A Comparison of the Efficacy and Acceptability of the Copper-7 Intrauterine Device Following Immediate or Delayed Insertion After First-Trimester Therapeutic Abortion*

FERTWTY AND 8TEIm.ITv Copyright c 1980 The American Fertility Society

Vol. 34, No.2, August 1980 Printed in U.SA.

A COMPARISON OF THE EFFICACY AND ACCEPTABILITY OF THE COPPER·7 INTRAUTERINE DEVICE FOLLOWING IMMEDIATE OR DELAYED INSERTION AFTER FIRST·TRIMESTER THERAPEUTIC ABORTION*

PETER G. GILLETT, M.D., F.R.C.8.(Clt NICHOLAS H. LEE, M.D., F.R.C.8.(Cl* A. ALBERT YUZPE, M.D., F.R.C.S.(C)§ IRENE CERSKUS, PH.D.~

Montreal General Hospital, Montreal, Quebec, Vancouver General Hospital, Vancouver, British Columbia, University Hospital, London, Ontario, andG. D. Searle & Company of Canada, Limited, Oakville, Ontario, Canada

The incidence of untoward events in 144 women who underwent insertion of the Copper-7 (Cu-7) intrauterine device at the time of vacuum aspiration for therapeutic abortion did not differ significantly from that in 63 women who returned 33 ± 1.2 days following abortion for insertion of the device. Cramps and bleeding were no more severe following immediate postabortion insertion of the Cu-7 than following abortion only. During the I-year follow-up period, the groups did not differ significantly in the total termination rate for medical reasons, although at 1 month postinsertion more women in the delayed-insertion group had the device removed because of pain and bleeding. There was a trend toward an increased incidence of expulsion in the immediate-insertion group. Two involuntary pregnancies occurred in the immediate-insertion group; no pregnancies were reported in the delayed-insertion group. During their one year of evaluation, 31.9% of the immediate-insertion group and 42.9% of the delayed-insertion group were lost to follow-up. The advantages of immediate postabortion insertion include the necessity for a single clinic visit for both extraction and insertion, and thus a single episode of discomfort; immediate contraceptive protection; and acceptance by a larger number of women. Fertil Steril 34:121,1980

The increasing incidence of repeated therapeutic abortion suggests that there is a need for effective contraceptive methods which can be initiated at the time of the first procedure. Patient motivation at this time is usually high, and advantage

~

should be taken of this desire for protection against a subsequent unwanted pregnancy. Current labeling for the Copper-7 (Cu-7) states that this intrauterine device (IUD) should not be inserted postpartum or postabortion until involution of the uterus is complete in order to avoid a higher incidence of perforation or expulsion. Nevertheless, studies of immediate postabortion insertion of an IUD have shown encouraging results. 1-4 The present study was undertaken to confirm and extend these observations by assessing the safety and acceptability of immediate insertion of the Cu-7 following first-trimester therapeutic abortion as compared with insertion approximately 1 month thereafter.

Received February 1, 1980; revised April 10, 1980; accepted June 24, 1980. *Supported by G. D. Searle & Company of Canada, Limited, and the Canadian Committee for Fertility Research. tTo whom reprint requests should be addressed at Montreal General Hospital, Montreal, Quebec, H3G 1A4, Canada. :j:Vancouver General Hospital. §University Hospital. ~G. D. Searle & Company of Canada, Limited.

i.

I

121

122

TABLE 1. Patient Population and Symptoms following Therapeutic Abortion Immediate-insertion group

No.

Age ,,;;30 >30 Not indicated Parity Nulliparous Parous Not indicated Previous therapeutic abortions None 1 ~2

Not indicated Symptoms prior to discharge a Cramps Mild Moderate Bleeding Mild Moderate

Delayed-insertion group

o/c

No.

o/c

96 34 14

66.6 24.7 9.7

46 12 5

73.0 19.1 7.9

82 59 3

56.9 41.0 2.1

40 20 3

63.5 31.7 4.8

89 37 15 3

61.8 25.7 10.4 2.1

44 13 3 3

69.8 20.6 4.8 4.8

74 14

51.4 9.7

40 1

63.5 1.6

105 3

72.9 2.1

50 2

79.4 3.2

aFor the immediate-insertion group, symptoms reported after abortion and insertion; for the delayed-insertion group, those reported after abortion only. METHODS

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August 1980

GILLETT ET AL.

Women undergoing vacuum aspiration for therapeutic abortion and requesting an IUD following this procedure were assigned on a balanced, random basis to one of two groups. One group (immediate-insertion grgup) received a Cu-7 at the time of the procedure; the second group (delayed-insertion group) returned for insertion of the device between 3 and 5 weeks after abortion. Follow-up visits were scheduled at 1, 4, and 12 months after insertion. At these visits, a pelvic examination was performed and any complaints were noted. Patients gave informed, written consent to participate in the study. The data were subjected to life-table analysis according to the log-rank method of Azen et a1. 5 Partial or complete expulsion of the Cu-7, pregnancy, removal of the device for any reason, or loss to follow-up resulted in the patient's being excluded from the study. RESULTS

At three study sites, a total of 259 women were entered into the study, although 7 of these subsequently decided against therapuetic abortion. Forty-three of the women assigned to the delayed-

insertion group failed to return for insertion; one insertion was canceled because of a postabortion pelvic infection; and one ectopic pregnancy was discovered prior to insertion. Immediate postabortion insertion was performed in 144 women, and insertion was delayed in 63 women. There were no significant differences in either the physical characteristics of the two groups or the incidence of cramps and bleeding immediately after abortion and prior to discharge from the hospital (Table 1); however, symptoms recorded in the immediate-insertion group were both postabortion and postinsertion whereas in the delayed-insertion group they were postabortion only. Cramps and bleeding reported at the 1-month follow-up visit are detailed in Table 2. No significant differences were detected in duration or severity of bleeding or pain in the two groups. Throughout the study period, 46 patients (31.9%) in the immediate-insertion group and 27 (42.9%) in the delayed-insertion group failed to return for scheduled visits. In approximately onehalf of these cases, the women were not examined after insertion of the device. Table 3 shows the cumulative termination rates, calculated as a dayby-day life-table, in the immediate- and delayed-insertion groups. Two involuntary pregnancies occurred in the immediate-insertion group, and both patients underwent another therapeutic abortion. No involuntary pregnancies occurred in the delayed-insertion group. A single expulsion was recorded in the delayed-insertion group. Fifteen expulsions, nine of which were parTABLE 2. Cramps and Bleeding after Immediate and Delayed Postabortion Insertion ofCu-7

Bleeding after insertion Duration, days (mean ± SEM) No. of patients Amount

Immediate-insertion group

Delayed·inser· tion group

13.5 ± 0.90

10.9 ± 1.81

97

37

No.

%a

No.

o/ca

None Spotting Menstrual-like flow Excessive Not indicated Cramps after insertion Mild Moderate Severe

2 35 46 7 7

2.1 36.1 47.4 7.2 7.2

1 8 19 5 8

2.4 19.5 46.3 12.2 19.5

55 11 7

56.7 11.3 7.2

17 5 5

41.4 12.2 12.2

Patients seen

97

41

aPercentage figures are based on number of patients seen at the I-month follow-up visit.

Vol. 34, No.2

123

EFFICACY AND ACCEPTABILITY OF CU-7 IUD AFTER ABORTION

TABLE 3. Net Cumulative Termination Rates with Respect to Study Duration in Immediate-Insertion and Delayed-Insertion Groups Termination rate llA>ason for termination

1 rno after insertion

Involuntary pregnancy Expulsion Removal for Bleeding/pain Other medical reason Total medical terminations Women-days of use

(
Immediate-insertion group

Delayed-insertion group

1 yr after insertion

1 rno after insertion

1 yr after insertion

0.0 6.6

2.3 15.4

0.0 0.0

0.0 2.8

1.8 2.5

14.9 4.8

10.3 0.0

24.9 2.9

10.6

33.1

10.3

29,1

3,371

tial expulsions, were reported in the immediate-insertion group. No pregnancies were associated with these expulsions, nor was there a relationship between the incidence of expulsion and cervical dilatation at the time of extraction. Three devices in the immediate-insertion group were removed because of pelvic inflammatory disease. There were no cases of proven infection after insertion in the delayed-insertion group. However, there was a single case of postabortion infection (1.6% incidence), and the patient was therefore not fitted with the device. Significantly more women in the delayed-insertion group had the IUD removed for bleeding/pain within 1 month of insertion. However, 1 year after insertion the removal rates for bleeding/pain in the two groups were not significantly different. Total removal rates for any medical reason were very similar in the two groups, both at 1 month and 1 year following insertion. DISCUSSION

Possibly at no time in her reproductive years is a woman more motivated to employ effective contraception than following the termination of an unwanted pregnancy. Several studies have shown that initiation of contraception at the time of abortion is desirable. Return of ovulation has been reported as early as the 10th day following abortion,6 and Lahteenmaki and Luukkainen7 detected ovulation in 83% of their patients during the first postabortion cycle. In the present study, 34.9% of patients in the delayed-insertion group reported menses after abortion and prior to insertion (an average interval of 33 days). In the immediate-insertion group, 49.5% of women reported menses by the I-month follow-up visit. It is to be expected that a greater percentage had ovulated

25,201

1,427

9.561

by that time. Initiation of contraception at the time of abortion therefore appears desirable, especially for those women with low levels of motivation. Fear of increased untoward effects such as perforation, infection, and expulsion has prevented a more widespread use ofthe IUD immediately after abortion. However, in the past 5 to 10 years encouraging data have been reported in this connection. Many studies of IUD insertion immediately after abortion have included a "control" group of patients in whom insertion was performed without prior abortion, or retrospective comparisons with intermenstrual insertions were made. As suggested by Mishell, 8 the present study attempted to overcome any differences in experience of the physician performing the insertion, factors related to clinic attitude, and the time period during which the insertions were performed. Patients were assigned on a balanced, random basis to either an immediate-insertion group or a delayed-insertion group. However, 41.7% of patients assigned to the delayed-insertion group failed to return for insertion ofthe device. Boria and Gordon 9 reported that approximately 55% of their patients are lost to follow-up after elective abortion. This, in itself, attests to rapid decline of motivation once the patient leaves the hospital. Nonetheless, a high dropout rate appears to be an insurmountable problem in a study of this type, and a valuable point is made: for the patient who undergoes elective abortion and who selects an IUD as a contraceptive method, the chances are about 50% that she will actually return for insertion at a later date when she is no longer pregnant. The results reported herein have confirmed the safety of immediate postabortion insertion of the Cu-7 reported by others.1-4 The duration and

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GILLETT ET AL.

severity of pain and bleeding after immediate postabortion insertion of the device did not differ significantly from those reported after abortion only or delayed insertion of the Cu-7. Studies of immediate postabortion insertion of an IUD have not shown increased rates of expulsion. Larsson and Hamberger,3 in a series of 551 insertions of the Cu-7 immediately postabortion, reported expulsions in 4% of their patients within 11 months after insertion. Although the 1-year expulsion rate found in our series is considerably higher (15.4%), it did not differ significantly from that in the delayed-insertion group (2.8%). A reasonable conclusion based on our data is that there seems to be a trend toward an increased frequency of expulsion after immediate postabortion insertion. Boria and Gordon 9 stated that, in their experience, the incidence of pelvic infections that could be associated with the use of an IUD was between 2% and 3%, and that the postabortion insertion of an IUD did not increase this risk. The present study supports this view. At the 1-month followup, the infection rate of 1.8% in the immediate-insertion group compares favorably with the incidence of 1.6% reported in the delayed-insertion group after abortion only, prior to insertion. When total rates of termination for medical reasons are compared in the two groups, at any point in the study, no significant differences are observed. In fact, despite differences in sample size, the termination rates are strikingly similar. Immediate postabortion insertion of the Cu-7 carries several adva~tages: the necessity for a single hospital/clinic visit during which both extraction and insertion are performed and the patient is subjected to a single episode of discomfort and bleeding; immediate contraceptive protection; and

acceptance by a larger number of patients. Moreover, the present study does not support the hypothesis that significantly higher rates of untoward events accompany IUD insertion at the time of abortion. Acknowledgments. Special thanks are extended to Mme. Lucie Pepin for the collection of data and to Dr. Robert G. Burford for his enthusiasm and encouragement at all times during the study. REFERENCES 1. Andolsek L: The Ljubjana IUD experience: ten years. In

2. 3.

4.

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9.

Analysis ofIntrauterine Contraception: Proceedings ofthe 3rd International Conference on Intrauterine Contraception, Cairo, Arab Republic of Egypt, 1974, Edited by F Hefnawi, SJ Segal. Amsterdam, North-Holland Publishing Co, 1975, p 205 Tatum HJ: Intrauterine contraception. Am J Obstet Gynecol 112:1000, 1972 Larsson B, Hamberger L: Insertion ofCu-7 IUDs in connection with induced abortions during the first trimester. Contraception 12:69, 1975 Newton J, Elias J, Johnson A: Immediate post-termination insertion of Cu-7 and Dalkon Shield intrauterine contraceptive devices. J Obstet Gynaecol Br Commonw 81:389, 1974 Azen SP, Roy S, Pike MC, Gasagrande J: Some suggested improvements to current statistical methods of analyzing contraceptive efficacy. J Chronic Dis 29:649, 1976 Boyd EF, Holstrom EG: Ovulation following therapeutic abortion. Am J Obstet Gynecol 113:469, 1972 Lahteenmaki P, Luukkainen T: Return of ovarian function after abortion. Clin Endocrinol 8:123, 1978 Mishell DR: The clinic factor in evaluating IUDs. In Analysis of Intrauterine Contraception: Proceedings of the 3rd International Conference on Intrauterine Contraception, Cairo, Arab Republic of Egypt, 1974, Edited by F Hefnawi, SJ Segal. Amsterdam, North-Holland Publishing Co, 1975, p 27 Boria MC, Gordon M: What to expect when you insert an IUD. Med Times 103:98, 1975