EXPERIENCES WITH A POORLY EFFECTIVE ORALCONTRACEPTIVE IN AN INDIAN VILLAGE*

R. N. BASUAll-India Institute of Hygiene

RESUMEN

Un contraceptivo oral, desarrollado conbase en un tipo deguisante y conocido como debajaefecti­vidad, fue administrado a un grupo de aldeanos de Singur, India. Quienes hacian el experimentorazonaron que aun cuando la efectividad de la pildoraseriabaja, si un porcentaje alto de parejas lausaban, la tasa de nacimiento podiadisminuir al menosen forma substancial. Este trabajo informasobre los resultados de la ejecucion de ese programa. La reaccion de los aldeanos fue primero muyfavorable. La idea de disponerde un contraceptivo que podiatomarse por la boca [ue muy atrayentey 40 por ciento de las mujeres en edades reproductivas aceptaron participar voluntariamente en elprograma. Muchasde las queno participaron eranmujeresque todavia no haMan dado a luz 0 tenidoun hijo. La noticiade quelas mujeresresultaban en cinta a pesarde tomarel medicamento empezo acircular al meso La actitud deentusiasmo empezo a convertirse en insatisfaccion y desconfianza en lapildora. Muchasde las mujeresqueresultaron embarazadas culparon al gobierno y demandaron quese pusieraierminoa su embarazo. Todas las voluntarias, conexcepcioti de una fraccion pequeiui, de­jaron devenir a la clinica a recibir el medicamento y el personal de campo del programa se vio obli­gada a llevarlo a lasfamilias paraadministrlirselo, confrecuencia despuee derecurrir a la persuasion.Al final delestudio 50 por ciento de las mujereshaMan resultado embarazadas y 27 por ciento hobiarehusado continuar usando el medicamento, particularmente debido a desconfianza. Asi, menos dela cuarta partede las voluntarias continuaron hastael fin, a pesar de la labor mensualde persuasiony reparto delmedicamento a la casaconatencion medicaen caso de cualquier sintomadeefectos late­rales. Esta experiencia revela quela idea de un contraceptivo orales muy atrayente; tal nivel alto deentusiasmo no se obtuvo con respecto a ninguno delos otros metodos anticoncepcionalcs que tambien.estaban disponibles. Pero la experiencia tambien demostro que si se espera que un programa anti­concepcional sea aceptado los metodos administrados deben ser efectivos. En la siiuacion. de la aldealas noticiasde los[rocasos delmetodo circulan rlipidamente y pueden crear una desconfianza generalen la pildora. Esta experiencia tambien demuestra el papelimportante de los hombres parainfiuir enla actitudde sus eeposas, Aun el metodo anticoncepcional mlis simple debe ser introducido medianteeducaeum. y campana de motivaciOn; sin el consentimiento y cooperacioti de los esposoe cualquierprograma anticoncepcional fracasard.

I. INTRODUCTION

This note will describe some interestingsidelights on how a rural community inIndia reacted when an oral contraceptiveeasy to use but of relatively low effective­ness was popularised among the people.

Seventy-eight percent of the Indianpeople live in villages. Men are mostlyengaged in agricultural work (62 percent)and women are busy in household workin the rural area. Most of the women areilliterate (82.4 percent of the wives), andonly a few men (23.2 percent of husbands)have received their primary education.The people use community tube-wells or

* The study was conducted under the super­vision and guidance of Dr. (Mrs.) M. Sen, Direc­tor, and Dr. K. K. Mathen, Professor of Statistics,All-India Institute of Hygiene and Public Health,Calcutta.

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sanitary wells for their water supply. Inmost of the houses, the couples sleep withtheir children in the same room. Whenhealth workers talked on family planningto the villagers, there was no systematicopposition. They liked the idea of smallfamily size and desired a simple method,especially an oral pill. It was felt thatthe older methods cannot qualify for uni­versal acceptance of the poor and ig­norant people. Experiences of the familyplanning workers in different parts ofIndia showed that developing an oralcontraceptive, which can be easily ad­ministered has great practical significancein the country, where the vast majorityof population is poorly motivated to fami­ly planning. It must be cheap and aseasily available as aspirin or quinine.

IV. RESPONSE TO THE PROGRAMME

A supporting programme to enlist thecooperation of men even though the drugwas to be taken by women was foundnecessary. Local village committees werecontacted and the programme was ex­plained to them. The leader's consent wasenlisted before initiating the programme.Enrollment of the women for the trial waspreceded by a preliminary contact survey.All women in the village belonging toreproductive ages were contacted indi­vidually and were informed about theavailability of the oral pill. During thefirst contact, 57 percent of the marriedwomen expressed their willingness to takethe drug. They were also told that there

Experiences with a Poorly Effective OralContraceptive in an Indian Village 107

11. STUDY ON ORAL PILL the Calcutta Study. This wasdone becauseDr. S. N. Sanyal [1] and his co-workers it was always easier to remember the days

of a week than the dates of a monthfor theof Calcutta, claimed that Metaxylohydro- village women. If a woman starts menstrua-quinone, the active principle of the field tion on Monday, Monday after a fortnightpea (Pisum Sativum Linn), if taken orally will be the first scheduled day and the Mon-by a woman has an antifertility effect. day following will be the next one.Clinical studies at the All-India Institute 2. It was important to note that the womenof Hygiene and Public Health, Calcutta enrolled for trial were under close observe-found the drug to be poorly effective but tion and that in particular the drug shouldnon-toxic and harmless after continuous be taken by the women in the presence ofuse. There was no deleterious effect on the the field staff connected with the scheme.

3. Continuous data on the onset of menstrua-child born in cases of failure. The drug tion were requiredboth for working out thehas to be taken twice in a month, one specific dates on which the drug should betablet on the 16th day and another on administered and for getting an early indi-the 21st day from the onset date of men- cation of a possible pregnancy.struation. These days were chosen with the 4. In case of the women whowere in the stageexpectation of preventing the lining of of lactation amenorrhoea, the drug wasad-the uterus from being prepared for the ministered every 15thday till they resumednidation of the fertilized ovum. It was menstruation.thought that, as the drug was very easy 5. Women who were experiencing delayedto use, there would be high acceptability. menstruation were closely observed and

h were asked to attend the clinic. The drugThe hig use rate would balance the low was stopped whenmedical examination in-effectiveness of the drug in achieving the dicated that the womanwas pregnant.reduction of community birth rates. There 6. In case the women failed to come to themay be individual failures but use by a centre (clinic or distribution centre) on thelarge number of people would produce scheduled dates, they werevisitedat homemass benefit. The relationship between on the next day. Efforts were made to ad-clinic effectiveness and acceptability is minister the drug within 24 hours of thevery simple-the effectiveness on birth specified datesrates is the mathematical result of multi- 7. Thosewomen who did not giveinformationplying clinic effectiveness and accept- on menstrual dates were visited at homeability. A pilot study [2] was initiated in withina week of the expected onsetdate, to

learn the date of last menstruation.the Singur Health Centre area, villages inthe Eastern part of India (i) to obtain theindividual and group acceptance of theoral pill, (ii) to assess the biological effec­tiveness of the drug in reducing the preg­nancy rate and (iii) to evolve an economi­cal and effective method of distribution ofthe oral contraceptive under rural con­ditions.

Ill. PLAN OF WORK

In designing the trial, the followingpoints were highlighted in order that theresults obtained from it might be con­clusive.1. A slightmodification in the days of admin­

istration of the drug wasmadeby choosingthe 15th and 22nddays instead of the 16thand 21st days as was the original plan in

108 DEMOGRAPHY

were other methods of family planningand the necessary advice and supply couldbe obtained from the clinic.

The women very much favoured an oralpill, as was evidenced from the fact thatwith a few staff and without making anyintensive campaign, about 40 percent ofthe eligible couples were enrolled within ashort period. Apart from general indif­ference, some of the reasons for unwilling­ness were having no children, having nomale child, having only one male child andhaving few children. 75 percent of theenrolled women were of ages between 20and 34 years. The average age at enroll­ment being 28.4 years and the averageduration of married life was 14.2 years.At the time of enrollment, the women hadan average of 4.4 living children (5.5 livebirths). Most of the women were illiteratewith little knowledge of any family plan­ning method. The main motivational fac­tor for enrollment was apparently stop­ping further child birth rather than spac­ing of pregnancy. On an average for theperiod, 73 percent of the enrolled womenwere reported to be menstruating whilethe remaining 27 percent had not yet re­sumed menstruation after termination oflast pregnancy.

v. CONTRACEPTIVE FAILURE

The women were enrolled after a medi­cal examination in the clinic. Some womencomplained of nausea and vomiting afterdrug intake. On investigation it wasfound that this complaint was frequentwhen the woman took the drug on anempty stomach. The field workers thenadvised the intake of the drug after solidfood. In the village, some women did nottake their meal before 2 P.M. and the fieldworkers faced difficulty in observing thetaking of the drug in their presence. Somewomen took a handful of puffed rice andthen swallowed the tablet. After a month,news of amenorrhoea among the enrolledwomen began to be heard. These womenwere examined in the clinic for diagnosisof pregnancy.

When conception started to occuramong the enrolled women after intake ofthe drug, the non-pregnant women andother women who had not been enrolledthen, enquired of the field workers thereason for conception. All the pregnancieswere not due to drug failure. In a fewcases subsequent evidence showed thatconception occured before enrollment andin a few cases the women missed takingthe drug on the due date. Nearly 50 per­cent of the enrolled women became preg­nant within a period of 3 years. The fieldworkers explained that there would besome failures. But when a woman in theneighbouring house or a wife in the samehousehold became pregnant, the activecases became vocal. They remarked that,it was the field staff who had given thedrug and the drug was taken in their pres­ence and thus the villagers could not beaccused of not cooperating. They said,"If women became pregnant by takingthe drug, it is better to become pregnantby not taking the drug." Thus even dur­ing the home visits, much persuasion hadto be made by the field workers to see thatthe drug was taken in their presence. Bythe end of the study, 27 percent of theenrolled women had discontinued takingthe drug due to reasons other than preg­nancy. Loss of faith in the drug was themost common reason for dropping out.

VI. DISLIKE FOR PREGNANCY

It was found that some enrolled womenwho became pregnant while taking the pilltried to get help to avoid bearing a child.She herself or her husband sought advicefrom the field worker about the course tobe taken to avoid the undesired child.They asked for some medicine or injec­tion for "clearing up the menstruation."At first they did not mention abortion.They were told that no oral medicine orinjection was known to terminate preg­nancy. It was difficult to convince themthat this was true; they strongly believedthat doctors were acquainted with suchmedicine but were not giving it to them.

Experiences with a Poorly Effective OralContraceptive in an Indian Village 109

They felt worried when in spite of use ofsome form of contraceptive, they failed toprevent pregnancy. Some went furtherand enquired about the availability of anoperation that can be done for abortion,its place and cost. They were disappointedwhen they learned that no governmenthospital undertakes this measure. Theyfelt that because they were pregnant dueto the failure of the method, the govern­ment was responsible for the accidentalpregnancy. Thus a social change is beingobserved in some groups of people; inorder to avoid unwanted children they arewilling to have an abortion, especially ifit is possible to get it by taking medicineor an injection.

VlI. LOW CLINIC ATTENDANCE

At the start of the study, more than 50percent of the drug distributions weremade at the Centre. After one year, only10 percent of the drug was administeredat the Centre and in the remaining cases,home-visits had to be paid. The reasonsfor diminishing clinic attendance were:1. The village women did not want to take the

trouble of visiting the Centre only for tak­ing a tablet.

2. Sometimes the women forgot the due datefor taking the drug.

3. On some days, the women were very busywithdomestic work. Onsome religious days,the women did not feel liketaking the drug.

4. The social positionof some women did notpermit them to attend the Centre. Theyevendo not go to the Centre for treatmentof sickness or for ante-natal care.

5. The women, quickly understood that evenif they did not go to the Centre, the staffwould visit them.

6. The villagers lost confidence in the drug asthey saw their neighbouring women getpregnant.

7. Rumours of ill effects after the drug intakewere partly responsible for lackofinitiative.Some women complained of nausea, vomit­ing, palpitation, giddiness, or pain in theabdomen on the day of the drug intake.This was the reason for some discontinua­tion and lack of interest.

Drugs could not be administered onscheduled dates mostly because of failureon the part of women to remember datesor their reluctance to take the drug regu­larly. In some cases, the drug could not beadministered even at home as the womanwas not in the house on the due date. Themajor reasons for discontinuation were illeffects of the drug and loss of faith in thedrug.

VIlI. CONCLUSION

Two questions arise here: (a) Can onlymethods of high effectiveness be advo­cated for use in rural villages? and (b) Isthe need for an educational programmeminimal in case the contraceptive is easyto use? This particular situation indicatedthat the women did not sustain interestunless it had palpable effectiveness. In therural area, the news of failure becameknown to all very quickly and also veryquickly generated an adverse reaction tothe project. In cases of failure after usingthe foam tablet, the women also becamedisgusted. But in many of those cases, thefield workers were able to demonstratethat the women had not used the methodcorrectly. In cases of failure of the rhythmmethod, it was possible to trace the failureto menstrual irregularity of the women.Even where it was not possible to con­vince the individual woman, the wide­spread rumour of failure could be counter­acted. But in the case of this oral pill,which was taken by a majority of womenin the presence of staff, the failure of thedrug itself was obvious. The news of drugfailure spread so rapidly in the village thatit became difficult to convince the womento continue.

With respect to the second question,this experience demonstrates that even incases of contraceptives easy to use, afamily planning educational programmehas to be carried on to raise motivation.The low clinic attendance, the reluctanceto take the drug in the presence of staffetc. only indicated the poor motivationtowards family planning. Without the

110 DEMOGRAPHY

help of the husband, women were not ableto calculate the days on which the drugwould have to be taken. Thus involve­ment of men was found necessary.

The study, on conclusion, could notrecommend the drug for mass distributionon the basis of available data on biologi­cal effectiveness.

REFERENCES1. SANYAL, S. N. An Oral Contraceptive-Its Study Unit of Singur; Alumni Association

Development and Progress; Studies in Family Bulletin, All-India Institute of Hygiene andPlanning; Directorate General of Health Serv-· Public Health, Calcutta; Vol. XI No. 21,ices; Govt. of India, New Delhi. April, 1962.

2. Bastr, R. N. Some Observations of Population