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Canadian Experience with the Margulies Spiral
Canadian Experience 'with the Matgulies Spiral J. WILLIAM D. CORNETT, M.D., and D. L. MAcFADYEN
of 30 Canadian obstetricians and gynecologists in the application of the Margulies spiral (Gynekoil*) has been analyzed. Clinical studies began in the early fall of 1964, before any intrauterine devices were commercially available in Canada. One of the investigators who was later included in our study program had originally begun his own private investigation of the Margulies spiral in December 1963, having obtained supplies directly from Dr. Margulies in New York. Interest in this clinical research program was so great that for the first time in our experience we were unable to supply materials to all those who wished to participate in the study. In the interim this initial enthusiasm appears to have waned. THE EXPERIENCE
PATIENTS
Patient populations from 13 centers extending from Halifax, Nova Scotia, to Nanaimo, British Columbia, are represented. Four series in the total study involved clinic patients; the remaining 26 consisted of patients from private practice. This combined study program covers the period from December 1963 to May 1966, during which time a total of 2400 devices was inserted. The number of patients in each group varied from 9 in the smallest to 227 in the largest, with an average of 80. Of the original 2400 patients, 257 have not as yet returned for their first follow-up visit, leaving a corrected total of 2143 patients for consideration. The ages of the patients were: under 20 years, 59 patients (2.8%); 20-30 years, 1057 (50.6%); 30-40 years, 832 (39.8%); and over 40 years, 141 (6.8%). From Ortho Pharmaceutical (Canada) Ltd., Toronto, Outario, Canada. Presented at the Thirteenth Annual Meeting of The Canadian Society for the Study of Fertility. Jasper, Alberta, Canada, June 20-21, 1966. *Ortho Pharmaceutical (Canada) Ltd., Toronto, Canada.
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This group of patients was highly fertile, representing a total of over 6000 previous deliveries, an average of almost 3 per patient. Parity was: 1 birth, 185 patients (9.7%); 2-4 births, 1305 (68.1%); over 4 births, 381 ( 19.9% ). Only 46 nulliparous patients were included. Several factors had a bearing on the statistical accuracy of this investigation: 1. A number of cases were referred to investigators by other physicians in their area, particularly before the devices were commercially available, and follow-up in many of these was, of necessity, second-hand. 2. The day on which the investigator submitted his patient report forms was considered the closing date for his series. If not otherwise indicated, it was assumed that all devices were in situ at that time. Any patient expelling the coil before this date, but failing to report the expulsion until later, would cause some inaccuracy in the expulsion rate cited. 3. All investigators were asked to inform us of any pregnancies occurring in their series between the time that they originally submitted their records and May 1, 1966. Any patient failing to report a pregnancy to her physician or any investigator failing to report such a pregnancy to us, as requested, would cause an error in the pregnancy rate. 4. Some of the figures cited do not add up to the expected total. Incomplete information regarding some aspects of the study necessitated omission of an occasional patient from some categories. RESULTS Expulsions Of 2143 patients, 166 (7.7%) expelled the device after the first insertion. The expulsion rate increased with each subsequent insertion, 40 in 102 patients (39%) expelling the device a second time; and 11 in 18 (61%), a third time. After as many as 3 attempts, 97 patients (4.5%) were still unable to retain the device. The intervals between the date of insertion and that of expulsion were: first week, 30 (19.4%); 1-4 weeks, 44 (28.6%); 4 weeks to 3 months, 44 (28.6%); 3-6 months, 24 (15.6%); over 6 months, 12 (7.8%). Of 166 expulsions, 154 are noted here; the other 12 patients did not know at exactly what stage the device was expelled. Although the majority of expulsions occurred during the first 3 months, it is important to note that devices continued to be expelled even after many months. This indicates the need for continued postmenstmal self-examination to verify the presence of the device.
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Removals
Overall, 264 devices (12.3%) were removed. Of these, 216 (81.8%) were removed for medical reasons and 48 (18.2%) for nonmedical reasons. By far the commonest reason for removal was irregular and/or excessive bleeding, 136 devices ( 62.9%) having been removed because of postinsertion and intermenstrual bleeding as well as hypermenorrhea. The next most common cause for removal was postinsertion cramps in 43 patients (19.9%). Other less frequent reasons were: infection, 12 patients ( 5.6%); husband complaint, 10 (4.6%); protrusion of tail, 7 (3.2%); tail embedded in cervix, 4 (1.9%); and other, 4 (1.9%). The intervals from insertion to date of removal were: first week, 20 patients (9.3%); 1-4 weeks, 38 (17.5%); 4 weeks to 3 months, 58 (26.gc,t;); 3-6 months, 63 (29.2%); and over 6 months, 37 (17.1%). Most of the patients who had the device removed after 3 months had been experiencing difficulties almost from the outset, but persisted in the hope that the problem would clear up. Seldom did bleeding or cramps become troublesome after 3 months in patients who had not had such difficulty before that time. Other Major Complaints
Among untoward effects not sufficiently disturbing to require removal, bleeding problems again headed the list, 1162 patients (54%) experiencing postinsertion bleeding of more than 24 hr. duration. No postinsertion bleeding was reported in 226 patients (15.4%). The time of the cycle at which the devices were inserted varied with the investigator. Some made the insertion during menstruation; others immediately after; and still others made no particular effort to arrange the appointment at any specific stage of the menstrual cycle. The problem in assessing postinsertion bleeding in those patients in whom the device was inserted during the menses will be appreciated. Although statistical evaluation is difficult, most of the investigators felt that when the spiral was inserted during menstruation, that particular period was almost invariably prolonged. In addition to postinsertion bleeding 246 patients (11.5%) complained of persistent intermenstrual bleeding, and 234 (10.9%) had heavier menstrual flow. These figures refer to those cycles following the initial cycle of insertion only. A total of 527 patients (25%) experienced cramps which persisted for 24 hr. or more, or recurred after 24 hr. The cramps were usually not severe, seldom requiring even mild analgesics. Rarely did cramps become .
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a problem after the first cycle. No cramps were reported by 638 patients in the study (30%). Increased vaginal discharge was reported in 172 patients (8.0%). The discharge was generally nothing more than a physiologic mucous secretion. Cervicitis and endometritis were rarely seen, and only 9 cases of pelvic inflammatory disease were reported in this series-an incidence of 0.4%. In 4 of these cases the spiral was removed. The remaining 5 patients responded well to treatment with the device in situ. An additional 6 patients had the device removed because of infection. These women all had a vaginitis which seemed intractable, and it was believed that removal of the spiral might be advantageous. The husbands of 125 patients (5.8%) complained of some irritation from the protruding tail of the device, and 3 minor lacerations of the penis were reported. In many cases clipping of the tail (sometimes including cauterization of the cut edge) alleviated the problem, although 10 devices were removed at the insistence of the husband. Protrusion of the beaded tail of the spiral beyond 1 or 2 beads, noted at follow-up visits, prompted further clipping in 343 cases (16%). The tail of the spiral became embedded in the cervix in 9 patients, and in 4 cases was removed for this reason. Complete retraction and disappearance of the device within the cervical canal or the uterine cavity· occurred in 8 patients, almost invariably following prior extensive or close clipping of the beaded tail. In only 1 such case did the attending physician feel that removal was indicated. On X-ray examination, 1 spiral was discovered in the cul-de-sac of a patient returning for follow-up examination. Whether the perforation was initiated at the time of insertion, with gradual erosion through the myometrium, is not known. Devices were inserted into 3 patients already pregnant. Two of these patients aborted, and the other, in whom the device was inserted when she was evidently 3 months pregnant, delivered a normal infant at 7~ months. This complication could be avoided by inserting the device during a menstrual period, a practice we strongly recommend. Syncope on insertion was rare in this group; only 14 (0.6%) experienced any degree of faintness. Pregnancies
As of May 1, 1966, 30 unplanned pregnancies had occurred in this group of 2143 patients. The occurrence of pregnancy with the regular and small spiral, respectively, was 25 pregnancies in 2046 patients with an estimated 24,564 cycles, for a rate of 1.2; and 5 pregnancies in 96
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patients with an estimated 1152 cycles, for a rate of 5.2. Among those using the regular spiral, pregnancy occurred in 17 with the device in situ, in 5 with unnoticed expulsion, and in 3 with location of the device undetermined. Of the pregnancies occurring in patients using the small spiral, 3 were with the device in situ and 2 with unnoticed expulsion. We estimate that the patients in this combined study had had the device in place for an average length of use of at least 1 year. As previously indicated, all investigators were asked to notify us of any further pregnancies in their series up to May 1, 1966. The 16 which were reported are included in our figures. In our opinion, with these additional data the pregnancy rates, while obviously not statistically accurate, tend toward error on the high side. It will be seen that the pregnancy rate with the small device was markedly higher than with the regular spiral in this series. However, the relatively few patients (96) fitted with the small device make a statistically sound comparison difficult. Three of the 30 pregnancies resulted in delivery of normal infants, 2 were ectopic, 4 patients suffered abortion (1 apparently self-induced), and the remaining 21 are presumably still pregnant. GENERAL COMMENTS
The incidence of expulsion as related to age shows an interesting correlation. The highest incidence of expulsion is seen in the group under 20 (13%), and a rather remarkable decline in expulsions occurred with each succeeding age group: 20-30 years, 7.7%; 30--40 years, 5.4%; and 40 and over, 2.3%. Expulsions as related to the parity of the patients showed a somewhat less pronounced although obvious decline with increasing parity: para 0, 17%; para 1, 9.3%; para 2-4, 6.6% para 4+, 6.1%. Perhaps in actual fact, age and parity are quite closely related. A similar relationship between age and parity and incidence of expulsion has been reported by Tietze in the Cooperative Statistical Program for the Evaluation of Intra-Uterine Devices, a United States study. It appears from this information that the older patient, para 2 or more, has the best chance of retaining an intrauterine device. In 12 instances where large spirals were expelled and small spirals were subsequently inserted, only 6 of the small spirals were retained. Comparing this second insertion expulsion rate of 50% with the over-all second insertion expulsion rate in our series of 39%, it would appear that there· is no particular advantage in inserting a small spiral into a patient who has already expelled one of regular size.
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Aside from the relatively high pregnancy rate in patients fitted with the small spiral, no other significant differences were evident between this group of patients and those fitted with the regular spiral. As indicated above, only 96 (4.5%) of the patients were fitted with the small spiral, and among these the pregnancy rate was more than four times as high. This would suggest to us that there is very little place for the use of the small device. Perhaps it is suitable only for those patients in whom a regular spiral cannot be inserted. In multiparous women the commonest reason for removal of the device was excessive bleeding, while in nulliparous patients by far the commonest reason for removal was painful cramps. Almost all the nulliparous patients had moderate to severe cramps after insertion, in contrast to a great many multipara who had none. Four of 46 nullipara (8.7%) had syncope on insertion, as opposed to only 10 of 2097 multipara (0.5%), and 17% of nulliparous women expelled the device, as opposed to an over-all expulsion rate of 7.7%. Because of the high incidence of cramps, syncope, and expulsion, the spiral does not appear to be an acceptable method of contraception for the nulliparous patient. By its very nature, the intrauterine contraceptive device makes continued follow-up difficult. There is no need, as with oral contraception, for the patient to replenish supplies constantly, and as a result, many who are having no trouble fail to return to their physician when requested. Because of what we consider inadequate follow-up, we cannot accurately establish a rate for first-year expulsions to compare with the figures quoted in the Sixth Progress Report on Intrauterine Contraception, 3 a study based on data from July 1963 through December 1965. However, it is generally agreed that the majority of expulsions occur in the first 6 months after insertion, and we can determine an accurate expulsion rate for this period of time. The I-year expulsion rates reported by Tietze3 were 22.3 for the regular spiral and 31.6 for the small spiral. Our 6-month rates were 7.5 and 9.0 for the regular and small spiral, respectively. We believe that it is reasonable to suggest that our I-year rates would also be markedly lower, since we have shown quite clearly that the incidence of expulsion decreases decidedly after the first 3 months. As might be expected, the incidence of pelvic inflammatory disease was much lower in our study (0.4%, regular spiral; 1.1%, small spiral) than in the Cooperative Program in the United States, where the great majority of patients were from clinics (3.5%, regular spiral; 2.1%, small spiral). No attempt was made to compare statistically the results of one in-
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vestigator with another. However, it was quite evident to us that, generally speaking, the more experience an investigator had with intrauterine devices, the fewer problems his patients encountered. Early in the program many more difficulties were encountered, and more devices were either expelled or removed. As experience was gained, the incidence of all such problems declined. In this connection, it is noteworthy that in this combined study program, the highest expulsion rate was in one of the clinic groups where interns in rotation were performing most of the insertions. Also, all 3 insertions into patients already pregnant occurred in such clinic groups, as did the single uterine perforation. Perhaps similar clinic situations existing in the United States may account, in part, at least, for the discrepancy between our figures for expulsion and those quoted in the United States program. 3 One investigator inserted the spiral into 22 early postpartum patients. The time of insertion ranged from the first postpartum day to 1 month following delivery, although 73% were inserted in the first week. It is of interest that of 12 devices inserted during the first 5 postpartum days, 6 ( 50%) were expelled, whereas only 2 (20%) of the 10 spirals inserted after the fifth day were expelled. This high expulsion rate for devices inserted during the first 5 postpartum days has recently been reported in two larger studies, as yet unpublished. 1 • 2 It thus appears that there may be a rather critical stage post partum, following which the expulsion rate reverts rather rapidly to "normal." We feel that our experience, confirmed by others, suggests that the first 5 days postpartum is not a satisfactory period for insertion of intrauterine devices. Initial Papanicolaou smears revealed 3 cases of carcinoma in situ in patients requesting the spiral. One additional smear taken from a patient 10 months after insertion of the spiral revealed an adenocarcinoma. It was felt by the investigator that the spiral could in no way be held responsible for this development since no initial smear had been taken. In every case where follow-up smears have been taken they have been negative. SUMMARY AND CONCLUSIONS
The results of a study of the Margulies spiral, regular and small size, by 30 Canadian investigators, involving 2143 patients, are presented. Expulsion occurred in 7.7% of patients. The incidence of expulsion declined with increasing age and parity, the older multiparous patient being the best candidate for an intrauterine device. The spiral is considered inappropriate for the nulliparous patient.
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Evidence suggests that it is inadvisable to insert intrauterine devices during the first 5 days post partum. The percentage of spirals removed was 12.3%, two-thirds of these for either bleeding or cramps. The pregnancy rate using the regular spiral was 1.2; in 96 patients fitted with the small spiral the pregnancy rate was 5.2. It is felt that the small spiral is of limited value. The incidence of infection was extremely low, and all follow-up "Pap" smears were negative. It is obvious that as investigators gain experience with the device, the incidence of almost all complications and problems decreases. ADDENDUM
Two modifications of the Margulies spiral (Fig. 1) have been under investigation for the past lO months by 22 investigators in lO Canadian centers. In both the "distally" and "centilly" devices, nylon threads replace the beaded polyethylene tail of the standard spiral (Fig. 2). In the one they replace from the distal end; in the other, from the center.
Fig. 1 (left). Modified Margulies spiral. In both "distally" (left) and "centilIy" (right) devices, nylon threads replace beaded polyethylene tail of standard spiral.. Fig. 2 (right). Standard Margulies spiral (Gynekoil); regular size at left, small size at right.
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The 414 patients studied to date have not been followed long enough to permit any firm conclusions. However, it is our impression that no significant decrease in the pregnancy rate or in the incidence of expulsion is to be expected. There may prove to be less bleeding, and obviously husband complaints are no longer a problem. Evaluation of these modified devices is continuing. 19 Green Belt Dr. Don Mills, Ont., Canada
REFERENCES 1. GIBSON, R. R., and J. LAWLER. Clinical Evaluation of an Intrauterine Contraceptive Device in the Immediate Post Partum Period. Presented at the Fourth Annual Meeting of the American Association of Planned Parenthood Physicians, Denver, Colo., Apr. 27, 1966. 2. SWARTZ, D. P. Early Post Partum Intrauterine Device Insertion. Presented at the Fourth Annual Meeting of the American Association of Planned Parenthood Physicians, Denver, Colo., Apr. 27, 1966. 3. TIETZE, C. Sixth Progress Report on Intrauterine Contraception. Presented at the Fourth Annual Meeting of the American Association of Planned Parenthood Physicians, Denver, Colo., Apr. 26, 1966.
Announcement Dr. Walter W. Williams, a founding member of the American Society for the Study of Sterility, has offered copies of his book, Sterility-The Diagnostic Study of the Infertile Couple, to members of the American Fertility Society at a special price of $24.50 on purchases made on or before April 1, 1967. Thereafter the price will be $28.50. Any member who wishes to take advantage of the reduced price should write to Walter W. Williams, M.D., 20 Magnolia Terrace, Springfield, Mass. 01108.
of 30 Canadian obstetricians and gynecologists in the application of the Margulies spiral (Gynekoil*) has been analyzed. Clinical studies began in the early fall of 1964, before any intrauterine devices were commercially available in Canada. One of the investigators who was later included in our study program had originally begun his own private investigation of the Margulies spiral in December 1963, having obtained supplies directly from Dr. Margulies in New York. Interest in this clinical research program was so great that for the first time in our experience we were unable to supply materials to all those who wished to participate in the study. In the interim this initial enthusiasm appears to have waned. THE EXPERIENCE
PATIENTS
Patient populations from 13 centers extending from Halifax, Nova Scotia, to Nanaimo, British Columbia, are represented. Four series in the total study involved clinic patients; the remaining 26 consisted of patients from private practice. This combined study program covers the period from December 1963 to May 1966, during which time a total of 2400 devices was inserted. The number of patients in each group varied from 9 in the smallest to 227 in the largest, with an average of 80. Of the original 2400 patients, 257 have not as yet returned for their first follow-up visit, leaving a corrected total of 2143 patients for consideration. The ages of the patients were: under 20 years, 59 patients (2.8%); 20-30 years, 1057 (50.6%); 30-40 years, 832 (39.8%); and over 40 years, 141 (6.8%). From Ortho Pharmaceutical (Canada) Ltd., Toronto, Outario, Canada. Presented at the Thirteenth Annual Meeting of The Canadian Society for the Study of Fertility. Jasper, Alberta, Canada, June 20-21, 1966. *Ortho Pharmaceutical (Canada) Ltd., Toronto, Canada.
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This group of patients was highly fertile, representing a total of over 6000 previous deliveries, an average of almost 3 per patient. Parity was: 1 birth, 185 patients (9.7%); 2-4 births, 1305 (68.1%); over 4 births, 381 ( 19.9% ). Only 46 nulliparous patients were included. Several factors had a bearing on the statistical accuracy of this investigation: 1. A number of cases were referred to investigators by other physicians in their area, particularly before the devices were commercially available, and follow-up in many of these was, of necessity, second-hand. 2. The day on which the investigator submitted his patient report forms was considered the closing date for his series. If not otherwise indicated, it was assumed that all devices were in situ at that time. Any patient expelling the coil before this date, but failing to report the expulsion until later, would cause some inaccuracy in the expulsion rate cited. 3. All investigators were asked to inform us of any pregnancies occurring in their series between the time that they originally submitted their records and May 1, 1966. Any patient failing to report a pregnancy to her physician or any investigator failing to report such a pregnancy to us, as requested, would cause an error in the pregnancy rate. 4. Some of the figures cited do not add up to the expected total. Incomplete information regarding some aspects of the study necessitated omission of an occasional patient from some categories. RESULTS Expulsions Of 2143 patients, 166 (7.7%) expelled the device after the first insertion. The expulsion rate increased with each subsequent insertion, 40 in 102 patients (39%) expelling the device a second time; and 11 in 18 (61%), a third time. After as many as 3 attempts, 97 patients (4.5%) were still unable to retain the device. The intervals between the date of insertion and that of expulsion were: first week, 30 (19.4%); 1-4 weeks, 44 (28.6%); 4 weeks to 3 months, 44 (28.6%); 3-6 months, 24 (15.6%); over 6 months, 12 (7.8%). Of 166 expulsions, 154 are noted here; the other 12 patients did not know at exactly what stage the device was expelled. Although the majority of expulsions occurred during the first 3 months, it is important to note that devices continued to be expelled even after many months. This indicates the need for continued postmenstmal self-examination to verify the presence of the device.
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Removals
Overall, 264 devices (12.3%) were removed. Of these, 216 (81.8%) were removed for medical reasons and 48 (18.2%) for nonmedical reasons. By far the commonest reason for removal was irregular and/or excessive bleeding, 136 devices ( 62.9%) having been removed because of postinsertion and intermenstrual bleeding as well as hypermenorrhea. The next most common cause for removal was postinsertion cramps in 43 patients (19.9%). Other less frequent reasons were: infection, 12 patients ( 5.6%); husband complaint, 10 (4.6%); protrusion of tail, 7 (3.2%); tail embedded in cervix, 4 (1.9%); and other, 4 (1.9%). The intervals from insertion to date of removal were: first week, 20 patients (9.3%); 1-4 weeks, 38 (17.5%); 4 weeks to 3 months, 58 (26.gc,t;); 3-6 months, 63 (29.2%); and over 6 months, 37 (17.1%). Most of the patients who had the device removed after 3 months had been experiencing difficulties almost from the outset, but persisted in the hope that the problem would clear up. Seldom did bleeding or cramps become troublesome after 3 months in patients who had not had such difficulty before that time. Other Major Complaints
Among untoward effects not sufficiently disturbing to require removal, bleeding problems again headed the list, 1162 patients (54%) experiencing postinsertion bleeding of more than 24 hr. duration. No postinsertion bleeding was reported in 226 patients (15.4%). The time of the cycle at which the devices were inserted varied with the investigator. Some made the insertion during menstruation; others immediately after; and still others made no particular effort to arrange the appointment at any specific stage of the menstrual cycle. The problem in assessing postinsertion bleeding in those patients in whom the device was inserted during the menses will be appreciated. Although statistical evaluation is difficult, most of the investigators felt that when the spiral was inserted during menstruation, that particular period was almost invariably prolonged. In addition to postinsertion bleeding 246 patients (11.5%) complained of persistent intermenstrual bleeding, and 234 (10.9%) had heavier menstrual flow. These figures refer to those cycles following the initial cycle of insertion only. A total of 527 patients (25%) experienced cramps which persisted for 24 hr. or more, or recurred after 24 hr. The cramps were usually not severe, seldom requiring even mild analgesics. Rarely did cramps become .
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a problem after the first cycle. No cramps were reported by 638 patients in the study (30%). Increased vaginal discharge was reported in 172 patients (8.0%). The discharge was generally nothing more than a physiologic mucous secretion. Cervicitis and endometritis were rarely seen, and only 9 cases of pelvic inflammatory disease were reported in this series-an incidence of 0.4%. In 4 of these cases the spiral was removed. The remaining 5 patients responded well to treatment with the device in situ. An additional 6 patients had the device removed because of infection. These women all had a vaginitis which seemed intractable, and it was believed that removal of the spiral might be advantageous. The husbands of 125 patients (5.8%) complained of some irritation from the protruding tail of the device, and 3 minor lacerations of the penis were reported. In many cases clipping of the tail (sometimes including cauterization of the cut edge) alleviated the problem, although 10 devices were removed at the insistence of the husband. Protrusion of the beaded tail of the spiral beyond 1 or 2 beads, noted at follow-up visits, prompted further clipping in 343 cases (16%). The tail of the spiral became embedded in the cervix in 9 patients, and in 4 cases was removed for this reason. Complete retraction and disappearance of the device within the cervical canal or the uterine cavity· occurred in 8 patients, almost invariably following prior extensive or close clipping of the beaded tail. In only 1 such case did the attending physician feel that removal was indicated. On X-ray examination, 1 spiral was discovered in the cul-de-sac of a patient returning for follow-up examination. Whether the perforation was initiated at the time of insertion, with gradual erosion through the myometrium, is not known. Devices were inserted into 3 patients already pregnant. Two of these patients aborted, and the other, in whom the device was inserted when she was evidently 3 months pregnant, delivered a normal infant at 7~ months. This complication could be avoided by inserting the device during a menstrual period, a practice we strongly recommend. Syncope on insertion was rare in this group; only 14 (0.6%) experienced any degree of faintness. Pregnancies
As of May 1, 1966, 30 unplanned pregnancies had occurred in this group of 2143 patients. The occurrence of pregnancy with the regular and small spiral, respectively, was 25 pregnancies in 2046 patients with an estimated 24,564 cycles, for a rate of 1.2; and 5 pregnancies in 96
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patients with an estimated 1152 cycles, for a rate of 5.2. Among those using the regular spiral, pregnancy occurred in 17 with the device in situ, in 5 with unnoticed expulsion, and in 3 with location of the device undetermined. Of the pregnancies occurring in patients using the small spiral, 3 were with the device in situ and 2 with unnoticed expulsion. We estimate that the patients in this combined study had had the device in place for an average length of use of at least 1 year. As previously indicated, all investigators were asked to notify us of any further pregnancies in their series up to May 1, 1966. The 16 which were reported are included in our figures. In our opinion, with these additional data the pregnancy rates, while obviously not statistically accurate, tend toward error on the high side. It will be seen that the pregnancy rate with the small device was markedly higher than with the regular spiral in this series. However, the relatively few patients (96) fitted with the small device make a statistically sound comparison difficult. Three of the 30 pregnancies resulted in delivery of normal infants, 2 were ectopic, 4 patients suffered abortion (1 apparently self-induced), and the remaining 21 are presumably still pregnant. GENERAL COMMENTS
The incidence of expulsion as related to age shows an interesting correlation. The highest incidence of expulsion is seen in the group under 20 (13%), and a rather remarkable decline in expulsions occurred with each succeeding age group: 20-30 years, 7.7%; 30--40 years, 5.4%; and 40 and over, 2.3%. Expulsions as related to the parity of the patients showed a somewhat less pronounced although obvious decline with increasing parity: para 0, 17%; para 1, 9.3%; para 2-4, 6.6% para 4+, 6.1%. Perhaps in actual fact, age and parity are quite closely related. A similar relationship between age and parity and incidence of expulsion has been reported by Tietze in the Cooperative Statistical Program for the Evaluation of Intra-Uterine Devices, a United States study. It appears from this information that the older patient, para 2 or more, has the best chance of retaining an intrauterine device. In 12 instances where large spirals were expelled and small spirals were subsequently inserted, only 6 of the small spirals were retained. Comparing this second insertion expulsion rate of 50% with the over-all second insertion expulsion rate in our series of 39%, it would appear that there· is no particular advantage in inserting a small spiral into a patient who has already expelled one of regular size.
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Aside from the relatively high pregnancy rate in patients fitted with the small spiral, no other significant differences were evident between this group of patients and those fitted with the regular spiral. As indicated above, only 96 (4.5%) of the patients were fitted with the small spiral, and among these the pregnancy rate was more than four times as high. This would suggest to us that there is very little place for the use of the small device. Perhaps it is suitable only for those patients in whom a regular spiral cannot be inserted. In multiparous women the commonest reason for removal of the device was excessive bleeding, while in nulliparous patients by far the commonest reason for removal was painful cramps. Almost all the nulliparous patients had moderate to severe cramps after insertion, in contrast to a great many multipara who had none. Four of 46 nullipara (8.7%) had syncope on insertion, as opposed to only 10 of 2097 multipara (0.5%), and 17% of nulliparous women expelled the device, as opposed to an over-all expulsion rate of 7.7%. Because of the high incidence of cramps, syncope, and expulsion, the spiral does not appear to be an acceptable method of contraception for the nulliparous patient. By its very nature, the intrauterine contraceptive device makes continued follow-up difficult. There is no need, as with oral contraception, for the patient to replenish supplies constantly, and as a result, many who are having no trouble fail to return to their physician when requested. Because of what we consider inadequate follow-up, we cannot accurately establish a rate for first-year expulsions to compare with the figures quoted in the Sixth Progress Report on Intrauterine Contraception, 3 a study based on data from July 1963 through December 1965. However, it is generally agreed that the majority of expulsions occur in the first 6 months after insertion, and we can determine an accurate expulsion rate for this period of time. The I-year expulsion rates reported by Tietze3 were 22.3 for the regular spiral and 31.6 for the small spiral. Our 6-month rates were 7.5 and 9.0 for the regular and small spiral, respectively. We believe that it is reasonable to suggest that our I-year rates would also be markedly lower, since we have shown quite clearly that the incidence of expulsion decreases decidedly after the first 3 months. As might be expected, the incidence of pelvic inflammatory disease was much lower in our study (0.4%, regular spiral; 1.1%, small spiral) than in the Cooperative Program in the United States, where the great majority of patients were from clinics (3.5%, regular spiral; 2.1%, small spiral). No attempt was made to compare statistically the results of one in-
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vestigator with another. However, it was quite evident to us that, generally speaking, the more experience an investigator had with intrauterine devices, the fewer problems his patients encountered. Early in the program many more difficulties were encountered, and more devices were either expelled or removed. As experience was gained, the incidence of all such problems declined. In this connection, it is noteworthy that in this combined study program, the highest expulsion rate was in one of the clinic groups where interns in rotation were performing most of the insertions. Also, all 3 insertions into patients already pregnant occurred in such clinic groups, as did the single uterine perforation. Perhaps similar clinic situations existing in the United States may account, in part, at least, for the discrepancy between our figures for expulsion and those quoted in the United States program. 3 One investigator inserted the spiral into 22 early postpartum patients. The time of insertion ranged from the first postpartum day to 1 month following delivery, although 73% were inserted in the first week. It is of interest that of 12 devices inserted during the first 5 postpartum days, 6 ( 50%) were expelled, whereas only 2 (20%) of the 10 spirals inserted after the fifth day were expelled. This high expulsion rate for devices inserted during the first 5 postpartum days has recently been reported in two larger studies, as yet unpublished. 1 • 2 It thus appears that there may be a rather critical stage post partum, following which the expulsion rate reverts rather rapidly to "normal." We feel that our experience, confirmed by others, suggests that the first 5 days postpartum is not a satisfactory period for insertion of intrauterine devices. Initial Papanicolaou smears revealed 3 cases of carcinoma in situ in patients requesting the spiral. One additional smear taken from a patient 10 months after insertion of the spiral revealed an adenocarcinoma. It was felt by the investigator that the spiral could in no way be held responsible for this development since no initial smear had been taken. In every case where follow-up smears have been taken they have been negative. SUMMARY AND CONCLUSIONS
The results of a study of the Margulies spiral, regular and small size, by 30 Canadian investigators, involving 2143 patients, are presented. Expulsion occurred in 7.7% of patients. The incidence of expulsion declined with increasing age and parity, the older multiparous patient being the best candidate for an intrauterine device. The spiral is considered inappropriate for the nulliparous patient.
VOL. 18, No.2, 1967
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Evidence suggests that it is inadvisable to insert intrauterine devices during the first 5 days post partum. The percentage of spirals removed was 12.3%, two-thirds of these for either bleeding or cramps. The pregnancy rate using the regular spiral was 1.2; in 96 patients fitted with the small spiral the pregnancy rate was 5.2. It is felt that the small spiral is of limited value. The incidence of infection was extremely low, and all follow-up "Pap" smears were negative. It is obvious that as investigators gain experience with the device, the incidence of almost all complications and problems decreases. ADDENDUM
Two modifications of the Margulies spiral (Fig. 1) have been under investigation for the past lO months by 22 investigators in lO Canadian centers. In both the "distally" and "centilly" devices, nylon threads replace the beaded polyethylene tail of the standard spiral (Fig. 2). In the one they replace from the distal end; in the other, from the center.
Fig. 1 (left). Modified Margulies spiral. In both "distally" (left) and "centilIy" (right) devices, nylon threads replace beaded polyethylene tail of standard spiral.. Fig. 2 (right). Standard Margulies spiral (Gynekoil); regular size at left, small size at right.
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FERTILITY & STERILITY
The 414 patients studied to date have not been followed long enough to permit any firm conclusions. However, it is our impression that no significant decrease in the pregnancy rate or in the incidence of expulsion is to be expected. There may prove to be less bleeding, and obviously husband complaints are no longer a problem. Evaluation of these modified devices is continuing. 19 Green Belt Dr. Don Mills, Ont., Canada
REFERENCES 1. GIBSON, R. R., and J. LAWLER. Clinical Evaluation of an Intrauterine Contraceptive Device in the Immediate Post Partum Period. Presented at the Fourth Annual Meeting of the American Association of Planned Parenthood Physicians, Denver, Colo., Apr. 27, 1966. 2. SWARTZ, D. P. Early Post Partum Intrauterine Device Insertion. Presented at the Fourth Annual Meeting of the American Association of Planned Parenthood Physicians, Denver, Colo., Apr. 27, 1966. 3. TIETZE, C. Sixth Progress Report on Intrauterine Contraception. Presented at the Fourth Annual Meeting of the American Association of Planned Parenthood Physicians, Denver, Colo., Apr. 26, 1966.
Announcement Dr. Walter W. Williams, a founding member of the American Society for the Study of Sterility, has offered copies of his book, Sterility-The Diagnostic Study of the Infertile Couple, to members of the American Fertility Society at a special price of $24.50 on purchases made on or before April 1, 1967. Thereafter the price will be $28.50. Any member who wishes to take advantage of the reduced price should write to Walter W. Williams, M.D., 20 Magnolia Terrace, Springfield, Mass. 01108.