Misunderstanding FIGO Recommendations On Prediction of PIH

Misunderstanding

Misunderstanding FIGO Recommendations On Prediction of PIH

Introduction:

           In its September 2019 issue International Journal of Gynaecology Obstetrics, FIGO recommendations on prediction of preeclampsia got published ¹. Since then thousands must have read it. It must have been referred to in many articles published in many journals by now. I am sure it must be helping many pregnant subjects throughout the world. However, what has driven me to write on this is one happening recently.

In February this year, I was invited as a guest faculty to a state conference in India. Looking at my interest, extensive work and my original publications on preeclampsia for decades now, a couple of beaming office-bearers of the host organization came to me. What they told me alarmed me instead of making me happy. They said; “Sir, following the FIGO recommendations on preeclampsia prediction, we have decided that in all pregnant subjects in our state we are now going to get biochemical markers done for prediction of preeclampsia”. This was along with the uterine artery colour Doppler pulsatility Index (UTPI). Having had read the recommendations more than once and knowing the Indian scenario very well, I was intrigued. Inviting them for a cup of tea, I requested them to tell me more. They shared with me their decision: All pregnant subjects in their state were henceforth to be subjected to Placental Growth Factor (PGF) or Pregnancy Associated Plasma Protein A (PAPP-A) for prediction of preeclampsia as I-trimester method of screening. I was amused. Their state is one of the largest states in India. Understandably therefore the absolute number of pregnant subjects at any given instance of time would be massive. I asked them; “Who will pay for these investigations?” The answer “The pregnant subject Sir”. One of them quickly picked up the discomfiture on my face. She hastened to add “Sir we are tying up with one or two laboratories who have a spread all throughout the state. This testing will be done there. We will make the facility available at a concessional rate”. Tea and cookies finished and this informal sit-down ended. But it left me with a flurry of thoughts.

Bearings of blindly following the recommendations in countries like India:

India is a huge country. Obstetricians serving the pregnant mothers are in many varied setups. Pregnant mothers are coming from different financial strata of the society. A big number is served by the Government run hospitals. Here predominantly the poor and lower middle-class clientele is served. Most of the in-house services are heavily subsidized by the government and many of them are absolutely free. However, in several of these hospitals some specialized tests are occasionally requested from private laboratories, if they are not done in-house. This includes the biochemical tests recommended by FIGO. Payment in such situations are done by the patient and her relatives. Though many times these tests are done at a concessional rate but that is not a rule. It all depends on the laboratory. A major set of pregnant subjects hail from this group.

Then there is a big group of pregnant subjects who take services of medium and small sized private hospitals in the country. That number is also massive. Added, there is a big clientele that takes services from some trust hospitals and similar setups. These subjects usually pay for all services from their own resources. In my city the laboratories charge anywhere between Rs. 1500 to Rs. 2000/- for performing these tests.

Then there is an emerging and sizable number of pregnant subjects who hail from affluent and well-resourced families. They prefer what are called “five-star hospitals”. There are quite a few of these now in India. In all of these, payments for any investigations requested comes from different sources. It includes the employee organizations of the pregnant subject or her spouse, sometimes insurance companies and of course her own personal resources. For this group of pregnant subjects, resources is not a problem and one test more is hardly a financial burden.

Having had largely understood the payment structure at hospitals and clinics in India, let us look at the implications of the FIGO recommendations and the result of misunderstanding these recommendations. As rightly mentioned on page 5 of the recommendations, pre-eclampsia is a multi-system disorder that typically affects 2%–5% of pregnant women. Globally, 76000 women and 500000 babies die each year from this disorder. The current recommendations on Page 6 endorse universal screening. By this it is meant that all pregnant women should be screened for preterm PE during early pregnancy by the first-trimester combined test with maternal risk factors and biomarkers as a one-step procedure. FIGO further qualifies this by stating that it encourages all countries and its member associations to adopt and promote strategies to ensure this. The best combined test as per the recommendations is one that includes maternal risk factors, measurements of mean arterial pressure (MAP), serum placental growth factor (PLGF), and uterine artery pulsatility index (UTPI).

The possible difficulties arising out of blindly adopting these recommendations in countries like India needs to be examined closely. In most hospitals and for most pregnant subjects in India this is not a ONE-STOP test. Biochemical tests and UTPI are not done in the same setup in most hospitals in India. The usual routine here is like this: The clinician examines the subject first in her clinic. Then if the clinic or hospital has an in-house colour Doppler facility then the pregnant subject can be subjected to it. If not, (and this is a reality in many clinics and hospitals) the pregnant subject will be referred to a sonologist who will perform the colour Doppler. Then after, the subject will go the pathology laboratory and there her blood will be drawn for biochemical markers. After a couple of days when all these reports will be ready the pregnant subject or her relative will go to each of these two points, collect the reports and go to their clinician to show the reports. And this holds true for a humongous number of pregnant subjects in India. So how can this be called a “one-stop” test?

These tests are backed by a very strong and near compulsory recommendation from FIGO. Many practitioners have already started requesting for both these tests – biochemical and UTPI and the pregnant subjects are paying.  I repeat the words of support from FIGO: “FIGO encourages all countries and its member associations to adopt and promote strategies to ensure this”. I find the wordings to some extent even intimidating.

I really wonder the huge financial outflow that has to occur from the personal resources of pregnant subjects in a country with a huge figure of pregnant gravida majority of whom are under-resourced. It can and must already be running into crores and crores of rupees. The committee that has finalized these recommendations has understood this difficulty. It has probably also understood that for a condition which has a prevalence of less than 10%, more than other 90% subjects have to pay for the tests. It is for this reason that there is a recommendation where biochemical tests and UTPI can be dispensed with. It is seen in the paragraph titled “Contingent screening”

Being fair to FIGO Recommendations:

Being Fair

I would like the readers to take cognizance of a small paragraph that this paper includes on page 6. I quote: “Contingent screening: Where resources are limited, routine screening for preterm PE by maternal factors and MAP in all pregnancies and reserving measurements of PLGF and UTPI for a subgroup of the population (selected on the basis of the risk derived from screening by maternal factors and MAP) can be considered”. Surely it has been made clear. The responsibility is now on the clinicians who want to implement the recommendation to be careful before blindly following. If at any instance it is found that recommending the biochemical markers and UTPI is going to be an unnecessary drain on the pregnant subject, we need to pause. FIGO recommendations do (albeit not very conspicuously) state that in such situations routine screening for preterm PE should be done by maternal factors and MAP in all pregnancies and reserving measurements of PLGF and UTPI for a subgroup of the population (selected on the basis of the risk derived from screening by maternal factors and MAP) be considered.

It is our responsibility to be balanced and not be carried away. We are misunderstanding the recommendations. Already so many of us have started sending our pregnant subjects for these tests blindly, citing FIGO recommendations. Have we understood the recommendations or misunderstood them?

Besides,  

1.  I have seen this with key office-bearers of obgyn fraternity organizations and
2.  When faculties are giving lectures on this topic through the net or as guest faculties during the CMEs of various fraternity organizations.

For the first, I feel we should not work overtime to make the so-called “concessional” services available to our members. We have already seen how really concessional these services can be. For the second, during our lectures and ensuing discussions we must make it clear what FIGO recommendations tell under contingent screening. Hiding or glossing over this section of recommendations will be unfair to the audience. We need to give a complete picture. I have seen faculties giving a balanced view when they do not get swayed or intimidated by FIGO and its recommendations. The recommendations have covered both aspects and let it be brought out clearly in the lectures and teachings.

There is one small point but relevant that needs to be looked at. On page 17 it is mentioned that the measurement of UTPI must be carried out by sonographers who have received the appropriate certificate of competence from the Fetal Medicine Foundation (FMF) (www.fetalmedicine.org). I am sure that this is applicable only for sonographers and not for obstetricians or sonologists with a postgraduate medical degree in their subjects. The doctors are already well trained and experienced in performing colour Doppler studies. This could have been clarified in the recommendations, to avoid a misunderstanding. 

The Future:

The Future

I also feel that these recommendations are an opportunity for research scientists to extend the utility of colour Doppler in screening for preeclampsia and identify some new indices and values. Their results should be as close as possible as or even better than the results with biochemical markers. Literature is replete with results of many such studies ^{2, 3, 4, 5, 6, 7, 8}. For this huge data will be needed from throughout the world. Also, the revision committee if and when formed will have to collate this data. Good quality data as emerged from FMF, must be available from other sources as well. This will serve as the middle-path. Many institutions and practitioners are now having and using colour Doppler scans. If robust results about some new indices and more detailed studies in Doppler emerge, they can give an added advantage of preeclampsia screening to the pregnant subjects at these hospitals and clinics. The plan is to have Doppler indices more than one, combined with maternal factors and MAP. This should be able to predict preeclampsia equally if not more efficiently. It can eliminate the need of biochemical markers. If that happens preeclampsia screening will genuinely be a “one-stop” testing.

References:

1.         Poon LC, Shennan A, Hyett JA, et al. The International Federation of Gynecology and Obstetrics (FIGO) initiative on pre-eclampsia: A pragmatic guide for first-trimester screening and prevention [published correction appears in Int J Gynaecol Obstet. 2019 Sep; 146(3):390-391]. Int J Gynaecol Obstet. 2019; 145 Suppl 1(Suppl 1):1–33. doi:10.1002/ijgo.12802

2.         Desai P, Desai M: Uterine artery pulsatility index less than 1.0 as an isolated marker in predicting low-risk subjects for preeclampsia. Int J Reprod Contraception Obstet Gynecol. 2016; 5(5): 1300-1303

3.         González-González NL, González-Dávila E, González Marrero L, Padrón E, Conde JR, Plasencia W. Value of placental volume and vascular flow indices as predictors of intrauterine growth retardation. Eur J Obstet Gynecol Reprod Biol. 2017; 212:13–19. doi:10.1016/j.ejogrb.2017.03.005

4.         Soongsatitanon A, Phupong V. First trimester 3D ultrasound placental volume for predicting preeclampsia and/or intrauterine growth restriction. J Obstet Gynaecol. 2019; 39(4):474–479. doi:10.1080/01443615.2018.1529152

5.         Vonck S, Staelens AS, Lanssens D, et al. Development of a biophysical screening model for gestational hypertensive diseases. J Biomed Sci. 2019;26(1):38. Published 2019 May 20. doi:10.1186/s12929-019-0530-0

6.         Desai P: Notch depth index alone and in combination with PI in prediction of preeclampsia at or before 32 weeks of pregnancy: Pregnancy Hypertension: 16, 2019, 11-15

7.         Sepúlveda-Martínez A, Rencoret G, Silva MC, et al. First trimester screening for preterm and term pre-eclampsia by maternal characteristics and biophysical markers in a low-risk population. J Obstet Gynaecol Res. 2019;45(1):104–112. doi:10.1111/jog.13809

8.         Leite JF, Lobo GAR, Nowak PM, Antunes IR, Araujo Júnior E, Pares DBDS. Prediction of preeclampsia in the first trimester of pregnancy using maternal characteristics, mean arterial pressure, and uterine artery Doppler data in a Brazilian population. Obstet Gynecol Sci. 2019;62(6):391–396. doi:10.5468/ogs.2019.62.6.391