Blob and Bagel sign on Ultrasound can be labelled as definitive for Ectopic Pregnancy

. blob sign of ectopic pregnancy.

Women with the Blob and Bagel ultrasound sign should be reclassified from having ‘probable’ ectopic pregnancy (EP) to ‘definitive’ EP and should be treated as such reports the result of a large retrospective cohort study published March 11, 2018, in Journal of Ultrasound in Obstetrics and Gynecology.

Ectopic Pregnancy is still the leading cause of first-trimester maternal deaths and constitutes 4% of all pregnancy-related deaths. The incidence of ectopic is highest in women undergoing In-Vitro Fertilization(IVF) and ranges from 4% to 11% of all pregnancies.

The broken arrow depicts the right ovary and the solid arrow shows ectopic pregnancy characterized by the ‘bagel sign’.

With the advent of high-resolution transvaginal ultrasound (TVS), more ectopic pregnancies are diagnosed at clinically early and hemodynamically stable stages that are amenable to various modes of management. In modern times TVS has replaced laparoscopy as the diagnostic tool of choice.

Barnhart et al have published a recent consensus statement of nomenclature, definitions, and outcome of pregnancy of unknown location (PUL) in Journal Fertility and Sterility. In which, research papers originating from the US diagnose EP based on findings of an extrauterine gestational sac with the visualization of a yolk sac or embryo, while literature from the UK and European countries diagnose EP based on finding of an extrauterine inhomogeneous mass (blob sign), or an extrauterine empty gestational sac (bagel sign). 

   

This study was undertaken with an aim to determine whether these ultrasound markers can be used to definitely predict EP, instead of just raising a probability of its presence. The study recruited 849 of 7490 consecutive women who attended the Early Pregnancy Unit (EPU) of the Nepean Hospital, Sydney, Australia over a period of 10 years.

At TVS, 240 of 849 women were diagnosed as probable EP, of which 174 (72.5%) exhibited the blob sign and 66 (27.5%) exhibited bagel sign. The rest 609 were labeled as PUL, of which 47 received a final diagnosis of EP (including 24 blob signs, 19 bagel signs and four gestational sacs with embryo/yolk sac.

Nearly 51% of patient with blob sign and 59% of patients with bagel sign underwent laparoscopic salpingectomy, and HPE proved the diagnosis in 97% of patients with blob sign and 96% of patients with bagel sign.

The sensitivity for the blob and bagel signs in the prediction of definite tubal EP was 89.8% and 83.3%, respectively, the specificity was 99.5% and 99.6%, PPV was 96.7% and 95.2% and NPV was 98.3% and 98.6%.

All the parameters were comparable to the corresponding parameters of the extrauterine gestational sac with yolk sac and/or embryo on TVS used in the prediction of definite tubal EP.

The authors concluded that Blob and bagel signs are the commonest presentation of tubal ectopic on TVS, and because of high PPV of >95%, it can be used for the definitive diagnosis of EP. Majority of women who present with EP during early pregnancy can have a definitive diagnosis with only standalone TVS, with laparoscopy being used as the treatment modality.

Abstract

Consensus statement

Media courtesy: Wikimedia Commons, research gate 

da Vinci robotic system saves fertility after reanastomosis following segmental resection of tubal ectopic pregnancy.

Clinical pearls:

• da Vinci-guided reanastomosis after segmental resection of tubal pregnancy is feasible for salvaging tubal patency and fertility in patients with absent or defective contralateral tubal function.

Patients with a single functional fallopian tube can be benefited by use of da Vinci robotic system for segmental resection and end to end reanastomosis of tubal ectopic pregnancy with higher chances of recovering the tubal patency after surgery.

The prevalence of ectopic pregnancy in women attending the emergency department with first trimester pain and bleeding is 6 to 16%.[i] The last CDC statistic quote the prevalence at 20 per 1000 pregnancies while the NHS shows that there are 11,000 ectopic pregnancies in U.K each year. [ii]

The occurrence of ectopic pregnancy in one tube increases the patients chance of getting ectopic in contralateral tube by 6-7-fold because both tube share similar pathology. Conventional option that are in frequent use includes methotrexate (MTX) therapy, salpingotomy, and milking of the ectopic implant. However, these options are not used very commonly due to delay in diagnosis of most ectopic pregnancies. They are diagnosed at a stage when rupture is imminent, thus limiting the use of options that can preserve the tube.

Researchers at the Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea reported results of a retrospective study of 17 patients who underwent segmental resections of tubal pregnancy followed by end-to-end reanastomosis over a period of 1.5 years. The paper was published in the October issue of Journal of Medicine.[iii]

The inclusion criteria for patients in the study are those diagnosed with tubal pregnancy actively seeking to conceive afterwards with stable vital signs, ages under 40 years, those with spontaneous or post-MTX rupture, presence of fetal heartbeat, and serum hCG levels initially over 5000 mIU/mL or elevated hCG levels despite MTX therapy. 

Exclusion criteria were pregnancy very near to corneal end or occupying fimbria, severe pain with tachycardia ,hypotension due to hemoperitoneum greater than 500 mL, size of ectopic pregnancy more than 5 cm and those patients suitable for MTX therapy ( without rupture and  preoperative serum hCG levels of less than 1500 mIU/mL)  as well as those with declining hCG level of more than 50% after 48 hours.

Out of 17 patients initially recruited, 14 patients underwent the procedure with 3 patients had to undergo salpingectomies due to intraoperative findings.

All surgeries were performed by team skilled in Robotic, Minimal Invasive Gynecological surgery as well as laparoscopic tubal anastomosis following tubal recanalization using the da Vinci robotic system (Intuitive Surgical, Mountain View, CA).[iv]

These patients were followed up for a period of 2 years for recovery of tubal patency, surgical complications, pregnancy and live births rates. 

Out of 14 patients who underwent surgery, only 11 were included in the final follow-up, as two patients were confirmed at surgery to have patent contralateral tube, and one did not desire immediate conception.

A HSG performed at 6 months’ follow-up showed 100% patency.

The cumulative pregnancy rate at 24 months was 63.64% (7/11) with no repeat tubal pregnancy. Follow-up beyond 24moths led to additional intrauterine pregnancies but they were not included in the study statistics.

The researchers stressed the need for additional future trials with larger number of patients to accumulate solid data on end to end reanastomosis after tubal resection surgery.

The authors concluded “tubal reanastomosis after segmental resection of tubal pregnancy using the da Vinci system is a feasible means of salvaging fallopian tube integrity and fertility in those with a single viable fallopian tube, demonstrating natural pregnancy rates compatible with that of conventional reanastomosis for tubal ligation.”

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[i] http://www.uptodate.com/contents/ectopic-pregnancy-incidence-risk-factors-and-pathology

[ii] http://www.nhs.uk/conditions/Ectopic-pregnancy/Pages/Introduction.aspx

[iii] http://journals.lww.com/md-journal/Fulltext/2016/10110/Robot_assisted_segmental_resection_of_tubal.5.aspx

[iv] http://www.davincisurgery.com/da-vinci-gynecology/

All caesarean section surgical techniques yield the same results: CORONIS Trial

The global C section rate is currently varying between 6% to 27% with an average of 19% of all births worldwide. In some countries the rate has reached all time high of 50% specially in Brazil, Iran, and Mexico, resulting in millions of women undergoing unnecessary surgery.

International health care community opines that a C-section rate of 10-15% is optimal, at which maternal and neonatal mortality is at its lowest, but anything in excess does not improve the statistics further.

Amazingly, no standard evidence based guidelines exist or best practice have been developed for this most commonly performed reproductive-age women surgery worldwide. The different in surgical techniques includes blunt versus sharp abdominal entry, single versus double layer closure, closure versus non-closure of the peritoneum, and polyglactin sutures over chromic catgut.

That’s what makes the results of CORONIS trail published in May, 2016 issue of The Lancet so important for healthcare providers all over the world. The trial was designed to assess whether any particular surgical technique was associated with better maternal and fetal outcome.

The CORONIS trial is a pragmatic international non-regular fractional, factorial, unmasked, randomized controlled trial (RCT)conducted at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. The study subjects consisted of women who were primi parous or with previous section planned to undergo C-section by transverse abdominal incision.

Women were randomly allotted to undergo one intervention from the each of the 5 assigned pairs of surgical techniques:

1. blunt versus sharp abdominal entry,
2. exteriorization of the uterus for repair versus intra-abdominal repair,
3. single versus double layer closure of the uterus,
4. closure versus non-closure of the peritoneum,
5. and chromic catgut versus polyglactin-910 for uterine repair.

The short term outcome was the composite of death, maternal infectious morbidity, further operative procedures, or blood transfusion (>1 unit) up to the 6-week follow-up visit.

The long term outcome included pelvic pain; deep dyspareunia; hysterectomy and outcomes of subsequent pregnancies.  13,153 (84%) of 15, 633 women were followed up for an average of 3.8 years.

No single technique was found superior to other in terms of maternal morbidity or long-term complications.  For blunt versus sharp abdominal entry, there was no evidence of a difference in the risk of abdominal hernias, for exteriorization of uterus for suturing, no difference was found in terms of increased infection, infertility or subsequent abdominal pregnancy. Increased incidence of maternal deaths, uterine rupture or dehiscence was no different when uterine incision was closed in single vs double layer.

The groups also did not show any difference in terms of uterine adhesions or pelvic adhesions when compared on closure versus non-closure of the peritoneum.

Only a slight difference was noted in terms of requiring blood transfusion in immediate post-operative period when comparing the use of polyglactin-910 vs chromic catgut. Those patients in whom chromic catgut was used required less blood transfusion but, long term follow up did not show any difference. The short term follow up results published in July, 2013 edition of The Lancet. 

The study has several limitations in terms of the participating centers being large tertiary care hospitals with highly skilled and experienced health care staff. The anticipated subsequent pregnancy rate in these cohort was also low (44% vs 80% expected). All women underwent elective C-section, resulting in a lower incidence of rupture uterus. A longer interpregnancy interval in the study participant also protected them against scar rupture.

The main strengths of the study were large sample size, stringent data collection, longer follow up and being conducted across many countries.

The study provides an important insight into epidemiological outcome of cesarean section, and concluding that no single method is superior over other. Most of the surgical techniques used during actual surgeries depends upon other considerations like surgeon’s personal choice, cost and time.

Dr. Marleen Temmerman from Aga Khan University, Nairobi, Kenya, and Ghent University, Ghent, Belgium, in an accompanying editorial conclude "For clinical practice, it is important to realize that all surgical techniques reported in this trial seem to be equally safe, which suggests that the rigorous use of the surgical techniques is more important than the technique as such. In view of the huge numbers of women undergoing this intervention, this report is important and long overdue.”

References:

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)30355-5/fulltext

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)60441-9/fulltext

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)00204-X/fulltext#sec1