Proposed Updated Guidelines for Diagnosis of Pregnancy of Unknown Location (PUL)
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International Journal of Science and Healthcare Research Vol.5; Issue: 2; April-June 2020 Website: ijshr.com Short Communication ISSN: 2455-7587 Proposed Updated Guidelines for Diagnosis of Pregnancy of Unknown Location (PUL) Maged MN1, Mohamed MN2, Lamia H. Shehata3 1 Mazahmiya Hospital, Ministry of Health, Kingdom of Saudi Arabia, 2 Department of Obs/Gyn, King Fahd Hospital, Ministry of Health, Kingdom of Saudi Arabia, 3 Department of Surgery, Consultant Endoscopic Surgery, Department of Radiology, Care National Hospital, KSA Corresponding Author: Maged MN ABSTRACT combination of the two is between 6% and 16%. Early diagnosis of an extra-uterine pregnancy is important for safe and effective management. Epidemiology of Ectopic Pregnancy However, a pregnancy's location often cannot be Usually the oocyte and the sperm easily determined with abnormal implantations meet in the ampullary part of the fallopian or prior to 5-6 weeks’ gestation. Multiple testing strategies exist to diagnose an abnormal tube, and impregnation takes place. The pregnancy when location is unknown, but growing morula moves slowly toward the caution needs to be used to avoid a false uterus cavity while differentiating into the diagnosis. Medical treatment is optimal when an embryoblast and trophoblast. Implantation abnormal pregnancy is diagnosed early. Because in the uterine cavity usually takes place after most of these pregnancies are intrauterine, 6 or 7 days. additional testing to localize the pregnancy will allow the correct choice of therapy and avoids Etiology and Risk Factors unnecessary exposure to a toxic therapy should Theoretically, anything that impedes be reserved for patients with significant concern migration of the conceptus to the uterine for ectopic pregnancy, based on either risk cavity may predispose a woman to develop factors or clinical findings. Updating guidelines, to include MRI and new an ectopic gestation. These may be intrinsic biomarkers, is required to define early location anatomic defects in the tubal epithelium, of pregnancy (intrauterine or extra uterine) and hormonal factors that interfere with normal condition (healthy and unhealthy) pregnancy. transport of the conceptus, or pathologic conditions that affect normal tubal function. Keywords: (Ectopic pregnancy; MRI, The hormonal interference effects that Ultrasonography; Biomarkers; B-hCG; estrogen and progesterone show on the Progesterone). growth and the motility of the epithelial ciliae, and estrogen stimulates the growth INTRODUCTION and differentiation of the fallopian tube Implantation of the zygote outside including the generation of the epithelial the uterine cavity occurs in 2% of all ciliae. (1) pregnancies. The rate of ectopic pregnancies has increased from 0.5% in 1970 to 2% Diagnosis today. The prevalence of ectopic pregnancy Usually the earliest appearance of (EP) in all women presenting to an symptoms occurs in the sixth week after the emergency department with first-trimester last period. Patients with ectopic pregnancy bleeding, lower abdominal pain, or a can show all symptoms of a normal early International Journal of Science and Healthcare Research (www.ijshr.com) 447 Vol.5; Issue: 2; April-June 2020
Maged MN et.al. Proposed updated guidelines for diagnosis of pregnancy of unknown location (PUL) pregnancy, such as interruption of the almost all cases of suspected ectopic normal menstrual period, nausea, vomiting, pregnancy, ultrasound in combination with breast fullness, and fatigue. Typical clinical data and laboratory tests is sufficient symptoms of ectopic pregnancies are lower for making a correct diagnosis. Advantages abdominal pain and abnormal uterine include the ability of ultrasound to assess bleeding, ranging from spotting to severe for fetal heart activity to confirm the bleeding, Involuntary guarding and presence of an embryo and the ability to peritoneal signs are indicative of differentiate ectopic pregnancy from a intraperitoneal blood collection; there may corpus luteum by pressing down on the be tenderness on cervical motion. (2) ectopic pregnancy to separate it from an ovary. The most specific sonographic Serial Serum Human Chorionic feature of ectopic pregnancy is the presence Gonadotropin of an extra-uterine gestational sac (5) In a normally developing pregnancy, B-hCG starts secretion on days 5 to 8. A serum Role of MRI in ectopic pregnancy array detects levels as low as 5 mIU/mL, As previously described, ultrasound whereas the detection limit in urine is 20 to is the first-line imaging modality for 50 mIU/mL. obstetric imaging and diagnosis of ectopic The B-hCG levels double every 1.5 days in pregnancy. the first 5 weeks of a regular gestation. In addition to the aforementioned After 7 weeks, the sequence for double titers limitation of operator dependence, is 3.5 days. ultrasound is also limited by bowel gas In comparison, only 30% of ectopic interference, obesity or large body habitus, pregnancies show a normal B-hCG course, and small field of view. Another important In 70% of ectopic pregnancies, the B-hCG limitation relative to diagnosis of ectopic levels rise more slowly and reach a plateau pregnancy is ultrasound’s inability to or show a decrease in serum levels. An differentiate hemorrhage from other fluids. abnormal B-hCG pattern is highly As such, MRI plays an important suggestive of an ectopic gestation or a no role in the early diagnosis and management longer intact gestation. (3) of ectopic pregnancy. MRI is now increasingly being used in complicated Progesterone cases, in cases with unusually located Single serum P doses have been used ectopic pregnancy, and as a supplementary together with serum B-hCG doses in the problem-solving imaging modality, MRI follow-up of ectopic pregnancy. requires no specific patient preparation or Serum P levels are a satisfactory marker of premedication. Other advantages of MRI pregnancy viability, but they are unable to include no ionizing radiation, multi-planar predict the location of a pregnancy. P levels imaging, and excellent soft tissue contrast (6) below 5 ng/mL are associated with The major roles of MRI are to nonviable gestations, whereas levels above identify fresh hemorrhage, to accurately 20 ng/mL are correlated with viable localize the abnormal implantation site with intrauterine pregnancy, however, a superb spatial resolution, and to identify considerable proportion of EPs present with associated congenital uterine anomalies or P doses between 5 and 20 ng/mL, which Mullerian abnormalities. The fallopian limits its use in clinical practice to exclude tubes, round ligaments, and other adnexal the possibility of EPs (4) structures are easier to identify in the Role of ultrasound in ectopic pregnancy presence of pelvic fluid or hemorrhage. Ultrasound remains the first-line imaging Other important roles of MRI include modality for the evaluation of pregnant planning of the surgical approach in patients with abdominal or pelvic pain. In abdominal pregnancy, differentiation of International Journal of Science and Healthcare Research (www.ijshr.com) 448 Vol.5; Issue: 2; April-June 2020
Maged MN et.al. Proposed updated guidelines for diagnosis of pregnancy of unknown location (PUL) some forms of ectopic pregnancy from serum B-hCG level is 1800-2000 mIU/ml. incomplete abortion, and differentiation of In normal healthy pregnancies, the B-hCG ectopic pregnancy from other acute level should double about every two days, if conditions, such as ovarian torsion, pelvic no intrauterine pregnancy is detected, inflammatory disease, and acute knowledge of the B-hCG level is crucial. A appendicitis. (7) B-hCG level of 2000 long) non-protein coding genes able to mIU/ml (IRP), the intrauterine gestational recognize complementary messenger RNAs sac should be identified. (16) (mRNAs), acting as master gene regulators by repressing mRNA translation or by The discriminatory zone indicates the value mRNA degradation. (10) of serum B-hCG above which an Previous studies demonstrated dysregulation intrauterine gestational sac should be visible of miRNA expressions in early embryonic on ultrasound. tissues and in the fallopian tube of women Most services consider a with EP, including Lin28b, let-7, miR-132, discriminatory zone between 1,500 and miR-145, miR-149, miR-182, miR-196, 2,000/2,500 mIU/mL of B-hCG while using miR-223, miR-424, and miR-451 (11,12,13) TVUS. (17) When the B-hCG value is above Circulating miR-323-3p has a high the discriminatory zone and no intrauterine sensitivity for ectopic pregnancy diagnosis, gestation is visible on TVUS, an EP should when used as a single marker (14) miR-873 be suspected; however, it is possible to have could be a valuable noninvasive and stable a viable intrauterine pregnancy, even if the biomarker for the early detection of EP (15) ultrasound does not show an IUP, and the B-hCG value is above the discriminatory DISCUSSION zone. Early diagnosis of ectopic pregnancy Several studies have documented the is essential, because ruptured ectopic appearance of embryos with cardiac activity pregnancy in a hemodynamically unstable in the follow-up of pregnancies where the patient requires urgent or emergent surgical gestational sac was not visible on TVUS intervention. with B-hCG values above 2,000 mIU/Ml. (18) Laboratory investigations in ectopic pregnancy with negative serum B-hCG level Serum P doses are useful in cases of virtually exclude the possibility of live PUL (pregnancy of unknown location) to pregnancy. identify patients with PULF (pregnancy of Serum B-hCG is secreted by the unknown location failure) and thereby placenta and can be detected in the blood minimize the examinations and days of stream about 9 days after conception or follow-up because they are considered low approximately 3 weeks after last menstrual risk, regardless of the location of the period (LMP). A gestational sac should be pregnancy. P
Maged MN et.al. Proposed updated guidelines for diagnosis of pregnancy of unknown location (PUL) positive predictive value for Pregnancy As such, MRI plays an important failure of 98.2%. (19) role in the early diagnosis and management Concentration of serum miR-323-3p of ectopic pregnancy. was higher, in women with EP. Among MRI is now increasingly being used in these miRNAs, circulating miR-323-3p has complicated cases, in cases with unusually the highest sensitivity when used as a single located ectopic pregnancy, marker. Furthermore, the combined B-hCG, On MR imaging, the features of tubal progesterone, and miR-323-3p show even pregnancy include: higher sensitivity and specificity when Sac-like cystic tubal lesion with a thick compared to each use alone, suggesting that wall (24) that is located within the miR-323-3p might be a useful biomarker to fallopian tube. The wall shows high improve the diagnosis of EP. (20) signal intensity on T2-weighted MR As a single marker, miR-873 has a high images, and hemorrhage adjacent to the sensitivity at 61.76 % (at a fixed specificity wall is frequently observed of 90%), suggesting its potential as a Hemato-salpinx with tubal dilatation biomarker for the early detection of EP. (15) occurs after implantation of the embryo Ultrasonography is the best into the epithelium of the fallopian tube. examination method for identifying the This process can lead to bleeding and location of an early pregnancy. TVUS subsequent hemato-salpinx. (25) It identified the location of the pregnancy in typically demonstrates as dilated 91.3% of pregnant women. Of these fallopian tube with high signal intensity women, 89.6% were diagnosed with fluid on T1-weighted MR images. intrauterine pregnancies (IUPs), 1.7% were Hemorrhagic complex adnexal mass that diagnosed with ectopic pregnancies (EPs), is separate from the ovary when non- and 8.7% were diagnosed with PUL. (21) contrast images are equivocal, post- One great concern of PULs is that contrast images may be helpful. they are cases of ectopic pregnancy whose Findings on post-gadolinium diagnosis might be postponed. TVUS is able administration images include tree-like solid to identify an EP with a sensitivity ranging enhancement that represents feto-placental from 87% to 94% and a specificity ranging tissue within complex adnexal mass, from 94% to 99% when multiple exams are peripheral enhancement of gestational cystic performed. mass that corresponds with the sonographic With a single examination, TVUS identifies tubal ring sign, and tubal wall enhancement EPs with 73.9% sensitivity and 98.3% that is thought to reflect increased specificity. (22) vascularity in the tubal wall. Post- Regarding PULs, a common mistake gadolinium images may facilitate more is to perform TVUS alone. The adnexa accurate detection of ruptured tubal might be located in a higher region, and pregnancy. only a pelvic abdominal ultrasound enables Although no specific MRI findings visualization and identification via a relating to tubal rupture have been fully suggestive image to diagnose EP. (23) described, disruption of tubal wall In addition to the aforementioned enhancement may be seen in ruptured tubal limitation of operator dependence, pregnancy, and the demonstration of acute ultrasound is also limited by bowel gas or recent hematoma showing distinct low interference, obesity or large body habitus, signal intensity on T2 weighted images and small field of view. Another important located outside the enhancing implantation limitation relative to diagnosis of ectopic site may suggest tubal rupture in pregnancy is ultrasound’s inability to symptomatic patients. (26) differentiate hemorrhage from other fluids. Interstitial pregnancy occurs when the embryonic tissue implants in the International Journal of Science and Healthcare Research (www.ijshr.com) 450 Vol.5; Issue: 2; April-June 2020
Maged MN et.al. Proposed updated guidelines for diagnosis of pregnancy of unknown location (PUL) intramural or interstitial portion of the fundus at one end and the cervical canal at fallopian tube, which is eccentrically located the other. (29) in the fundal region of the uterus. This Ovarian pregnancy is a rare form of location allows for painless growth, and the ectopic pregnancy, being found in only 3% increased distensibility of this region of all ectopic pregnancies. A gestational facilitates a gestation period that can last as sac-like structure within the ovary that long as 16 weeks. frequently contains acute hemorrhage with Given the proximity of this type of obvious low signal intensity on T2-weighted pregnancy to the uterine artery, rupture can image and normal fallopian tubes are the cause life-threatening uncontrolled massive suggestive imaging features of ovarian intraperitoneal bleeding. Early diagnosis of pregnancy on MRI (8) interstitial pregnancy is sometimes difficult Cesarean scar pregnancy, MRI, to make on ultrasound since it can be however, is able to demonstrate gestational misinterpreted as normal intrauterine sac localization and its relationship with pregnancy with eccentric location. (27) adjacent organs, and it can assess for Angular pregnancy refers to myometrial invasion and bladder implantation of the embryo in the involvement. endometrium of the lateral edge of the A key MRI finding is the absence or uterus, medial to the utero-tubal junction. thinning of myometrium between the Angular pregnancy can be confused with bladder wall and the gestational sac on T2- both normal pregnancy and interstitial weighted imaging. Other imaging findings pregnancy. to support a diagnosis of cesarean scar Distinction between angular pregnancy are an empty uterus and cervical pregnancy and interstitial pregnancy can be canal, and gestational sac formation in the difficult, but it is important because angular anterior part of the lower uterine segment. (30) pregnancy can be carried to term. Angular and interstitial pregnancies may both appear Abdominal pregnancy is categorized as a heterogeneous mass of gestational sac into primary and secondary types. Primary with intermediate to high signal intensity on abdominal pregnancy is defined as T2-weighted imaging and surrounded by pregnancy in which the embryo is directly myometrium. implanted in the peritoneal cavity, and this However, if there is an intact type is extremely rare. Secondary abdominal junctional zone between the mass and pregnancy, the more common type of endometrium, and the mass is lateral to the abdominal pregnancy, is defined as tubal round ligament, then these findings are pregnancy that ruptured and that then re- suggestive of an interstitial pregnancy. (28) implanted in the abdomen. Blood supply Incidence of cervical pregnancy is can be recruited from the omentum and less than 1% of all ectopic pregnancies. abdominal organs. Early abdominal Diagnosis can be made when the gestational pregnancy may mimic tubal pregnancy if sac is discovered within the cervix. MRI is located in the pelvic cavity. MRI may be helpful for making a diagnosis. MRI helpful to establish diagnosis. findings include, a heterogeneous mixed On MR imaging, a gestational sac signal intensity lobulated mass that associated with hematoma may be detected represents the gestational sac occupying the in the pouch of Douglas. There is an cervix, enlarged cervical canal, and normal observable lack of myometrium surrounding endometrial stripe. the gestational sac. A cervical pregnancy may result in MRI is better than sonography for an hourglass-shaped or figure eight-shaped clarifying anatomic relationship with uterus that is formed by a distended uterine surrounding structures, vascular supply, oligohydramnios, placental site, and unusual International Journal of Science and Healthcare Research (www.ijshr.com) 451 Vol.5; Issue: 2; April-June 2020
Maged MN et.al. Proposed updated guidelines for diagnosis of pregnancy of unknown location (PUL) fetal lie, and this can assist in preoperative Advise women to return if there are new planning and prediction of possible symptoms or if existing symptoms worsen, complications during surgical treatment. (31) and for a woman with an increase in serum The benefits of MRI in abdominal B-hCG levels greater than 63% after 48 pregnancy also include detection of unusual hours, inform her that she is likely to have a shape of gestational sac, location of developing intrauterine pregnancy (although implantation site, and presence of flattened the possibility of an ectopic pregnancy placenta. MRI also provides details about cannot be excluded) and offer her a potential vascular connections and placental transvaginal ultrasound scan to determine adherence to surrounding structures. A the location of the pregnancy between 7 and rounded gestational sac and crescentic 14 days later. Consider an earlier scan for placenta are more likely to be observed in women with a serum B-hCG level greater intrauterine and tubal pregnancy. than or equal to 1500 IU/litre. (33) Abdominal pregnancy can present at advanced gestational age, up to and ACOG recommendations including full term. Associated Here may be a role for expectant complications include massive hemorrhage, management of ectopic pregnancy in T disseminated intravascular coagulation, gut specific circumstances. Candidates for obstruction, and fistula formation caused by successful expectant management of ectopic fetal bones protruding through the thin pregnancy should be asymptomatic; should amniotic sac. (32) have objective evidence of resolution All guidelines for pregnancy of (generally, manifested by a plateau or unknown origin recommended conservative decrease in hCG levels); and must be period 7-14 days, with repeated B-hCG counseled and willing to accept the potential levels and TVS examinations. risks, which include tubal rupture, hemorrhage, and emergency surgery. If the RCOG GUIDELINES initial hCG level is less than 200 mIU/mL, Women with a pregnancy of 88% of patients will experience spontaneous unknown location could have an ectopic resolution; lower spontaneous resolution pregnancy until the location is determined. rates can be anticipated with higher hCG Do not use serum B-hCG measurements to levels (34) determine the location of the pregnancy, and Irish guidelines recommendations place more importance on clinical Extended observation of women symptoms than on serum B-hCG results, who have an uncertain prognosis in early and review the woman's condition if any of pregnancy has shown that many EPs resolve her symptoms change, regardless of spontaneously. Expectant management is an previous results and assessments. Use serum option in selected women with probable EP B-hCG measurements only for assessing provided they have minimal symptoms and trophoblastic proliferation to help to are compliant with follow-up. In the determine subsequent management, and presence of a non homogenous adnexal take 2 serum B-hCG measurements as near mass, it has been shown that expectant as possible to 48 hours apart (but no earlier) management may have a success rate of to determine subsequent management of a over 80% provided that the initial B-hCG is pregnancy of unknown location. less than 1,000 IU/L and falling by at least Regardless of serum B-hCG levels, 13% over 48 hours. give women with a pregnancy of unknown Continuing outpatient observation is location written information about what to appropriate if the woman is clinically stable. do if they experience any new or worsening She should be given written information symptoms, including details about how to explaining her condition and the possible access emergency care 24 hours a day. complications of EP. She should understand International Journal of Science and Healthcare Research (www.ijshr.com) 452 Vol.5; Issue: 2; April-June 2020
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