A Multi-center Comparison Study
The Scientific Research Institute of Family Planning of Liaoning Province, 110031
Abstract
Objective: To observe the clinical effect and safety of the new type MCu IUD.
Method: According to the unified standard, 1100 cases were selected and inserted with MCu IUD and TCu 380A randomly (each for 550 cases) at six domestic clinical centers. Regular follow-up visits were carried out.
Result: In the 48th month after insertion, the continuous application rates of MCu IUD and TCu 380A IUD were 84.82% and 81.62% respectively (P﹥0.05). The rates of pregnancy with IUD were 1.26% and 1.72% respectively (P﹥0.05). The expulsion rate were 0.42% and 3.45% respectively (P＜0.05). There was significant difference. The removal rates caused by other reasons were 4.19% and 5.82% respectively (P﹥0.05). Complaining women accounted for 3.77% and 7.76% respectively and there was significant difference. P＜0.05. Most women who had planned for pregnancy were pregnant within one year after removal. Conclusion: MCu IUD have some characteristics such as low expulsion rate, better contraceptive effect and easy to remove. It is easy, safe and effective for MCu IUD to be inserted and removed. It is worthy of be recommended to use widely.
Key words: MCu IUD T Cu380A IUD Contrast Clinic Effect
Inserting IUD is a main contraceptive way for women of childbearing age, but the expulsion, pregnancy, side effects, and removal rate due to IUD’s adverse symptoms are still need to be solved due to the influences of the manufacture material, structure design, uterus form, physiological expanding and contraction, etc. The newly designed MCu IUD has some characteristics such as high contraceptive effect, low expulsion rate, slight sight effect and safety, therefore can effectively solve the above problems. In order to further observe the clinic effect and safety of the new type MCu IUD, from February to June of 2001, Scientific Research Institute of Family Planning of Liaoning Province organized six units of five provinces to observe the clinic effect together. They used the advanced study method of randomly sampling and contrasting multi-center clinic to observe the clinic effect of MCu IUD and TCu 380A IUD. The following is the clinical observation report of 48 months.
Data and method:
Ⅰ. Objective
Select women who are 20~40 years old and healthy; have regular menses; do not have the history of ectopic pregnancy and hydatid mole, already have children, the length of the uterus cavity is 6-9cm; live together with her husband and are willing to choose IUD as the only contraceptive way and accept the follow-up visits. They should sign an agreement which specifies the trial. One who does not have any contraindications after check could be the trial woman.
Ⅱ. Study method
From February to June 2001, six Family Planning Service Departments or hospitals selected trial women according to unified standard. The trial women were accepted by six clinical centers and signed the agreement respectively. Special clinical doctors inserted IUDs. The operation followed the contraceptive operation regulation. After operation, the normal recheck were carried out in the 1st, 3rd, 6th, 12th, and 24th month to observe its efficiency, safety and side effects. MCu IUD is manufactured by Liaoning AiMu (former name Anshan Baojie ) Medical Science and Technology Co., Ltd.. The copper surface area of it is 120mm2 . It is inserted by means of withdrawal. Extractor is used to take it out. We used the world admitted well-effect TCu380A IUD as the contrast, which is manufactured by Siping Medical Appliance Company. It is inserted by means of withdrawal and removed by pulling the filament.
Ⅲ. Statistic method:
All the documents and data were edited and inputted into computers twice by using the software Epi Info/nt/2000. After checking, we were sure that the documents and data were without any mistake, then we used SPSS statistical software package to analyze. The result was analyzed by means of Tietze-Potter life method. X2 and Student’s t test were used to prove their obvious difference.
Result
ⅰ. Basic status of the trial women
The total number of trial women for MCu IUD and Tcu380A is 1,100, with 550 for each. After 48 months’ observation, the random visit rates are both ﹥97%. Use 24524, 24476.5 women’s months respectively. There was no obvious difference in basic status in random comparison for each 550 cases, such as age, parity, pregnancy times, depth of the uterus cavity, height, and weight(P﹥0.05).
ⅱ. IUD’s effect
No failure, piercing and infection for all the 1，100 trial women inserted with MCu IUD and TCu 380A IUD during the course of insertion and no broken reported during use. Clinical data on women with MCu IUD and TCu380A IUD after inserting for 48 months shows that both IUDs have statistics discrepancy. P＜0.05. The continuous remaining rate, pregnant rate with IUD inserted, removal rate due to adverse symptom of MCu IUD are lower than that of TCu 380A IUD, but refer to table 1, there is no statistics discrepancy.
Table 1 The Follow-up Effects in 12, 24, 36, and 48 Months after Being Inserted with Two Kinds of IUD
|
Classification |
MCu IUD |
Tcu380A IUD | ||||||||||||||
|
12months |
24month |
s36months |
48month |
s12months |
24months |
36months |
48months | |||||||||
|
n |
% |
n |
% |
n |
% |
n |
% |
n |
% |
n |
% |
n |
% |
n |
% | |
|
Pregnancy |
2 |
0.37 |
2 |
0.38 |
4 |
0.81 |
6 |
1.26 |
1 |
0.19 |
2 |
0.38 |
3 |
0.61 |
8 |
1.72 |
|
pregnancy with IUD inserted |
2 |
0.37 |
2 |
0.38 |
4 |
0.81 |
6 |
1.26 |
1 |
0.19 |
2 |
0.38 |
3 |
0.61 |
8 |
1.72 |
|
Accident pregnancy |
0 |
0.00 |
0 |
0.00 |
0 |
0.00 |
0 |
0.00 |
0 |
0.00 |
0 |
0.00 |
0 |
0.00 |
0 |
0.00 |
|
Expulsion |
0 |
0.00 |
0 |
0.00 |
1 |
0.20 |
2 |
0.42 |
8 |
1.48* |
9 |
1.73* |
11 |
2.23* |
16 |
3.45* |
|
Complete expulsion |
0 |
0.00 |
0 |
0.00 |
1 |
0.20 |
1 |
0.21 |
1 |
0.19 |
1 |
0.19 |
1 |
0.20 |
1 |
0.22 |
|
Partial expulsion |
0 |
0.00 |
0 |
0.00 |
0 |
0.00 |
1 |
0.21 |
7 |
1.29* |
8 |
1.54* |
10 |
2.03* |
15 |
3.23* |
|
Removal due to illness |
11 |
2.01 |
11 |
2.10 |
17 |
3.43 |
20 |
4.19 |
10 |
1.84 |
14 |
2.69 |
22 |
4.46 |
27 |
5.82 |
|
Pain |
2 |
0.37 |
2 |
0.38 |
2 |
0.40 |
2 |
0.42 |
1 |
0.18 |
1 |
0.19 |
2 |
0.41 |
3 |
0.65 |
|
Bleeding |
7 |
1.27 |
7 |
1.34 |
11 |
2.22 |
14 |
2.93 |
6 |
1.11 |
7 |
1.35 |
14 |
2.84 |
18 |
3.88 |
|
Pain and Bleeding |
2 |
0.37 |
2 |
0.38 |
4 |
0.81 |
4 |
0.84 |
3 |
0.55 |
6 |
1.15 |
6 |
1.22 |
6 |
1.29 |
|
Stop use |
13 |
2.37 |
13 |
2.48 |
22 |
4.44 |
28 |
5.87 |
19 |
3.48 |
25 |
4.81* |
36 |
7.30* |
51 |
10.99* |
|
Non-medical reason |
1 |
0.18 |
6 |
1.14 |
24 |
4.84 |
34 |
7.13 |
1 |
0.18 |
1 |
0.19 |
14 |
2.84 |
25 |
5.39 |
|
Follow-up visit rate |
100.00 |
98.88 |
98.48 |
97.82 |
99.10 |
99.25 |
98.66 |
98.00 | ||||||||
|
Continuous application rate |
97.45 |
95.26 |
89.20 |
84.82 |
95.44 |
94.25 |
88.52 |
81.62 | ||||||||
|
Number of women |
6511 |
13239.5 |
19254 |
24524 |
6414 |
13015.5 |
19001.5 |
24476.5 | ||||||||
ⅲ. Side effects after insertion
During random visits after insertion for 48 months, chief complaint of TCu IUD group was higher than that of MCu IUD group (no chief complaint means that the user say that there is no adverse symptom without hint). Chief complaints are mainly about irregular menstruation and pain of the bythus at different degree. There is apparent difference. P＜0.05. Refer to table 2.
Table 2 Complaints after Inserting the Two Kinds of IUD for 12, 24, 36, and 48 Months
|
Classification |
12months |
24months |
36months |
48months | |||||||||||||
|
MCu IUD |
TCu380A IUD |
MCu IUD |
TCu380A IUD |
MCu IUD |
TCu380A IUD |
MCu IUD |
TCu380A IUD | ||||||||||
|
n % |
n % |
n % |
n % |
n % |
n % |
n % |
n % | ||||||||||
|
Complaint |
64 |
11.94* |
107 |
20.38 |
49 |
9.33 |
54 |
10.38 |
32 |
6.45* |
49 |
9.94 |
18 |
3.77* |
36 |
7.76 | |
|
No complaint |
473 |
88.06 |
424 |
79.62 |
476 |
90.67 |
466 |
89.62 |
464 |
93.55 |
444 |
90.06 |
455 |
96.23 |
431 |
92.24 | |
|
Total |
536 |
100.00 |
525 |
100.00 |
525<, /P> |
100.00 |
520 |
100.00 |
496 |
100.00 |
493 |
100.00 |
477 |
100.00 |
464 |
100.00 | |
iv. Pregnancy status after removing IUDs
In this study, we have a research object, which is investigating the planned pregnancy. Seven MCu IUDs have been taken out, and 5 women pregnant within one year after removing IUDs. The remaining 2 women are not pregnant after half a year. Six TCu IUDs have been taken out for planned pregnancy, and 5 women pregnant. Others are still in the period of contraception. Among the two groups, most women who plan for pregnancy are pregnant within one year after removing IUDs. The results prove that both kinds of IUDs have good reversibilities.
Discussion
i. IUD expulsion rate information
MCu IUDs apply a special functional and new-type medical metallic material: special shaped memory alloys, of which special arches are made; arcuate arms comply with the uterus cavity. They are considered as the support points in the uterus cavity; the fixed and pressed copper grains are suspended on two arcuate parts of the uterus (the biggest horizontal diameter from the bottom of the uterus cavity). They follow the contraction rountine of the uterus and are not easy to deform, move downward and displaced. After comparison and observation, expulsion rates in clinical observation on 1,100cases after inserting for 48months are 0.42% and 3.45% respectively, further proving that MCu IUD’s expulsion rate is very low in the IUD field.
ⅱ. Contraceptive function
MCu IUD’s copper grains are pressed on the two ends of the arms and release copper ions to enhance the contraceptive effect. Its copper surface is less than 200mm2 . However, it is said that the contraceptive effect of copper depends on its position in the uterus and its surface area. Higher position is better than lower one. On the other hand, big surface area of copper will strengthen its contracep,, , tive effect, but it, also causes hi, gh side effects. MCu IUD’s coppers are put on two horns of the uterus, which is the highest position of it and where a zone with high density of copper ions is formed. Therefore, it still has good contraceptive effects. In this research, the pregnancy rate of 1,100 cases with MCu IUD and TCu IUD observed and inserted for 48 months are 1.26% and 1.72% respectively, therefore MCu IUD’s satisfactory contraceptive effect is proved.
ⅲ. Side effects
The main side effects after insertion are bleeding and pain. MCu IUD's surface is smooth; its supports are very thin; its area contacted with endometrium is small; the copper surface area is small. Shape-memory alloy has very good tissue compatibility; Due to subtle elasticity and tension, MCu IUDs’ two arms can expand and contract as the womb does. It reduces the stimulation to the endometrium, and lowers down the side effect rate caused by all the above characteristics. In this study, the uncomfortable chief complaints of MCu IUD and Tcu IUD are 3.77 per 100 women and 7.76 per 100 women respectively. There was an obvious difference between these two groups. But with respect to the accumulative removal rate due to adverse symptoms, which are 4.19 per 100 women and 5.82 per 100 women respectively, there was no obvious difference between them, though that of MCu group is lower than that of TCu group. These two points prove that MCu IUD has low side effects. After 48 months’ observation, women of neither group get illness and has anemia. MCu IUD has achieved its effect of safety.
ⅳ. The features of MCu IUD
Due to its good clinical effect and special V shape, the indication of MCu IUD is very wide. It not only applies to normal uterus, but also to cervical relaxation and saddle shape uterus, etc. It can be inserted 3-7 days after the completeness of menses or just after the operation of induced abortion. As to the breast-feeding period without any contraindications, it can be inserted and the same good results can be obtained. MCu IUD can be inserted by means of withdrawal, which is easy and safe. And it can be taken out by extractors, which is feasible and simple. MCu IUD can reduce the uncomfortable feelings out of psychology and actual item. Women can get pregnant within a short period after removal. MCu IUD has good reversibility. Clinical effects in reports of recent years are very good. In this study, it is believed that MCu IUD has some characteristics such as good contraceptive effect, low expulsion rate, slight side effect and wide indication, etc. Therefore, it is worthy of being recommended to use widely.
Bibliography
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