The Copper T 220C: A new long-acting copper intrauterine contraceptive device DONNA L. COOPER, M.D. ANITA K. MILLEN, M.D. DANIEL R. MISHELL, jR., M.D. Los Angeles, California
The Copper T(TCu) intrauterine contraceptive device (IUD) has been found to be an effective method of contraception but has the disadvantage of needing periodic replacement due to loss of copper through dissolution and fragmentation of the copper wire. Modification of the Copper T to overcome this disadvantage involved substitution of copper sleeves for wire on the vertical arm and the addition of copper sleeves to the horizontal arms to give an effective surface area of 220 sq. mm. of copper and an estimated life span of 20 years. A randomized comparative study was undertaken in 999 women to determine if the new model performed as well as the wire-wound Copper T 300. Net cumulative first-event rates at one year were as follows: TCu 220C-pregnancy 0.9, expulsion 3.7, removal for pain or bleeding 14.4; TCu 300-pregnancy 1.1, expulsion 3.1, removal for pain or bleeding 9.3. None of the differences in event rates were significant. If long-term follow-up confirms these findings, this new long-lasting copper intrauterine device could become the IUD of choice for all women.
this clinic, as well as others, have shown that the Copper T(TCu) intrauterine contraceptive device (IUD) is an effective and welltolerated contraceptive method for both nulliparous and multiparous women. 1- 3 In addition to the extensive clinical studies of the TCu 200, various modifications in the amount of copper and its position upon the plastic have been developed and tested clinically. The TCu 300 has approximately 300 mm. 2 copper wire wound around the vertical arm, while the TCu 380A has two 30 mm. 2 copper sleeves placed on the horizontal arm in addition to 300+ mm. 2 copper on the vertical arm. The
disadvantage of the use of copper wire is its relatively short duration of action. Devices with copper wire need to be replaced at intervals of about three years. To overcome this disadvantage, the International Committee for Contraception Research of The Popula'ion Council devised a new modification of the TCu, the Copper T 220C. This device has five solid copper sleeves on the vertical arm, as well as two copper sleeves on the horizontal arm of the T-shaped plastic device for a total of seven sleeves with a surface area of 220 mm. 2 and an estimated duration of effectiveness of more than 20 years. In order to compare the performance of this long-lasting copper IUD with the wire-wound model, a randomized comparative study of the TCu 220C and the TCu 300 was performed.
MANY REPORTS FROM
From the Department of Obstetrics and Gynecology, University of Southern California School of Medicine, and Women's Hospital, Los Angeles County/University of Southern California Medical Center.
Material and methods
This study was undertaken as part of the Contraceptive Development Program of the International Committee for Contraception Research of the Population Council, New York, New York.
Between January and July, 1973, 999 TCu devices were inserted into all women attending the Family Planning Clinic of Women's Hospital who were willing to use an investigational IUD and were able to return for follow-up. The device to be inserted was chosen on the basis of the last digit of the patient's previously assigned hospital number. Patients with odd numbers
Received for publication january 3, 1975. Accepted january 29, 1975. Reprint requests: Dr. Daniel R. Mishell, Jr., Department of Obstetrics and Gynecology, Women's Hospital, 1240 North Mission Road, Los Angeles, California 90033.
121
122 Cooper, Millen, and Mishell
Janllary 15, l9if'
Am.
Table I. Mean and range of various aspects of total cohort data of two groups
J.
Obstet. Cmecol.
Table III. Mean and range of various aspects of cohort data of multiparous women in two groups
Data
TCu 300
TCu 220C
Data
TCu 300
TCu 220C
Number inserted Age Gravidity Parity Nulliparous women
516 23.1 (14-42) 1.05 (0-9) 0.55 (0-9) 363 (70.3%)
483 22.7 (15-45) 1.20 (0-6) 0.48 (0-5) 337 (69.8%)
Number inserted Age Gravidity Parity
153 25.1 (15-42) 2.3 (1-9) 1.9 (1-9)
146 24.1 (15-45) 2.0 (1-6) 1.6 (l-5)
Table II. Mean and range of cohort data of nulliparous women in two groups Data
TCu 300
TCu 220C
Number inserted Age Gravidity Parity
363 22.3 ( 14-40) 0.38 (0-6) 0
334 22.2 (15-39) 0.34 (0-3) 0
received a TCu 220C. Those with even numbers received a TCu 300. A total of 463 women received the 220C and 516 the 300. All devices were inserted by family planning clinic staff physicians with the use of a modified loop inserter and push-in technique. 4 As would be expected from this randomization, the populations using each device were similar in age, gravidity, parity, and per cent of nulliparous women (Table I). Separate analysis of nulliparous women and multiparous women separately also revealed that the groups using each device were comparable (Tables II and III). Event rates during the first 12 months' experience were calculated by life-table analysis with a computer program. 5 Results
There was no difference noted in ease of insertion or postinsertion pain between the two devices. First segment net cumulative termination rates for the first year of use for each device are summarized for all patients in Table IV, for nulliparous patients in Table V, and for multiparous patients in Table VI. For each event rate, the 95 per cent confidence intervals of the standard error of the mean overlapped, indicating no significant difference between the two devices. The pregnancy rates at one year were about one per cent for each device. Pregnancy rates were slightly though not significantly higher among multiparous women. About 70 per cent of the nulliparous patients had never been pregnant, and a certain percentage of these women were probably infertile. Expulsion rates at one year were less than 4.0 per 100 women in both groups with little difference between devices or between nulliparous and multipar-
ous women. The rate of removals for pain and/or bleeding was higher for the TCu 220C than for the TCu 300, but the difference was not significant. Rates of removals for other medical reasons, planned pregnancy, and other personal reasons were also similar for the two devices. Over-all continuation rates at the end of one year were also similar for both devices, with rates of 79.7 and 74.9 per 100 users calculated for the TCu 300 and TCu220C, respectiveiy. This difference in continuation rates was also not significant.
Comment The major disadvantage of the Copper T with wire winding is the need for periodic replacement. This arises because the copper undergoes gradual dissolution in an uneven manner so that breaks in the copper wire can occur. The TCu 220C was developed to overcome this disadvantage. By substituting sleeves for wire, a much greater effective reservior of copper is achieved and the possibility of wire breakage is obviated. The TCu 220C also includes copper sleeves on the horizontal arms, which decreases the chance of fundal pregnancy because of the presence of copper in that area. This is especially important when there is downward displacement or partial expulsion of the device~
The TCu 200 device has been estimated to lose between 25 and 50J..tg per day of copper, 6 and Tatum 7 has recommended that these devices be replaced at three-year intervals based on the actual amount of copper remaining on the device and the continued contraceptive effectiveness at two years. By substituting sleeves for wire and assuming the rate of release of copper is similar per unit surface area for both sleeves and wire, the copper on the TCu 220C is estimated to last more than 20 years. This clinical trial has shown that enough copper is released to maintain comparable contraceptive effectiveness at least through the first year. The Copper T has already been shown to have two major advantages in comparison with other plastic IUD's: (1) The TCu is easier to insert and better
Copper T 220C
Volume 124 Number 2
123
Table IV. Net event rates per 100 women at one year Rates Event Pregnancy Expulsions Removals Pain/bleeding Other medical Planned pregnancy Other personal All causes Continuation Number enrolled Woman months Lost to follow-up
TCu JOO 1.1 (0.3-2.4) 3.1 ( 1.5-4.6)
9.3 2.1 2.7 2.1 20.3 79.7 516 5,205 9%
(6.7-12.0) (1.0-3.8) (1.2-4.2) ( 1.0-3.8) (16.7-24.0)
TCu 220C
0.9 (0.2-2.2) 3.7 (1.9-5.5) 14.4 (11.1-17.7) 0.9 (0.2-2.2) 3.1 (1.5-4.7) 2.2 (1.1-4.0) 25.1 (21.1-29.2) 74.9 483 4,775 7%
Table V. Net event rates at one year for nulliparous women Rates Event Pregnancy Expulsions Removals Pain/bleeding Other medical Planned pregnancy Other personal All causes Continuation Number enrolled Woman months Lost to follow-up
TCu JOO
TCu 220C
0.9 (0.2-2.6) 3.1 (1.3-5.0)
0.6 (0.1-2.2) 4.0 (1.8-6.2)
9.6 2.4 2.4 2.3 20.8 79.2 363 3,650 8%
(6.4-12.8) (1.1-4.7) (1.1-4.7) (1.0-4.6) (16.4-25.2)
12.7 0.9 2.8 2.2 23.3 76.7 337 3,397 5%
(9.0-16.4) (0.2-2.7) (1.3-5.3) (0.9-4.5) (18.5-28.0)
Table VI. Net event rates at one year for multiparous women Rates Event Pregnancy Expulsions Removals Pain/bleeding Other medical Planned pregnancy Other personal All causes Continuation Number enrolled Woman months Lost to follow-up
TCu JOO
TCu 220C
1.4 (0.2-5.2) 2.8 (0.8-7 .2)
1.5 (0.2-5.3) 3.0 (0.8-7.5)
8.6 (3.8-13.3) 1.4 (0.2-5.1) 3.6 (1.3-8.2) 1.4 (0.2-5.1) 19.2 (12.6-25.9) 80.8 153 1,556 10%
tolerated by nulliparous women. 8 (2) There is less menstrual blood loss in both nulliparous and multiparous women with the copper devices. 9 The major disadvantage has been the need for periodic replacement, which is not necessary for the plastic devices. The results of this randomized study indicate that the TCu 220C, which is not expected to have this disadvantage, has event rates similar to those of the
18.4 (11.8-25.1) 0.7 (0.02-4.0) 3. 7 ( 1.2-8. 7) 2.3 (0.5-6.7) 29.6 (21.7-37.4) 70.4 146 1,348 10%
wire-wound TCu 300 in the first year of use. If long-term follow-up confirms these findings, the TCu 220C could become the IUD of choice for all women. We acknowledge the contribution of James Winter, M.D., in developing the computer program used for life-table analysis. The assistance of Harlene Breaux and Marie Fielding is also gratefully acknowledged.
124 Cooper, Millen, and Mishell
Januan l'i, lll71i
Alll.
J. Obstet.
GH1eml.
REFERENCES I. Mishell, D. R.,Jr., Israel, R., and Fried, N.: A study of the copper-T (TCu 200) intrauterine contraceptive device in nulliparous women, AM. J. 0BsTET. GYNECOL. 116: 1092, 1973. 2. Roy, S., Cooper, D., and Mishell, D. R., Jr.: Experience with three different models of the copper-T intrauterine device in nulliparous women, AM. J. 0BSTET. GYNECOL 119: 414, 1974. 3. Cooper, D., Israel, R., and Mishell, D. R., Jr.: A randomized comparative study of the copper T 300, Dalkon shield, and Shell loop in parous women, Obstet. Gynecol. 45: 569, 1975. 4. Cooper, D.: Improved insertion techniques for copper intrauterine devices, Contraception. In press. 5. Cooper, D., and Winter, J.: Life table analysis of the
etfectiveness of contraceptive devices using an API. computer program, Contraception. In press. 6. Hagenfeldt, K.: Intrauterine contraception with the copper T device. I. Effect on trace elements in the endometrium, cervical mucus, and plasma, Contraception 6: 37. 1972.
7. Tatum, H.J.: Metallic copper as an intrauterine contraceptive agent, AM. J. 0BSTET. GYNECOL. 117: 602, 1973. 8. Israel, R., Shaw, S. T., Jr., and Martin, M.: Comparative quantitation of menstrual blood loss with the Lippes loop. Dalkon shield, and Copper T intrauterine devices, Contraception 9: 63, 1974. 9. Hefnawi, F., Askalani, H., and Zaki, K.: Menstrual blood loss with copper intrauterine devices, Contraception 9: 133, 1974.
The Copper T(TCu) intrauterine contraceptive device (IUD) has been found to be an effective method of contraception but has the disadvantage of needing periodic replacement due to loss of copper through dissolution and fragmentation of the copper wire. Modification of the Copper T to overcome this disadvantage involved substitution of copper sleeves for wire on the vertical arm and the addition of copper sleeves to the horizontal arms to give an effective surface area of 220 sq. mm. of copper and an estimated life span of 20 years. A randomized comparative study was undertaken in 999 women to determine if the new model performed as well as the wire-wound Copper T 300. Net cumulative first-event rates at one year were as follows: TCu 220C-pregnancy 0.9, expulsion 3.7, removal for pain or bleeding 14.4; TCu 300-pregnancy 1.1, expulsion 3.1, removal for pain or bleeding 9.3. None of the differences in event rates were significant. If long-term follow-up confirms these findings, this new long-lasting copper intrauterine device could become the IUD of choice for all women.
this clinic, as well as others, have shown that the Copper T(TCu) intrauterine contraceptive device (IUD) is an effective and welltolerated contraceptive method for both nulliparous and multiparous women. 1- 3 In addition to the extensive clinical studies of the TCu 200, various modifications in the amount of copper and its position upon the plastic have been developed and tested clinically. The TCu 300 has approximately 300 mm. 2 copper wire wound around the vertical arm, while the TCu 380A has two 30 mm. 2 copper sleeves placed on the horizontal arm in addition to 300+ mm. 2 copper on the vertical arm. The
disadvantage of the use of copper wire is its relatively short duration of action. Devices with copper wire need to be replaced at intervals of about three years. To overcome this disadvantage, the International Committee for Contraception Research of The Popula'ion Council devised a new modification of the TCu, the Copper T 220C. This device has five solid copper sleeves on the vertical arm, as well as two copper sleeves on the horizontal arm of the T-shaped plastic device for a total of seven sleeves with a surface area of 220 mm. 2 and an estimated duration of effectiveness of more than 20 years. In order to compare the performance of this long-lasting copper IUD with the wire-wound model, a randomized comparative study of the TCu 220C and the TCu 300 was performed.
MANY REPORTS FROM
From the Department of Obstetrics and Gynecology, University of Southern California School of Medicine, and Women's Hospital, Los Angeles County/University of Southern California Medical Center.
Material and methods
This study was undertaken as part of the Contraceptive Development Program of the International Committee for Contraception Research of the Population Council, New York, New York.
Between January and July, 1973, 999 TCu devices were inserted into all women attending the Family Planning Clinic of Women's Hospital who were willing to use an investigational IUD and were able to return for follow-up. The device to be inserted was chosen on the basis of the last digit of the patient's previously assigned hospital number. Patients with odd numbers
Received for publication january 3, 1975. Accepted january 29, 1975. Reprint requests: Dr. Daniel R. Mishell, Jr., Department of Obstetrics and Gynecology, Women's Hospital, 1240 North Mission Road, Los Angeles, California 90033.
121
122 Cooper, Millen, and Mishell
Janllary 15, l9if'
Am.
Table I. Mean and range of various aspects of total cohort data of two groups
J.
Obstet. Cmecol.
Table III. Mean and range of various aspects of cohort data of multiparous women in two groups
Data
TCu 300
TCu 220C
Data
TCu 300
TCu 220C
Number inserted Age Gravidity Parity Nulliparous women
516 23.1 (14-42) 1.05 (0-9) 0.55 (0-9) 363 (70.3%)
483 22.7 (15-45) 1.20 (0-6) 0.48 (0-5) 337 (69.8%)
Number inserted Age Gravidity Parity
153 25.1 (15-42) 2.3 (1-9) 1.9 (1-9)
146 24.1 (15-45) 2.0 (1-6) 1.6 (l-5)
Table II. Mean and range of cohort data of nulliparous women in two groups Data
TCu 300
TCu 220C
Number inserted Age Gravidity Parity
363 22.3 ( 14-40) 0.38 (0-6) 0
334 22.2 (15-39) 0.34 (0-3) 0
received a TCu 220C. Those with even numbers received a TCu 300. A total of 463 women received the 220C and 516 the 300. All devices were inserted by family planning clinic staff physicians with the use of a modified loop inserter and push-in technique. 4 As would be expected from this randomization, the populations using each device were similar in age, gravidity, parity, and per cent of nulliparous women (Table I). Separate analysis of nulliparous women and multiparous women separately also revealed that the groups using each device were comparable (Tables II and III). Event rates during the first 12 months' experience were calculated by life-table analysis with a computer program. 5 Results
There was no difference noted in ease of insertion or postinsertion pain between the two devices. First segment net cumulative termination rates for the first year of use for each device are summarized for all patients in Table IV, for nulliparous patients in Table V, and for multiparous patients in Table VI. For each event rate, the 95 per cent confidence intervals of the standard error of the mean overlapped, indicating no significant difference between the two devices. The pregnancy rates at one year were about one per cent for each device. Pregnancy rates were slightly though not significantly higher among multiparous women. About 70 per cent of the nulliparous patients had never been pregnant, and a certain percentage of these women were probably infertile. Expulsion rates at one year were less than 4.0 per 100 women in both groups with little difference between devices or between nulliparous and multipar-
ous women. The rate of removals for pain and/or bleeding was higher for the TCu 220C than for the TCu 300, but the difference was not significant. Rates of removals for other medical reasons, planned pregnancy, and other personal reasons were also similar for the two devices. Over-all continuation rates at the end of one year were also similar for both devices, with rates of 79.7 and 74.9 per 100 users calculated for the TCu 300 and TCu220C, respectiveiy. This difference in continuation rates was also not significant.
Comment The major disadvantage of the Copper T with wire winding is the need for periodic replacement. This arises because the copper undergoes gradual dissolution in an uneven manner so that breaks in the copper wire can occur. The TCu 220C was developed to overcome this disadvantage. By substituting sleeves for wire, a much greater effective reservior of copper is achieved and the possibility of wire breakage is obviated. The TCu 220C also includes copper sleeves on the horizontal arms, which decreases the chance of fundal pregnancy because of the presence of copper in that area. This is especially important when there is downward displacement or partial expulsion of the device~
The TCu 200 device has been estimated to lose between 25 and 50J..tg per day of copper, 6 and Tatum 7 has recommended that these devices be replaced at three-year intervals based on the actual amount of copper remaining on the device and the continued contraceptive effectiveness at two years. By substituting sleeves for wire and assuming the rate of release of copper is similar per unit surface area for both sleeves and wire, the copper on the TCu 220C is estimated to last more than 20 years. This clinical trial has shown that enough copper is released to maintain comparable contraceptive effectiveness at least through the first year. The Copper T has already been shown to have two major advantages in comparison with other plastic IUD's: (1) The TCu is easier to insert and better
Copper T 220C
Volume 124 Number 2
123
Table IV. Net event rates per 100 women at one year Rates Event Pregnancy Expulsions Removals Pain/bleeding Other medical Planned pregnancy Other personal All causes Continuation Number enrolled Woman months Lost to follow-up
TCu JOO 1.1 (0.3-2.4) 3.1 ( 1.5-4.6)
9.3 2.1 2.7 2.1 20.3 79.7 516 5,205 9%
(6.7-12.0) (1.0-3.8) (1.2-4.2) ( 1.0-3.8) (16.7-24.0)
TCu 220C
0.9 (0.2-2.2) 3.7 (1.9-5.5) 14.4 (11.1-17.7) 0.9 (0.2-2.2) 3.1 (1.5-4.7) 2.2 (1.1-4.0) 25.1 (21.1-29.2) 74.9 483 4,775 7%
Table V. Net event rates at one year for nulliparous women Rates Event Pregnancy Expulsions Removals Pain/bleeding Other medical Planned pregnancy Other personal All causes Continuation Number enrolled Woman months Lost to follow-up
TCu JOO
TCu 220C
0.9 (0.2-2.6) 3.1 (1.3-5.0)
0.6 (0.1-2.2) 4.0 (1.8-6.2)
9.6 2.4 2.4 2.3 20.8 79.2 363 3,650 8%
(6.4-12.8) (1.1-4.7) (1.1-4.7) (1.0-4.6) (16.4-25.2)
12.7 0.9 2.8 2.2 23.3 76.7 337 3,397 5%
(9.0-16.4) (0.2-2.7) (1.3-5.3) (0.9-4.5) (18.5-28.0)
Table VI. Net event rates at one year for multiparous women Rates Event Pregnancy Expulsions Removals Pain/bleeding Other medical Planned pregnancy Other personal All causes Continuation Number enrolled Woman months Lost to follow-up
TCu JOO
TCu 220C
1.4 (0.2-5.2) 2.8 (0.8-7 .2)
1.5 (0.2-5.3) 3.0 (0.8-7.5)
8.6 (3.8-13.3) 1.4 (0.2-5.1) 3.6 (1.3-8.2) 1.4 (0.2-5.1) 19.2 (12.6-25.9) 80.8 153 1,556 10%
tolerated by nulliparous women. 8 (2) There is less menstrual blood loss in both nulliparous and multiparous women with the copper devices. 9 The major disadvantage has been the need for periodic replacement, which is not necessary for the plastic devices. The results of this randomized study indicate that the TCu 220C, which is not expected to have this disadvantage, has event rates similar to those of the
18.4 (11.8-25.1) 0.7 (0.02-4.0) 3. 7 ( 1.2-8. 7) 2.3 (0.5-6.7) 29.6 (21.7-37.4) 70.4 146 1,348 10%
wire-wound TCu 300 in the first year of use. If long-term follow-up confirms these findings, the TCu 220C could become the IUD of choice for all women. We acknowledge the contribution of James Winter, M.D., in developing the computer program used for life-table analysis. The assistance of Harlene Breaux and Marie Fielding is also gratefully acknowledged.
124 Cooper, Millen, and Mishell
Januan l'i, lll71i
Alll.
J. Obstet.
GH1eml.
REFERENCES I. Mishell, D. R.,Jr., Israel, R., and Fried, N.: A study of the copper-T (TCu 200) intrauterine contraceptive device in nulliparous women, AM. J. 0BsTET. GYNECOL. 116: 1092, 1973. 2. Roy, S., Cooper, D., and Mishell, D. R., Jr.: Experience with three different models of the copper-T intrauterine device in nulliparous women, AM. J. 0BSTET. GYNECOL 119: 414, 1974. 3. Cooper, D., Israel, R., and Mishell, D. R., Jr.: A randomized comparative study of the copper T 300, Dalkon shield, and Shell loop in parous women, Obstet. Gynecol. 45: 569, 1975. 4. Cooper, D.: Improved insertion techniques for copper intrauterine devices, Contraception. In press. 5. Cooper, D., and Winter, J.: Life table analysis of the
etfectiveness of contraceptive devices using an API. computer program, Contraception. In press. 6. Hagenfeldt, K.: Intrauterine contraception with the copper T device. I. Effect on trace elements in the endometrium, cervical mucus, and plasma, Contraception 6: 37. 1972.
7. Tatum, H.J.: Metallic copper as an intrauterine contraceptive agent, AM. J. 0BSTET. GYNECOL. 117: 602, 1973. 8. Israel, R., Shaw, S. T., Jr., and Martin, M.: Comparative quantitation of menstrual blood loss with the Lippes loop. Dalkon shield, and Copper T intrauterine devices, Contraception 9: 63, 1974. 9. Hefnawi, F., Askalani, H., and Zaki, K.: Menstrual blood loss with copper intrauterine devices, Contraception 9: 133, 1974.
