Journal of Family Planning & Gynecology, 2012, Vol.4, No. 1

Comparison of clinical application about MYCu IUD and TCu220C IUD

XU Hong, WANG Hui-ying

Department of Obstetrics and Gynecology, Jiading Center Hospital in Shanghai, Shanghai 201800, P.R. China

[Abstract] Objective To observe the clinical effect of AiMu-brand MYCu intrauterine contraceptive device (IUD) and TCu220C IUD.  Methods About 300 in reproductive age requested IUD being inserted in Jiading Central Hospital of Shanghai City.  Respectively 150 cases were inserted randomly MYCu IUD and TCu220C IUD and regularly were followed-up in the first, third, sixth and twelfth month after insertion.  Results The differences were no significance respectively (p>0.05) that the accumulative pregnancy rates were 0.67/hundred women years and 0.67/hundred woman years respectively after inserted 12 months; accumulative expulsion rates were 0.67/ hundred woman years and 2.00/ hundred woman years; accumulative removal rates due to side effects were 2.01/hundred woman years and 4.14/hundred woman years respectively.  The continuation rate was 96.00/hundred woman years and 92.30/hundred woman years respectively.  The complaints rate mainly including bleeding and pain of MYCu IUD Group were lower than those of TCu220C IUD group during the 4 follow-up visits that the difference was obvious significant (p<0.05).  Conclusion MYCu IUD with high contraceptive efficacy, low expulsion rate and less side effect is so comparatively ideal IUD that it is worth further being promoted. 

[Key Words] intrauterine contraceptive device; MYCu IUD; TCu220C IUD;  clinical effect.

 [Chinese Library Classification] R169.4    [Document code] A  

[Article number] 1674-4020(2012)01-042-04

doi:10.3969/j.issn.1674-4020.2012.01.012  

Intrauterine contraceptive device (abbreviated as IUD) is a safe, effective, easy, convenient, and reversible contraceptive device.  It is also the main contraceptive device for women of child-bearing age in China.   At present, there are many kinds of IUDs in China, among which copper IUD is the most popular.   For IUDs are different in material, structure and shape, and woman of child-bearing age has individual difference, problems such as pregnant with IUD in situation, expulsion, removal for side effects or intolerant side effects are to be solved.   The newly researched MYCu IUD in China was launched into market at the end of 2009.  To observe its contraceptive effect, expulsion rate, occurrence rate of side effects, this hospital compared MYCu IUD with TCu220C IUD which has low cumulative adverse termination rate in 5 years for 150 cases respectively, and the result is as follows. 

1.      Data and method

1.1  Research subjects

From May 2010 to August 2011, 300 healthy women 20 ~40 years old, with regular menstruation, require to use IUD for contraception, without contraindication, with uterine cavity of 7 ~9cm, hemoglobin (Hb) ≥100g/L from the out-patient department of our hospital were inserted with MYCu IUD and TCu220C IUD each for 150 cases.  The difference between subjects of two groups in age, gravidity/parity time, result of last pregnancy, depth of uterine cavity had no statistical significance(p>0.05).  Thus was comparable, details see table 1. 

Table 1 Comparison of general situation of two groups (( ±s)

 

n

 age(years)

gravidity (time) 

parity (time)

 result of last pregnancy(%)  

vaginal delivery  cesarean section  induced abortion

 insert at mens.  intervals(%)

insert during suckling period when uterus hasn’t returned to normal(%) 

insert immediately after induced abortion(%)

depth of

uterine

cavity

(cm)

MYCu

150

28.29±4.29

1.91±0.93

 1.15±0.37

48.00

20.67

31.33

84.00

1.33

14.67

 7.19±0.44

TCu220C

150

28.02±3.89

1.75±0.86

 1.12±0.36 

51.33

17.33

31.33

84.67

1.33

14.00

  7.10±0.35

X2or t value

 _

0.5710

1.5250

0.9434

0.1122

0.3686

0.0147

0.0203

1.9651

P value

 _

 >0.05

>0.05

>0.05

>0.05

>0.05

>0.05

>0.05

>0.05

>0.05

>0.05

1.2 Observed IUD types

MYCu IUD is produced by Liaoning AiMu Medical Science & Technology Co., Ltd.  With copper surface area of 225mm2, its support has temperature memory effect, and there is 25 mg indomethacinn contained in silicon gel tubes on its side arms.  TCu 220C IUD is produced by Tianjin Medical Instrument Factory.  It has plastic T shape support.  Its cross arm is constituted by two copper sleeves while longitudinal arm is constituted by 5 copper sleeves.  The total copper surface area is 220 mm2

1.3 Methods

Women of child-bearing age and match the conditions for IUD insertion was chosen to insert IUD 3~7 days after menstruation cleans or immediately after induced abortion by specially trained doctors.  Insertion method: strictly followed operation procedures and instruction for use of 2 kinds of IUDs; followed up 1, 3, 6 and 12 months after insertion; knew chief complaints after insertion; confirmed IUD’s position by X ray, ultrasonic wave or tail observing method; and filled in records uniformly. 

1.4 Statistical processing

SPSS 13.0 statistical analysis system and table life method were adopted to calculate termination and continuation rate for each item of two IUD groups respectively; x2 inspection or t valued were used to evaluate their effect, and p<0.05 was used to indicate the difference had statistical significance. 

2.      Results

2.1 Clinical result

Two groups of subjects inserted with MYCu IUD and TCu220C IUD respectively were followed-up 1, 3, 6 and 12 months after insertion.  Observing for 12 months, in total 17 cases terminated. The cumulative termination rate of MYCu IUD group was 4.00/per 100 woman year and that of TCu220C IUD group was 7.30/per 100 woman year.  The difference in comparison between two groups on expulsion and removal due to adverse events had no statistical significance (p>0.05).  Details of effect analysis see table 2. 

Tabel 2  Application effect comparison between two groups after insertion for 12 months

Reason for termination

          MYCu group

          TCu220C group 

 x2

p value

 

n

crude rate/per 100 woman year

n

 crude rate/per 100 woman year

 

 

Pregnant with IUD in situ.

1

0.68

1

0.69

_

_

expulsion 

1

0.67

3

2.03

1.0135

>0.05

completely expulsion

0

0.00

0

0.00

_

_

partial expulsion

0

0.00

0

0.00

_

_

remove for downward displacement

1

0.67

3

2.03

_

_

remove for medical reasons

3

2.04

6

4.07

1.0309

>0.05

remove for pain

2

1.36

3

2.05

_

_

remove for bleeding

0

0.00

2

1.38

_

_

remove for pain and bleeding

1

0.69

1

0.69

_

_

termination related to IUD application

5

3.36

10

6.67

1.5877

>0.05

lost to follow-up

1

0.67

0

0.00

 

 

termination for other personal reasons

0

0

1

0.71

 

 

total termination rate

6

4.00

11

7.33

1.3921

>0.05

continuous application rate

96.00

92.67

 

 

 

 

applied woman month

1830

1779

 

 

 

 

2.3 Chief complaint and side effect

In follow-up visits 1, 3, 6 and 12 months after insertion, chief complaint in MYCu IUD group was less than that in TCu220C group, the difference had statistical significance (p<0.05﹚.  Many inter-group comparison had statistical significance (p<0.05﹚.  Main side effects from chief complainer were abnormal menstruation, waist and abdomen pain, and increasing leucorrhea volume.  In 9 cases, IUD was removed out for intolerant side effects, 3 be MYCu IUD and 6 be TCu220C IUD.  Women returned to normal after IUD removed out.   Details of chief complaint and side effects see table 3. 

2.4 Follow-up situation

300 subjects were successfully inserted with IUD.  5 subjects had MYCu IUD removed out.  There was clear metal friction sense during detection by probe and the removal processes were trouble-free.  11 subjects had TCu220C IUD removed out.  The removal processes were also trouble-free and there was no infection and damage during operation.  No anemia and severe adverse event occurred during 4 follow-up visits. 

Table 3 Comparison of chief complaint and side effects between two groups after observing for 12 months  

 

 chief complaint 

 abnormal menstruation

  irregular bleeding

 waist and abdomen pain

 increasing leucorrhea  

n

total amount after 1 month

92(30.67)

55(18.33)

12(4.00)

54(18.00)

20(6.67)

300

MYCu

35(23.33)

20(13.33)

5(3.33)

21(14.00)

7(4.67)

150

TCu220C

57(38.00)

35(23.33)

7(4.67)

33(22.00)

13(8.67)

150

x2 value

7.5878

5.0093

0.3472

3.2520

1.9286

_

p value

<0.01

<0.05

>0.05

>0.05

>0.05

_

total amount after 3 months

56(18.98)

37(12.54)

5(1.69)

29(9.83)

12(4.07)

295

MYCu

17(11.41)

11(7.38)

2(1.34)

9(6.04)

4(2.68)

149

TCu220C

39(26.71)

26(17.81)

3(2.05)

20(13.70)

8(5.48)

146

x2 value

10.8346

7.0624

0.2103

4.7064

1.4177

_

p value

<0.01

<0.01

>0.05

<0.05

>0.05

_

total amount after 6 months

31(10.84)

22(7.69)

4(1.40)

13(4.55)

10(3.50)

286

MYCu

8(5.44)

5(3.40)

1(0.68)

4(2.72)

2(1.36)

147

TCu220C

23(16.55)

17(12.23)

3(2.16)

9(6.47)

8(5.76)

139

x2 value

11.1477

7.9352

1.1465

2.3585

4.1341

_

p value

<0.01

<0.01

>0.05

>0.05

<0.05

_

total amount after 12 months

22(7.77)

16(5.65)

1(0.35)

9(3.18)

10(3.53)

283

MYCu

4(2.78)

4(2.78)

0(0)

2(1.39)

2(1.39)

144

TCu220C

18(12.95)

12(8.63)

1(0.72)

7(5.04)

8(5.76)

139

x2 value

10.2071

4.5460

1.0396

3.0554

3.9561

_

p value

<0.05

<0.05

>0.05

>0.05

<0.05

_

3 Discussions

MYCu IUD has a copper surface area of 225 mm2.  For copper grains are fixed and pressed on the end of its arms and copper sleeves are installed on its side arms, active contraceptive substance copper ions fulfill the whole uterine cavity, thus further strengthens contraceptive effect[2].   TCu220C IUD recommended by WHO has been applied in China for many years.  In this study, 2 different IUDs were randomly inserted for 150 cases respectively.   Observing for full 12 months, the rates of pregnancy with IUD in situation were both 0.67/per 100 woman year, the difference had no statistical significance (p>0.05), and 2 kinds of IUDs were proved to be with good antifertility effect. 

MYCu IUD is a new-type functional IUD developed in China.  Its support is made of TiNi shape memory alloy intelligent material, can keep the designed shape within human body temperature and has ultra-elasticity, not easy to deform, has fatigue resistance and good tissue compatibility.  Besides, it is designed according to uterus shape and dynamic mechanism; its two arms have given field angle and assume completely open V shape, thus better suit the shape of uterine cavity.  Moreover, with subtle elasticity, its support can contract and expand as the womb does, make it is not easy to move downward and expulse [3, 4].  In this study, the expulsion rates of subjects in MYCu IUD group and TCu220C IUD group were 0.67/per 100 woman year and 2.00/per 100 woman year, showing a trend that the expulsion rate of MYCu IUD group was lower than that of TCu220C IUD group, but since p>0.05, the difference had no statistical significance.  Maybe the sample size is small and large sample observation is needed. 

Through observation, one can see that side effects such as abnormal menstruation, pain, and increased leucorrhea volume after MYCu IUD insertion were obviously lower than that after TCu220C IUD insertion.  In many inter-group comparison, p<0.05, the difference had statistical significance.  This maybe for 25 mg indomethacin contained in MYCu IUD’s side arms releases indomethacin during early insertion to decrease the synthesis of prostaglandin, thus the side effects of bleeding and pain were decreased [5]

 For MYCu IUD is without tail, the possibility of retrograde infection is avoided, discomfort at sexual life brought by tail is extinguished, and the occurrence rate of chief complaint is decreased.  This is another excellent performance of MYCu IUD. 

The author identifies what reported by Liu Weinan and so on people: correct insertion is critical.  During AiMu IUD insertion, care not oversize, or else will cause pain.  For example, for uterine cavity depth of 7.5cm, large size will be chosen in general IUD application.  But for MYCu IUD, middle size should be chosen (It is said in the instruction for use that for uterine cavity depth of 7.5~8.5 cm, middle size should be chosen).  At the time of insertion, care to slowly withdraw the outside tube to let IUD slowly slip out; too fast withdraw will stimulate uterus and cause pain; keep IUD be parallel with the axis of uterine cavity at insertion to avoid oblique insertion; IUD should be inserted to a position nearing uterus bottom; be care of downward movement and displacement. 

All in all, as a new-type IUD, MYCu IUD has reasonable design, definite contraceptive effect, low expulsion rate, low occurrence rate of side effects, and high continuous application rate.  Women are happy to accept it.  It is a new-type IUD deserving promotion. 

[Reference ]

[1] Department of science and technology, National Population and Family Planning Commission.  “Research Report on IUD’s Contraceptive Effect in 120,000 Cases Inserted with It” [J].  Chinese Journal of Family Planning, 2007, 15(3):132-136. 

[2]Wang Yu, Zhang Sulan, Li Shuzhi and so on people.  “Clinical Study on 1000 Cases with AiMu Brand Functional Intrauterine Devices of the Second Generation Inserted [J]”. Journal of Practical Obstetrics and Gynecology, 2010, 26(9):705-707.  

[3] Fu Xiaomin, Nie Lei, and Song Xike.   “Observation on the Clinical Contraceptive Effect of 3 Kinds of IUD in 1-year Follow-up Visits [J]”.  Chinese Journal of Family Planning, 2007, 15(2):100-103.  

[4]Gong Yanhong, Lv Lin, and Zhang Wei.  “Clinical Observation on 270 Cases with MCu Functional Intrauterine Devices Inserted [J]”. Journal of Family Planning & Gynecology, 2010, 2(6):63-66.  

[5]Li Shuzhi, Zuo Wenli, Wu Shuying and so on people.  “Random Contrast Study on MYCu Intrauterine Device Containing 25mg Indomethacin [J]”. Chinese Journal of General Practitioners, 2010, 9(11):760-764. 

[6]Liu Weinan, Li Jianwei, and Liu Zhong.  “Clinical Application of MCuII IUD and MCu IUD [J]”. Journal of Family Planning & Gynecology, 2011, 3(5):67-69. 

                                                             (Received date: 2011-12-13)  

2012年06月12日

Comparison of clinical application about MYCu IUD and TCu220C IUD

Journal of Family Planning & Gynecology, 2012, Vol.4, No. 1 Comparison of clinical applicatio

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