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.

Amniotic sac reference interval in early pregnancy between 7 and 10 weeks' gestation.

OBJECTIVE: To establish a normal reference interval for amniotic sac measurements between 7 and 10 weeks of gestation and its relative size in relation to the gestational sac and the embryo. METHOD: This was a prospective, cross-sectional study of consecutive women presenting to UCLH Early Pregnancy Unit between August 2022 to June 2023. We included live, normally sited, singleton pregnancies with a normal 20-week anomaly scan. We collected 120 cases per gestational week totaling 360 cases. We performed an inter and intra-observer variability assessment in the measurement of mean ASD in 30 patients. Regression analyses were used to establish reference intervals for GSD to CRL, ASD to CRL, GSD to ASD and GSD:ASD ratio to CRL. The fitted regression line was calculated, along with a 90% prediction interval and the R2 value. RESULTS: There was good interobserver agreement (difference 0.007mm ± 1.105 (95%CI -2.160 to 2.174)) and good intra-observer agreement between Observer A (0.007 ± 1.105 (-2.160 to 2.174)) and Observer B (-0.014 ± 0.919 (-1.814 to 1.786)) in the measurement of mean ASD in 30 patients. Regression analyses showed a highly statistically significant association between each pair of values (all p-values <0.001). There were significant quadratic associations between mean GSD and CRL (R2 = 56%) and mean GSD and ASD (R2 = 60), significant cubic association between ASD and CRL (R2 = 90%) and significant quadratic association between GSD to ASD ratio and CRL (R2 = 68%). The regression equations were used to quantify the values of ASD and GSD to ASD ratios for a range of CRL values and gestational age in days. CONCLUSION: Our study has produced comprehensive reference intervals for amniotic sac size in early pregnancy which could be used in routine clinical practice. This article is protected by copyright. All rights reserved.

Prevalence of deep and ovarian endometriosis in women attending a general gynecology clinic: prospective cohort study.

OBJECTIVES: To assess using transvaginal ultrasound the prevalence of deep and ovarian endometriosis in premenopausal women attending a general gynecology clinic. We also investigated whether the presence of endometriosis was associated with various demographic factors and other pelvic abnormalities. METHODS: This was a prospective observational cohort study carried out between February 2019 and October 2020. Consecutive premenopausal women who attended our general gynecology clinic underwent pelvic ultrasound examination, performed by a single experienced operator. Pregnant women and those with a history of hysterectomy or oophorectomy were excluded. The primary outcome was the prevalence of deep and/or ovarian endometriosis. Secondary outcomes were the anatomical distribution of endometriotic lesions and the association of endometriosis with demographic characteristics and various pelvic abnormalities, which were analyzed using logistic regression and multivariable analysis. RESULTS: A total of 1026 women were included in the final study sample, of whom 194 (18.9% (95% CI, 16.6-21.4%)) had sonographic evidence of deep and/or ovarian endometriosis. Of the 194 women diagnosed with endometriosis, 106 (54.6% (95% CI, 47.4-61.8%)) were diagnosed with endometriotic nodules only, 26 (13.4% (95% CI, 9.0-19.0%)) with ovarian endometriomas only, and 62 (32.0% (95% CI, 25.5-39.0%)) women had evidence of both. There was a total of 348 endometriotic nodules in 168 women, located most frequently in the retrocervical area (166/348; 47.7% (95% CI, 42.4-53.1%)), uterosacral ligaments (96/348; 27.6% (95% CI, 23.0-32.6%)) and bowel (40/348; 11.5% (95% CI, 8.3-15.3%)). Multivariable analysis found significant positive associations between endometriosis and both adenomyosis (odds ratio (OR), 1.72 (95% CI, 1.10-2.69); P = 0.02) and pelvic adhesions (OR, 25.7 (95% CI, 16.7-39.3); P < 0.001), whilst higher parity (OR, 0.44 (95% CI, 0.24-0.81); P = 0.03) and history of Cesarean section (OR, 0.18 (95% CI, 0.06-0.52); P = 0.002) were associated with a lower occurrence of endometriosis. A total of 75/1026 women (7.3% (95% CI, 5.8-9.1%)) underwent laparoscopy within 6 months of pelvic ultrasound examination. There was very good agreement between ultrasound and surgical findings, with a kappa value of 0.84 (95% CI, 0.69-0.99). CONCLUSIONS: Deep and/or ovarian endometriosis was present in nearly one in five women attending a general gynecology clinic. There were significant positive associations with adenomyosis and pelvic adhesions and negative associations with higher parity and previous Cesarean section. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Reproductive outcome in 326 women with unicornuate uterus.

OBJECTIVES: To study the reproductive outcomes of women with a unicornuate uterus and compare them to those of women with no congenital uterine anomaly. METHODS: This was a single-center, retrospective cohort study. Cases were women aged at least 16 years who were diagnosed with a unicornuate uterus on transvaginal/transrectal ultrasound between January 2008 and September 2021. Controls were women with no congenital uterine anomaly matched 1:1 by age and body mass index. The primary outcome was live-birth rate. Secondary outcomes were pregnancy loss (miscarriage, ectopic pregnancy, termination of pregnancy), preterm delivery, mode of delivery and concomitant gynecological abnormalities (endometriosis, adenomyosis, fibroids). RESULTS: Included in the study were 326 cases and 326 controls. Women with a unicornuate uterus had a significantly lower live-birth rate (184/388 (47.4%) vs 229/396 (57.8%); P = 0.004) and higher rates of overall miscarriage (178/424 (42.0%) vs 155/465 (33.3%); adjusted odds ratio (aOR), 2.21 (95% CI, 1.42-3.42), P < 0.001), ectopic pregnancy (26/424 (6.1%) vs 11/465 (2.4%); aOR, 2.52 (95% CI, 1.22-5.22), P = 0.01), preterm delivery (45/184 (24.5%) vs 17/229 (7.4%); aOR, 3.04 (95% CI, 1.52-5.97), P = 0.001) and Cesarean delivery (116/184 (63.0%) vs 70/229 (30.6%); aOR, 2.54 (95% CI, 1.67-3.88), P < 0.001). Rudimentary-horn pregnancies accounted for 7/26 (26.9%) ectopic pregnancies in the study group. Women with a unicornuate uterus were more likely to have endometriosis (17.5% vs 10.7%; P = 0.018) and adenomyosis (26.7% vs 15.6%; P = 0.001), but were not more likely to have fibroids compared with controls. Women with a functional rudimentary horn were more likely to have pelvic endometriosis compared to those without (odds ratio, 2.4 (95% CI, 1.4-4.1), P = 0.002). CONCLUSIONS: Pregnant women with a unicornuate uterus should be classified as high risk. Removal of a functional rudimentary horn should be discussed with the patient to prevent a rudimentary-horn ectopic pregnancy. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

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.