type of EUEP on TVS had no significant effect on the accuracy of preoperative diagnosis. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.