CONTRACEPTION
FIVE YEARS EXPERIENCE OF INTRAUTERINE CONTRACEPTION WITH THE NOVA-T
Pierre Fugere, M.D., FRCS(C), FACOG, Department of Obstetrics and Gynecology University of Montreal, Hapita Saint-Luc 1058 Saint-Denis, Montreal, Quebec, Canada H2X 354
ABSTRACT
This study was conducted to evaluate the clinical performance of the Nova-T IUD. The insertion period was from November 1981 to November 1982. Two-hundred-and-one (201) consecutive IUDs were inserted in women attending a family planning clinic and they were followed for a period of 5 years. Most events occurred in the first 2 years of the study and there were no pregnancies in the 3rd, 4th or 5th year. The pregnancy rate after 5 years was 3.2 or a Pearl index of 1.21 which is very good compared to other methods of contraception now available. Our conclusion is that the Nova-T IUD is an excellent method of contraception and it can be left in place for a period of 5 years.
Submitted for publication July 28, 1989 Accepted for publication September 25, 1989
JANUARY
1990 VOL. 41 NO. 1
1
CONTRACEPTION
INTRODUCTION
The intrauterine contraceptive devices (IlIDs)have not gained wide acceptance in Canada and in the U.S. Only 6 to 7% of women of reproductive age use the IUD compared to 25% in Scandinavian countries, and 35% in China (1). The physicians are reluctant to use the intrauterine contraceptive devices because they are not convinced of the high degree of efficacy of this contraceptive method and they still are afraid of being responsible for a pelvic infection and its sequelae. The medico-legal issues in the U.S. has also tempered its use in Canada. Some recent papers have tried to circumscribe the problem of infection with the IUD and have come to the conclusion that the use of a Copper IUD coupled with a stable relationshipdoes not cause an increase in tubal infertility (2). For these reasons, many women have not been offered this method of contraception; this could partially be responsible for an increase in abortions and an increase in early tubal sterilizations. We thought it would be of interest to present our 5-year experience with the Nova-T IUD. The Health Protection Branch in Canada has recommended removal of the IUDs after 24 to 30 months because in their experience with the Copper-7 IUD or the Copper T-200. There quite often was a disintegration of the copper, and presence of calcifications after two years in utero.
MATERIAL AND METHODS The Nova-T IUD has a surface area of 200 mm2 of copper, and it has a silver core which prevents fragmentation of the wire. For this reason, it has been estimated to be effective for at least 5 years in situ (3). Two-hundred-and-one (201) consecutive women attending a family planning clinic at a university hospital, from November 1981 to November 1982. were recruited to participate in this study. They were informed of the possibility of using the IUD for 5years and signed an informed consent. The insertion of the IUD and the follow-up were carried out mainly by the residents under the supervision of a gynecologist.
JANUARY
199OVOL. 41 NO. 1
CONTRACEPTION
The age and parity distribution and the mean age are given in Table I. The cut-off date was the first day of the last menstruation reported at the 5-year control visit. All statistical analyses were performed by the life-table method of Potter with the use of a digital program.
TABLE I AGE AND PARITY
Age:
Mean 28.2 Range 17-42
< 20
Parity
No.
3
0
54
20-24
43
1
65
25-30
83
2
44
31-34
50
3
38
> 35
22
Total
JANUARY
No.
1990VOL. 41 NO. 1
201
201
3
CONTRACEPTION
RESULTS
Table II gives the number of events per year, the net rates per 100 acceptors per year, the Pearl index and the number of women lost to follow-up during the 5-year study period. There were 2 accidental pregnancies in the first year, and 4 in the second year, and none in the last 3 years of follow-up. The main reason for removal of the IUD was bleeding and pain for a total of 51 removals in 5 years, or a net rate of 27.3. The IUD was removed for infection in 9 patients or a net rate of 4.8 after 5 years, and only 2 of these patients met all the criteria for acute salpingitis, and 7 other IUDs were removed because of a suspicion of infection rather than a definite diagnosis of salpingitis. One of the women with salpingitis had gonorrhea identified. During the 5 years, only 17 women were considered as lost to follow-up. The number of woman-months at 5 years was 5,970 with a Pearl index of 1.21.
TABLE II
CUMULATIVE NUMBER OF EVENTS PER YEAR AND NET RATES PER 100 ACCEPTORS PER YEAR
Year
1 E.:N.R.
2 E.:N.R.
3
4
E.:N.R.
E.:N.R.
5 E.:N.R.
Pregnancy 2 : 1.1 6 : 3.2 6 : 3.2 6 : 3.2 6 : 3.2 Expulsion 3 : 1.6 4 : 2.1 4 : 2.1 4 : 2.1 4 : 2.1 Removals Bleeding & pain 24 k2.7 30 :16 41 i22.3 47 i25.3 51 i27.3 Infection 5 : 2.7 7 : 3.7 a : 4.3 a : 4.3 : 4.8 Other medical 0: 0 1: .5 3 : 1.8 6 : 3.3 10 : 5.5 Plan. pregnancy a : 4.3 13 : 7.0 21 :11.5 22 :11.9 26 :14.1 Other personal 8 : 4.2 21 :11.3 24 :13 27 :14.6 28 :15 No. entering : : 1st mt. 201 : 201 : 201 : 201 : 201 : No completing : last mt. 136 : 101 : 67 : 60 : 47 : Woman-months 1940 : 3364 : 4364 : 5276 : 5970 : Related termination 50 i26.5 82 i43.9 107 i58.3 134 i64.7 134 i72 Pearl Index 1.24 : 2.14 : 1.65 : .36 : 1.21 : Lost to follow-up : 17 :
E.: Events
4
N.R. :
Net rates
JANUARY
1990VOL. 41 NO. 1
CONTRACEPTION
Since all the pregnancies occurred in the first 24 months, the pregnancy rates and the removal rates by age and parity for the first 24 months were studied (Table III). Most of the pregnancies occurred in women who were multiparous, but less than 25 years old. The expulsion rate was more frequent in women less than 25 years old for a rate of 4.9, while the removal for bleeding and pain was the same for both groups. The infection rate is much higher in the group less than 25 years old, with the rate of 10.4 compared to 0.8 for women over 25 years old.
TABLE
III
THE 24-MONTH BATE OF EVENTS PER 100 WOMEN BY AGE AND PARITY
Less than 25 years old (67 cases)
Over 25 years old (134 cases)
Pregnancy
5.3
2.4
Expulsion
4.9
0.8
Bleeding and pain
18.7
14.3
Infection
10.4
0.8
Nulliparous (54 cases)
Multiparous (147 cases)
Pregnancy
0.0
4.6
Expulsion
1.9
2.2
17.2
15.1
5.8
3.0
Bleeding and pain Infection
JANUARY
1990 VOL. 41 NO. 1
5
CONTRACEPTION
Because of the fear that the use of IUDs for 5 years or more could be responsible for chronic infections in the endometrium or the endosalpinx, endocervical cultures on the last 49 patients at removal of their IUD after 5 years of use were taken. Thirty (30) patients who came in for insertion of IUDwereused as the control group. A specimen from the endocervical canal was sent to the microbiology lab for cultures for ureaplasma, mycoplasma, chlamydia, gonorrhea and actinomyces. There was no difference in ureaplasma and mycoplasma in the 2 groups, while 2 of the new patients had chlamydia, and 1 case of actinomyces in a woman using the IUD for 5 years was found (Table IV). All the IUDs removed (119) during the study and those removed after 5 years (49) were examined with a microscope and none presented any break of the copper wire.
DISCUSSION The results of the study demonstrate very good contraceptive efficacy with a Pearl index at 5 years of 1.21. In the study, all the accidental pregnancies occurred during the first 2 years of use and efficacy was 100% for the last 3 years of the study. Removals were much higher during the first 2 years than during the last 3 years.
TABLE IV
ENDOCERVICAL CULTURES OF THE 49 PATIENTS AT THE REMOVAL OF THEIR NOVA-T AFTER 5 YEARS OF USE COMPARED TO A CONTROL GROUP
NOVA-T (49 patients)
Control Group (30 patients)
Ureaplasma
22
(44.9%)
14
(46.7%)
Mycoplasma
8
(16.3%)
3
(10.0%)
Chlamydia
0
(0.0%)
2
(6.7%)
Gonorrhea
0
(0.0%)
0
(0.0%)
Actinomyces
1
(2.0%)
0
(0.0%)
JANUARY
1990 VOL. 41 NO. 1
CONTRACEPTION
Most of the removals for infection were during the first 2 years of use (7 out of 9>, and after 5 years, no chronic infection could be identfied by endocervical cultures except 1 case of actinomyces. There is no indication to remove the Nova-T IUD after 21 to 3 years as is recommended by the Health Protection Branch in Canada since with the Nova-T, fragmentation is eliminated because the copper wire has a silver core which increases its life to 5 years or more. The return of fertility was studied by Pyorala et al. (4) in women who requested removal of the devicebecause of planning pregnancy. The results revealed that fertility was not affected by the use of the the Nova-T and the return of fertility was similar in women who had used these devices for more than 2 years when compared to less than 2 years of use. If the usual criteria for the use of IUD is followed, i.e., women over 25, ideally multiparous and with a stable relationship, the fear of infection is not higher than with any other type of contraception. The results of this study show that the life-table pregnancy rate and the Pearl index for the Nova-T users during 5 years of use are very low and represent a most effective contraceptive method for these women. The Nova-T IUD could be left in situ for a 5-year duration instead of the 3 years which is recommended presently.
REFERENCES
1.
Population Reports. IUDs: An appropriate contraceptive for many women. Series B, No.4, July 1982.
2.
Cramer DW, Schiff I, Schoenbaum SC, et al. Tubal infertility and the intrauterine device. New Engl J of Med 1985; 312(15):941-947.
3.
Luukkainen T, Allonen H, Nielsen N-C, Mygren K-G, Pyorala T. Five years experience of intrauterine contraception with the Nova-T and the Copper-T-200. Am J Obst Gyn 1983; 885-892.
4.
Pyorala T, Allonen H, Nygren K-G, Nielsen N-C, Luukkainen T. Return of fertility after the removal of Nova-T or Copper-T-200. Contraception 1982; 26:113.
JANUARY
1990 VOL. 41 NO. 1
FIVE YEARS EXPERIENCE OF INTRAUTERINE CONTRACEPTION WITH THE NOVA-T
Pierre Fugere, M.D., FRCS(C), FACOG, Department of Obstetrics and Gynecology University of Montreal, Hapita Saint-Luc 1058 Saint-Denis, Montreal, Quebec, Canada H2X 354
ABSTRACT
This study was conducted to evaluate the clinical performance of the Nova-T IUD. The insertion period was from November 1981 to November 1982. Two-hundred-and-one (201) consecutive IUDs were inserted in women attending a family planning clinic and they were followed for a period of 5 years. Most events occurred in the first 2 years of the study and there were no pregnancies in the 3rd, 4th or 5th year. The pregnancy rate after 5 years was 3.2 or a Pearl index of 1.21 which is very good compared to other methods of contraception now available. Our conclusion is that the Nova-T IUD is an excellent method of contraception and it can be left in place for a period of 5 years.
Submitted for publication July 28, 1989 Accepted for publication September 25, 1989
JANUARY
1990 VOL. 41 NO. 1
1
CONTRACEPTION
INTRODUCTION
The intrauterine contraceptive devices (IlIDs)have not gained wide acceptance in Canada and in the U.S. Only 6 to 7% of women of reproductive age use the IUD compared to 25% in Scandinavian countries, and 35% in China (1). The physicians are reluctant to use the intrauterine contraceptive devices because they are not convinced of the high degree of efficacy of this contraceptive method and they still are afraid of being responsible for a pelvic infection and its sequelae. The medico-legal issues in the U.S. has also tempered its use in Canada. Some recent papers have tried to circumscribe the problem of infection with the IUD and have come to the conclusion that the use of a Copper IUD coupled with a stable relationshipdoes not cause an increase in tubal infertility (2). For these reasons, many women have not been offered this method of contraception; this could partially be responsible for an increase in abortions and an increase in early tubal sterilizations. We thought it would be of interest to present our 5-year experience with the Nova-T IUD. The Health Protection Branch in Canada has recommended removal of the IUDs after 24 to 30 months because in their experience with the Copper-7 IUD or the Copper T-200. There quite often was a disintegration of the copper, and presence of calcifications after two years in utero.
MATERIAL AND METHODS The Nova-T IUD has a surface area of 200 mm2 of copper, and it has a silver core which prevents fragmentation of the wire. For this reason, it has been estimated to be effective for at least 5 years in situ (3). Two-hundred-and-one (201) consecutive women attending a family planning clinic at a university hospital, from November 1981 to November 1982. were recruited to participate in this study. They were informed of the possibility of using the IUD for 5years and signed an informed consent. The insertion of the IUD and the follow-up were carried out mainly by the residents under the supervision of a gynecologist.
JANUARY
199OVOL. 41 NO. 1
CONTRACEPTION
The age and parity distribution and the mean age are given in Table I. The cut-off date was the first day of the last menstruation reported at the 5-year control visit. All statistical analyses were performed by the life-table method of Potter with the use of a digital program.
TABLE I AGE AND PARITY
Age:
Mean 28.2 Range 17-42
< 20
Parity
No.
3
0
54
20-24
43
1
65
25-30
83
2
44
31-34
50
3
38
> 35
22
Total
JANUARY
No.
1990VOL. 41 NO. 1
201
201
3
CONTRACEPTION
RESULTS
Table II gives the number of events per year, the net rates per 100 acceptors per year, the Pearl index and the number of women lost to follow-up during the 5-year study period. There were 2 accidental pregnancies in the first year, and 4 in the second year, and none in the last 3 years of follow-up. The main reason for removal of the IUD was bleeding and pain for a total of 51 removals in 5 years, or a net rate of 27.3. The IUD was removed for infection in 9 patients or a net rate of 4.8 after 5 years, and only 2 of these patients met all the criteria for acute salpingitis, and 7 other IUDs were removed because of a suspicion of infection rather than a definite diagnosis of salpingitis. One of the women with salpingitis had gonorrhea identified. During the 5 years, only 17 women were considered as lost to follow-up. The number of woman-months at 5 years was 5,970 with a Pearl index of 1.21.
TABLE II
CUMULATIVE NUMBER OF EVENTS PER YEAR AND NET RATES PER 100 ACCEPTORS PER YEAR
Year
1 E.:N.R.
2 E.:N.R.
3
4
E.:N.R.
E.:N.R.
5 E.:N.R.
Pregnancy 2 : 1.1 6 : 3.2 6 : 3.2 6 : 3.2 6 : 3.2 Expulsion 3 : 1.6 4 : 2.1 4 : 2.1 4 : 2.1 4 : 2.1 Removals Bleeding & pain 24 k2.7 30 :16 41 i22.3 47 i25.3 51 i27.3 Infection 5 : 2.7 7 : 3.7 a : 4.3 a : 4.3 : 4.8 Other medical 0: 0 1: .5 3 : 1.8 6 : 3.3 10 : 5.5 Plan. pregnancy a : 4.3 13 : 7.0 21 :11.5 22 :11.9 26 :14.1 Other personal 8 : 4.2 21 :11.3 24 :13 27 :14.6 28 :15 No. entering : : 1st mt. 201 : 201 : 201 : 201 : 201 : No completing : last mt. 136 : 101 : 67 : 60 : 47 : Woman-months 1940 : 3364 : 4364 : 5276 : 5970 : Related termination 50 i26.5 82 i43.9 107 i58.3 134 i64.7 134 i72 Pearl Index 1.24 : 2.14 : 1.65 : .36 : 1.21 : Lost to follow-up : 17 :
E.: Events
4
N.R. :
Net rates
JANUARY
1990VOL. 41 NO. 1
CONTRACEPTION
Since all the pregnancies occurred in the first 24 months, the pregnancy rates and the removal rates by age and parity for the first 24 months were studied (Table III). Most of the pregnancies occurred in women who were multiparous, but less than 25 years old. The expulsion rate was more frequent in women less than 25 years old for a rate of 4.9, while the removal for bleeding and pain was the same for both groups. The infection rate is much higher in the group less than 25 years old, with the rate of 10.4 compared to 0.8 for women over 25 years old.
TABLE
III
THE 24-MONTH BATE OF EVENTS PER 100 WOMEN BY AGE AND PARITY
Less than 25 years old (67 cases)
Over 25 years old (134 cases)
Pregnancy
5.3
2.4
Expulsion
4.9
0.8
Bleeding and pain
18.7
14.3
Infection
10.4
0.8
Nulliparous (54 cases)
Multiparous (147 cases)
Pregnancy
0.0
4.6
Expulsion
1.9
2.2
17.2
15.1
5.8
3.0
Bleeding and pain Infection
JANUARY
1990 VOL. 41 NO. 1
5
CONTRACEPTION
Because of the fear that the use of IUDs for 5 years or more could be responsible for chronic infections in the endometrium or the endosalpinx, endocervical cultures on the last 49 patients at removal of their IUD after 5 years of use were taken. Thirty (30) patients who came in for insertion of IUDwereused as the control group. A specimen from the endocervical canal was sent to the microbiology lab for cultures for ureaplasma, mycoplasma, chlamydia, gonorrhea and actinomyces. There was no difference in ureaplasma and mycoplasma in the 2 groups, while 2 of the new patients had chlamydia, and 1 case of actinomyces in a woman using the IUD for 5 years was found (Table IV). All the IUDs removed (119) during the study and those removed after 5 years (49) were examined with a microscope and none presented any break of the copper wire.
DISCUSSION The results of the study demonstrate very good contraceptive efficacy with a Pearl index at 5 years of 1.21. In the study, all the accidental pregnancies occurred during the first 2 years of use and efficacy was 100% for the last 3 years of the study. Removals were much higher during the first 2 years than during the last 3 years.
TABLE IV
ENDOCERVICAL CULTURES OF THE 49 PATIENTS AT THE REMOVAL OF THEIR NOVA-T AFTER 5 YEARS OF USE COMPARED TO A CONTROL GROUP
NOVA-T (49 patients)
Control Group (30 patients)
Ureaplasma
22
(44.9%)
14
(46.7%)
Mycoplasma
8
(16.3%)
3
(10.0%)
Chlamydia
0
(0.0%)
2
(6.7%)
Gonorrhea
0
(0.0%)
0
(0.0%)
Actinomyces
1
(2.0%)
0
(0.0%)
JANUARY
1990 VOL. 41 NO. 1
CONTRACEPTION
Most of the removals for infection were during the first 2 years of use (7 out of 9>, and after 5 years, no chronic infection could be identfied by endocervical cultures except 1 case of actinomyces. There is no indication to remove the Nova-T IUD after 21 to 3 years as is recommended by the Health Protection Branch in Canada since with the Nova-T, fragmentation is eliminated because the copper wire has a silver core which increases its life to 5 years or more. The return of fertility was studied by Pyorala et al. (4) in women who requested removal of the devicebecause of planning pregnancy. The results revealed that fertility was not affected by the use of the the Nova-T and the return of fertility was similar in women who had used these devices for more than 2 years when compared to less than 2 years of use. If the usual criteria for the use of IUD is followed, i.e., women over 25, ideally multiparous and with a stable relationship, the fear of infection is not higher than with any other type of contraception. The results of this study show that the life-table pregnancy rate and the Pearl index for the Nova-T users during 5 years of use are very low and represent a most effective contraceptive method for these women. The Nova-T IUD could be left in situ for a 5-year duration instead of the 3 years which is recommended presently.
REFERENCES
1.
Population Reports. IUDs: An appropriate contraceptive for many women. Series B, No.4, July 1982.
2.
Cramer DW, Schiff I, Schoenbaum SC, et al. Tubal infertility and the intrauterine device. New Engl J of Med 1985; 312(15):941-947.
3.
Luukkainen T, Allonen H, Nielsen N-C, Mygren K-G, Pyorala T. Five years experience of intrauterine contraception with the Nova-T and the Copper-T-200. Am J Obst Gyn 1983; 885-892.
4.
Pyorala T, Allonen H, Nygren K-G, Nielsen N-C, Luukkainen T. Return of fertility after the removal of Nova-T or Copper-T-200. Contraception 1982; 26:113.
JANUARY
1990 VOL. 41 NO. 1
