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PREGNANCY IN ASSOCIATION WITHDIABETES MELLITUS

By UNA LEDINGHAM, M.D., F.R.C.P.

That the problems presented by the associationof pregnancy and diabetes mellitus is of absorbinginterest is proved by the recent spate of reviewsand reports on the subject. Despite this evidenceof continuing thoughtful study these problems re-main largely unsolved and, in defiance of con-siderable growth of knowledge, much remainsobscure.The facts are now well known, but the explana-

tion underlying them, together with the best meansof meeting them, is in dispute. These facts mustbear repetition for the sake of clarity.

Prior to the discovery of insulin the combina-tion was but rarely seen, on two accounts: fewyoung diabetic girls survived to childbearing age;and amenorrhoea and infertility of nutritional orendocrine origin afflicted those who did. Withthe successes achieved by insulin, and especiallysince long acting insulins became available, carry-ing their much improved degree of control, boththese influences have been abolished. Nowadays,though diabetic fertility is not up to normal, thesepregnancies account for something like one inthree hundred. That they are not more frequentdepends on the incidence of -diabetes mellitusfalling most heavily on women past childbearingage.Some time after insulin came into general use,

it became clear that pregnancy in diabetics ran adistinctive abnormal course. Later still the poolingof individual experiences led to widespread recog-nition of a specific problem, the outstandingfeatures being: for the mother, a liability to tox-aemia and to spontaneous premature delivery ofan apparently post-mature infant; for the foetusa tendency to die in utero in the last few weeks ofpregnancy or in the first two days of neonatal'lifeand in each case to be overweight. Together thesemade for a stormy pregna'ncy, a difficult labourand, most important, the persistence of a foetalmortality rate of about 50 per cent., little if anybetter than that of pre-insulin experience.The next advance was the recognition that

women destined to develop diabetes were subjectto identical obstetric and foetal accidents, and thatthe incidence and severity of these increased as

the date of delivery advanced towards the date ofonset of the disease. Thus, in the five years im-mediately antecedent to the diagnosis of diabetesthe foetal death rate equals that of overt diabetics,while in the twenty or more years preceding, it isvery much less, yet significantly more than thenormal.

Following the facts further, the influence of thepregnancy on the diabetes deserves first considera-tion. Two fundamental changes explain theinstability and tendency to the more serious com-plications often encountered. First, lowering ofthe renal threshold common to many pregnantwomen is not only much more common in dia-betics, but much more severe towards the end ofsuch a pregnancy. Thus results a glycosuria out ofall proportion to blood sugar levels. Second,there is a steady' deterioration of carbohydratetolerance throughout pregnancy, again mostobvious in the last three months and displayed asan increase in insulin needs not accounted for byany increase in carbohydrate intake. These to-gether explain why pregnancy will discover casesof latent diabetes, the aggravation of which, to-gether with disproportionate sugar leak conse-quent on the lowered threshold, results in glyco-suria obvious on routine testing. Further pointsdeserve mention: towards the end of pregnancythere may be a reversal and carbohydrate tolerancetends to improve; even more striking is the suddendrop in insulin requirements during and afterparturition, continuing for some days and mark-ing a definite recovery in the diabetic state. Finally,the patient's condition either reverts to her pre-pregnant state or is even better. It can be fairlysaid that pregnancy alone never accounts for anypermanent deterioration in the diabetes mellitusnor is there evidence that the rate of vascular de-generation is augmented.The precise reason for exacerbation of the dia-

betic state is not clear. Increased basal metabolicrate may be partially responsible, but since insulinrequirements rise before any corresponding risein this rate can be detected, other factors must beinvolved. A reasonable suggestion is an exagger-ation of anti-insulin effect, and it is tempting to

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ascribe this to excessive output of anterior pituitarydiabetogenic factor corresponding with the generaloveractivity of this gland during pregnancy.The late mitigation of the diabetic state is also

open to various explanations. Maternal hyper-glycaemia could stimulate over-secretion of foetalinsulin but such evidence as there is inclinesagainst this view, insulin not being known to passthe placental barrier. In any case the more strik-ing post-partum improvement remains unex-plained. More credible is the view that someharmful influence operating throughout pregnancyis removed with parturition. Anterior pituitaryfunction could be implicated again, as such aharmful influence could well be the diabetogenicfactor, the output of which, together with assoc-iated growth hormone, could be suddenly sup-pressed at term to make way for the requisite out-put of prolactin. No confirmation of this attractivetheory is forthcoming and it must remain guess-work.

In a known case the early and late months pro-vide most diabetic complications. Where anor-exia, capricious appetite or vomiting manifest inthe early months, insulin reactions may be bothfrequent and severe, and especially so when in-sulin dosage is based on urinary sugar estimations.In the later months ketosis is the main hazard.Foetal needs for carbohydrate increase, while atthe same time renal leakage may account for con-siderable waste. Unless these factors are allowedfor, the mother can be virtually deprived of carbo-hydrate, and fat is over metabolised with graveconsequences. During labour severe hypogly-caemia may again be prominent, contributed to byextra muscular exertion together with spontaneousimprovement in the diabetic state.

Lactosuria adds to the problems of diabeticcontrol in late pregnancy and the puerperium, andprovides another threat to satisfactory treatmentwhere insulin dosage is estimated against thedegree of reducing substances in the urine.The influence of diabetes on the pregnancy is a

more serious one and must be accepted as posi-tively harmful. In the early months this is hardlyperceptible, the abortion rate being little raisedabove the normal. Later on it becomes pro-gressively greater, showing in the exceptional rateof toxaemic complications to which these patientsare prone, figures quoted ranging from two tofifty times the normal. This diversity of figuresdepends on the wide scope of the meaning of theterm toxaemia, some including minor departuresfrom health, others discarding all but gross evi-dence in their diagnosis. Common estimates are25 to 30 per cent. of toxaemia sufficiently seriousto arouse concern. Appearing usually after thefifth month it follows the pattern of toxaemia in

non-diabetic pregnancies, the incidence andseverity rising steadily in the later months, reach-ing a maximum in the last four to six weeks.Hydramnios is a common early sign, presenting

as abdominal pain due to the tense and tenderuterus and, where substantial, detected by a sud-den rise in the position of the fundus. Smallerdegrees are difficult to diagnose. Causes areobscure: it may well represent early water andsalt retention; as with even the best balanced caseof diabetes the blood sugar is intermittentlyraised, high glucose content of the liquor maybe responsible. Oedema, often of sudden onset,hypertension and albuminuria together or sepa-rately are other familiar manifestations. Remem-bering that diabetics are independently subject tovascular degeneration, often demonstrable afterten years' duration, it is no surprise to know thatthe toxaemia is more frequent and more severe invictims of long standing disease. This connectionis stronger where known vascular changes exist inthe mother and is strongest where frank hyper-tension or - renal involvement complicate thematernal diabetes.

Unusual presentations are common, thoughearlier findings of 30 per cent. breech presentationhave not been repeated. The uterus is undulyirritable, may exhibit contractions throughoutpregnancy and uterine inertia may cause diffi-culties in labour.The most impressive evidence of specific abnor-

mality lies in the unusual pattern of natural de-livery; either spontaneous premature delivery atabout eight months, but recorded as early as thetwenty-eighth week, of an infant considerablylarger than its expected weight for its age; orstillbirth at term or after of a macerated giantfoetus. The placenta falls into line with thegeneral trend to irregularity and of large size, con-tains many small infarcts suggestive of prematureageing. Lactation is frequently inadequate fromendocrine or nutritional causes.

Rtmarkably, the maternal survival in spite of theadded chances of complication of both states ishighly satisfactory being often reported as iooper cent., occasional coma in the unrecognisedcase and severe hypertension accounting for thefew fatalities. This figure contrasts very favour-ably with the 25 per cent. mortality reported inthe pre-insulin era, together with a further 25 percent. of mothers lost in the two years followingchildbirth.The injurious influence of maternal diabetes on the

foetus is equally striking. Two characteristicsstand out: inherently poor viability, leading toan undue proportion of neonatal deaths; an in-clination to overweight.The first, affecting both premature and full term

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LEDINGHAM: Pregnancy in Association with Diabetes Mellitus

infants, is demonstrated by a weak cry at birth orafter, a sluggish attitude and, predominant in itsadverse implication, poor colour, tendency tocyanosis and difficult breathing. These last signsare dependent on pulmonary atelectasis and muchspeculation has been given as to the origin of this.Either blocking of the upper air passages withmucus, or depressed function of the under-developed brain, or both of these may be involved.Inhalation of amniotic fluid is another possibilityas excess has been found in the babies' stomachs.For one or more of these reasons, or for others yetunknown, death in the early neonatal period is acommonplace. Hypoglycaemia, once considereda potent factor, is now regarded as unimportant.The second characteristic, the large size of the

baby, is contributed to by oedema, by excess 'fatand by exceptional length of body and limbs.More remarkable is the general splanchnomegalyshown chiefly in the large size of the heart, liver andspleen. By contrast the skull and brain are smalland islands of erythropoiesis persist in liver andspleen similar to those found in erythroblastosisfoetalis.

Lastly, congenital defects add to the causes ofdeath, being found with unexpected frequency.Labour in any event is likely to be difficult and

to impair further the infant's chance of life. In-stability of the diabetes and tendency to toxaemiaof the mother, premature rupture of the mem-branes, difficulties attendant on hydramnios,abnormal presentation and delivery of a largebaby all share the blame.Many theories have been advanced in an attempt

to explain these matters but none wholly con-vincing. Thus, maternal hypoglycaemia has notbeen connected with foetal disaster and hypergly-caemia is equally exonerated since neither theseverity of the diabetes nor the degree of its controlbears any constant relationship to the generalpathology. Raised maternal blood sugar mayfavour the over-nutrition of the infant as displayedby excessive fat deposits, but alone could hardlyaccount for the large organs and long bones. Thatit is not the dominant factor in foetal overweightis proved by experience with pre-diabetics whoseinfants, as has already been said, behave as thoseof diabetics. Ketosis and coma must add to foetalinjury but such episodes are rare and becomingmore so under modern careful supervision.Further, many infants are known to have survivedmaternal ketosis while countless others have diedin its absence.Toxaemia subscribes more to the poor outlook,

and 46 per cent. of prematurity and of foetaldeaths both, have been recorded in its presence.It is still not the major fault. There is no truecorrelation between the incidence of toxaemia and

that of foetal morbidity. More convincing is thatthe foetal mortality of the toxaemic diabetic is atleast twice that expected of toxaemia alone.

Duration of the diabetes is one element de-finitely associated with a high rate of morbidity.Whether this adverse influence of long standingdisease is mediated through vascular degenerationor works independently is not settled.Age at onset plays some part, the young woman

whose disease arose in childhood being a no-toriously bad subject for a successful outcome, theolder woman with diabetes mellitus of recentorigin standing a much better chance of having alive baby.

Neither diabetic nor obstetrical influences thenseparately or jointly account for the knownfactors. Hence, when the theory of hormonalimbalance was put forward it was welcomed inthe hope that it would solve the problem. Itcame into the picture in the following manner.Workers in Boston found that in toxaemia ofpregnancy, at about the fifth month, unusuallyhigh levels of chorionic gonadotropin persisted inthe blood, together with correspondingly lowvalues of oestrogen and progestrone. Later, itwas found that the fall in sex hormones precededthe rise in chorionic gonadotropin, the latter beingregarded as a compensatory mechanism. Thishormonal imbalance preceded any clinical eri-dence of toxaemia by some weeks and it wasclaimed that redressing the balance, by admini-stration of the deficient sex hormones, could avertor reduce the toxaemia. Many patients concernedin the original work were diabetics and the prin-ciples were accordingly widely applied to thegeneral study of pregnancy in this disease.Ample confirmation was soon forthcoming ofthe presence of an unusual hormonal pattern inmany diabetics. The placenta being the siteof origin of the three hormones concerned,the findings were interpreted as representing dis-ordered placental function either idiopathic orresulting from vascular degeneration. Failure tosecrete sex hormones is the supposed primaryfault, compensatory high output of chorionicgonadotropin acting as the damaging agent inproduction of maternal and foetal pathology. Analternative view holds that deficient oestrogenlevels allow for uninhibited anterior pituitaryhyperfunction. A third theory considers the hor-monal imbalance to be but a side effect of someunknown fundamental happening itself responsiblefor maternal morbidity and foetal mortality. Ifthe first or second viewpoint is right, hormonetherapy could' be expected to be of value; thethird belief is incompatible with such a hope.The great champion of'the theory of hormonal

imbalance as being the major factor in the irregular

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pregnancies is White, who, working in Joslin'sworld famous clinic, claims that an abnormalcourse can be predicted on discovery of hormonalimbalance and that replacement therapy withstilboestrol and progestrone can substantially cor-rect this course. Using this method she claims afoetal survival rate of go per cent. with maternaltoxaemia reduced to 5 per cent. Here are otherrelevant figures concerning her 5I3 cases, thebiggest number yet observed: of 40 women foundto have normal hormonal levels there were 95 percent. live births, no spontaneous premature de-liveries and only two cases of serious toxaemia; of368 women with the demonstrable hormonal im-balance but treated with both sex hormones therewere go per cent. live births, eight cases of spon-taneous premature delivery and five cases of severetoxaemia; with the 96 women known to have asimilar hormonal imbalance but who were nottreated, the foetal survival rate was only 6o percent., while pre-eclampsia affected half the patientsand spontaneous premature delivery occurred ineighteen cases. In other hands this therapy hasnot yielded equally successful results.Though the existence of such a specific hor-

monal imbalance is now agreed, the clinical use-fulness of replacement therapy is not generallyaccepted. In fairness it should be said that manyfoetal death rates show a reduction in recent yearsto figures between io and 20 per cent. This im-provement could result through awareness of therisks, with resultant close attention to details ofboth diabetic control and threatened toxaemia, andto the current practice of timely termination ofpregnancy. On the other hand some credit couldbe given to the now widespread use of sex hor-mones. Disagreement as to the manner in whichthe hormones work has caused stilboestrol to beused alone (without progesterone) in the beliefthat inhibition of a previously over-active pituitarygland is the desired aim.Management is the concern of physician, ob-

stetrician and paediatrician alike and according totheir successful co-operation can good results beexpected. Complete agreement exists as to theessential aims. That is: good control of the dia-betes; and prevention or amelioration of waterretention and other evidences of toxaemia.

Changes in diet and insulin dosage are neces-sary. Carbohydrate intake should be increased toallow 30-50 grams for the foetus according to itsmaturity, with a margin for renal glycosuria whichif severe can account for 50-150 grams loss of car-bohydrate. Thus I 80-250 grams are usuallyneeded. Protein intake must likewise be raised toa minimum of one gram for one pound of bodyweight, two grams being a recommended allowancetowards term or where water retention is present.

Fat intake is estimated according to the mother'sweight, 20-30 pounds being a suitable total gain.Excessive gain is to be avoided at all costs, yet dia-betics are unusually prone to it and very low fatintake is sometimes indicated. Lean patients,provided they have no tendency to ketosis, maytake what fat they like. Full supplements ofvitamins should be given.

It cannot be stressed too firmly that insulindosage must be adjusted only with blood sugarguidance, in the face of a low renal threshold withits accompanying deceptive glycosuria. Not onlythe amount but the type of insulin may need to bechanged. Where a patient is accustomed to oneinjection of mixed soluble and protamine zinc, asubstitution of more frequent injections of solubleeven up to three or four doses daily may be useful,keeping the protamine zinc dose low. This appliesespecially where diminished appetite, vomiting orthreatened ketosis appear. Needless to say, allrefractory cases and those complicated by any butminor degrees of ketosis warrant hospital ad-mission.The late fall in insulin needs must be anticipated

and dosage cut without hesitation where fallingblood sugar values dictate. Where Caesareansecion or induction is planned, long acting typesare better avoided on the chosen day, such insulinas is required being given in soluble form aftercompletion of the operation.

Early recognition is one means of protectionagainst severe toxaemia, and each case should beassessed early on, age at onset, duration of diabetesmellitus, vascular status and previous obstetricalhistory being taken into account in estimating itslikelihood. White has done much to facilitatethis and has devised six categories, starting withlatent cases diagnosed only on an abnormalglucose tolerance curve, proceeding throughgrades determined by dates of onset and durationof diabetes, and ending up with cases of frankhypertension, calcification of pelvic arteries andrenal involvement. The trend towards maternalmorbidity and foetal mortality increases steadilythroughout these grades and the strictest controltherefore is exerted over patients in the later grades.Low salt diet and banning of sodium containingdrugs such as bicarbonate is applied where oedema,hydramnios or hypertension manifest even in smalldegree. Some go further and use these restric-tions in every case, either from the fifth month oreven throughout the pregnancy. Where any sub-stantial fluid retention develops ammonium chlo-ride in doses up to four grams daily can be triedin addition to complete bed rest. Mercurialdiuretics can be used to bring about further fluidloss if need be.The use of hormones and whether to use oestro-

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Vovember 1952 LEDINGHAM: Pregnancy in Association with Diabetes Mellitus 579

CLASSIFICATION OF OBSTETRICAL CASES AND BASIC PLAN OF DAILY HORMONAL TREATMENT (After White of Boston)

Classes A B C D E FDefinition .. .. Glucose Duration Duration Duration Calcified Nephritis

tolerance under IO. TO to I9. over 20. pelvictest. Onset Onset Onset less arteries.

over 20. l0 to I9. than 1O-Vascular o. Vascular o. years.

Vascular.-Calc. in legs,

retinitis.Per cent. of series .. 4 28 37 22 7 2

Hormone dosage of stilboestrol and proluton in milligrams of each, preferably by i.m. route

Week of Pregnancy. I.M. I.M. I.M. I.M. I.M.0-10 .. .. .. 0 5 5 Io 25 25

16-20 .. .. .. 0 5 5 10 25 2520-24 .. .. .. 0 10 10 I5 50 50

24-28 .. .. .. 0 I5 25 25 75 7528-32 .. .. .. 0 25 25 50 100 10032-onwards .. .. 0 50 50 75 125 125Probable Delivery Week 40 38 38 35 35 Viability.

Therapy regulation based upon:i. Weekly serum chorionic gonadotropin and urinary pregnandiol (glucoronidate) levels.2. Clinical evidence of disturbed water balance.

gen alone or together with progesterone is optional.Each must decide for himself after considerationof the conflicting views. It must be reaffirmedthat careful supervision and control being equal,the use of these has effected no greater improve-ment in either maternal or foetal abnormality inmany clinics of high repute, including that ofLawrence. As the theory, however, has beenshown to be virtually free from deleterious sideeffects either during or after the pregnancy, it maybe justifiable to use them in the long standing casewith definite vascular change carrying an admit-tedly poorer prognosis as well as where a pre-viously bad obstetrical history is obtained. De-tails of dosage of stilboestrol and progesterone aregiven in the accompanying table which includesWhite's methods of classification and her prefer-ence for date of delivery. Where stilboestrol isused alone the dose is graduated throughout toamount to i 6o mgm. daily in the final month.,

Interruption ofpregnancy before term is perhapsthe most profitable precautionary measure, apply-ing to all except the mildest cases and those fewwith a satisfactory obstetrical history. The choicelies between Caesarean section and surgical in-duction.With the recognition of the special risks to the

baby in the last four to six weeks of pregnancy itwas, and still is in this country, common practiceto carry out planned Caesarean section at 3 5-38weeks, usually at 36 weeks. Thereby excessiveprematurity and intra-uterine foetal deaths arelargely avoided. Two thirds of cases in manycentres are still handled in this way, the appro-

priate date being determined by consideration ofall aspects. Thus, long established disease, earlyage of onset and evidence of vascular. disease inthe mother, dictates the earlier date which is alsoindicated when there is a story of previous obstet-rical accidents or where uncontrollable toxaemiaor diabetic ketosis exist.

Induction is followed not only by an unpre-dictable delay in the onset of labour but labouritself is likely to be prolonged and difficult. Thebabies concerned stand lengthy labour extra-ordinarily badly and maternal diabetes is likely topresent a serious problem in control as bothvomiting and obstinate anorexia may supervene.It is not difficult to see why this method is oftendiscarded. There iq, however, an increasing re-action in favour of this procedure in the UnitedStates. Where premature delivery is decided uponthe pelvic route is preferred, artificial rupture ofthe membranes being carried out provided alwaysthat the state of the cervix is favourable. Caesareansection is then reserved for accepted obstetricalindications; postmaturity and strong evidence ofthe presence of a giant foetus; abnormal pre-sentation; or older primiparae and multiparaewith a poor past history. These conditions covera substantial number of cases.

Providing a good colour is maintained andcyanosis avoided, the choice of anaesthetic isopen, though deep general anaesthesia is patentlycontraindicated. The spinal route is often advocatedbut gas and oxygen with small amounts of cyclo-propane or trilene are used as often and as satis-factorily. In the interests of the foetus, no sedative

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580 POSTGRADUATE MEDICAL JOURNAL November 1952

such as morphine or a barbiturate is ever allowed,atropine being the sole premedication.Arguments against the use of any form of pre-

mature delivery are gaining strength and are basedon the increased risk to life that prematurity forceson a child already holding reduced chances of survi-val. Recently, attempts are being made to allow casesto proceed without interference and to terminate innatural births. Barns and Morgans adopting thispolicy estimate that any added foetal loss by deathin utero can be set against an improved neonatalsurvival rate. A much more extensive group ofcases must be watched before their conclusions arejustified and before the accepted method of earlyCaesarean section carrying certain improvementin foetal survival rates should be abandoned.To come to the right decisions as to whether to

terminate, the best time to choose, the rightmethod to use, each case should be completelyreviewed at 35 weeks, preferably in hospital.

It is abundantly clear from what has alreadybeen said that exceptional care must be affordedthe infant, irrespective of the manner of its birth.Gentle handling, especially of the fragile head,during delivery and after, warmth and a clear airway are the fundamentals. Upper air passagesmust be cleared with a mucus catheter and gastricsuction employed to avert inhalation of stomach

contents. Incubation with oxygen is needed forthree to five days, according to the maturity andresponse of the infant. No fluid is given in thefirst forty-eight hours during which oedema sub-sides and considerable weight loss results fromspontaneous diuresis. Hypoglycaemia not beingconsidered to contribute much to neonatal prob-lems, glucose should not be given. If the infantdoes well to the third day it stands a good chanceof survival. Later deaths are accounted for bycongenital defects or by birth injuries.In conclusion it must be emphasized that not all

diabetic women are subject to these hazards. Asmall number escape and undergo a normalpregnancy, terminating naturally in the deliveryof a healthy full-term child. One such experienceis a good portent for continued uneventful child-bearing. Unfortunately, no simple means has yetbeen devised to distinguish this fortunate groupfrom the unfortunate majority who will be exposedto the more eventful course. Even were hormonalimbalance accepted as the critical factor in theevolution of abnormality, the estimations requiredfor its detection are time consuming, difficult andexpensive and could not be applied on any widescale. It is better to regard all diabetic pregnanciesas potentially abnormal unless assurance from apreviously excellent obstetrical history is available.

CARCINOMA OF THEHEAD OF THE PANCREAS

By RODNEY SMITH, M.S., F.R.C.S.Surgeon, St. George's Hospital, London

Cancer of the pancreas has not long been con-sidered a possible, let alone a profitable, field forexcisional surgery. Until about twenty years agovery few attempts had been made to perform morethan a palliative operation, though a certain num-ber of local, conservative resections had also beencarried out and one radical pancreato-duodenec-tomy similar to the modern operatioft had beenattempted, though without success, by Codivillaas early as I898.The middle I930S saw a considerable revival of

interest in this difficult branch of surgery, andthe advent of vitamin K in I935, which so greatlyreduced the risk of operating upon a jaundicedpatient, naturally had a good deal to do with theprogress made. In this year (I935) Whipple andhis associates described their two-stage procedurefor the radical resection of a carcinoma of the

ampullary region and a great deal of the credit forreviving interest in pancreatectomy for cancer,must be given to these authors. In 1937Brunschwig successfully removed a carcinoma ofthe head of the pancreas using a similar two-stageprocedure.These islands and the Commonwealth did not

lack surgeons of skill and high courage interestedin the surgery of this region. Gordon-Taylor,James Walton and Illingworth are names that atonce spring to mind, while Victor Hurley of Mel-bourne had a success with resection by the retro-duodenal route. No one who heard Gordon-Taylor about this time will forget his enthusiasticinsistence that radical surgery must be attemptedon all suitable cases. His papers in 1942 andI943 referred to several successful cases of hisown, though his technique in those days was less

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