Comparison of two uterine cavity-shaped IUDs

Contraception 46:221-226,

COMPARISON

1992

OF TWO

UTERINE

CAVITY-SHAPED

Zeng Qing Gu , Chief Physician, Obstetrics

and Gynecology,

Area People’s Hospital, The following

investigators

Department

Nan -Tong

IUDs

of

Mining

Chongqing , China

and medical units were involved in the clinical study of this trial

Dr. Zhou,

M. J. Department

of Family Planning,

Dr. Tong,

H. S. Department

of Obstetrics

Chongqing

and Gynecology,

Medical College, Nan-Tong

:

China

Mining Bureau Medical

Centre , Chongqing , China Dr. Zeng ,C. Y. Chengtu Family Planning Dr. Deng, Y. L. Department Sichuan,

Guiding Clinic,

of Obstetrics

Sichuan

and Gynecology,

, China

Chengtu

No 7 People’s Hospital,

China

Dr. Deng,A.

Department

tal , Sichuan,

of Obstetics and Gynecology,

Zi-Gong

Municipal First People’s Hospi-

China

Dr. Chong , Y. L. Chongqing Dr. Yang ,Z. Y. Yu-Zou Dr. Cheng,Y.

L. Ging-lin

Chongqing , China

Building Worker’s Hospital,

Factory

Hospital,

Factory

Dr. Cheng Z. L. Nan-Tong

China

Hospital,

China

Town Hospital,

Chongqing,

China

AFSTRACT For the purpose of lowering (first generation

the pregnancy

UCD) and maintaining

(second generation

rate (0.3

the other cumulative not significantly

the copper-plated

UCD or UCDcu) was designed. A randomized

with the UCDcu and UCD have been analyzed pregnancy

rate of the uterine cavity-shaped

its advantages,

per 100 women)

use-effectiveness

removals for bleeding and pain,

for the two IUDs, p>O.

IUD

study in ten centres

The UCDcu had a significantly

than the UCD (2. 9 per 100 women),

rates such as expulsion,

different

at twelve months.

stainless steel IUD

uterine cavity-shaped

p
lower

005. Whereas,

and other personal

were

05.

INTRODUCTION Although

the newly developed uterine

cavity - shaped

6: a‘$

IUD ( 1) has been widely

used in China for its low expulsion

rate,

\v,dm z-

Fn “I

w* -

r g wld* 39 I-

it

still belongs to the inert IUD class and produced an unfavorable

pregnancy

UCDcu has a large surface (Fig.

additional

resulting

The

area of copper

I 1. A very low pregnancy

been obtained,

rate.

from

rate has the use of

copper.

Submitted for publication Accepted for publication

September 3, 1991 June 5, 1992

Copyright 0 1992 Butterworth-Heinemann

Fig.

1.

Capper-plated

uterine cavity-shepcd

IUD WCDru) ;

rhe sutface area ef 0oppet,857mm~, 753mm’. 691mm’.

222

Contraception MATERIAL The UCDcu

weight

has three

of the copper

is 150-

The non-copper-bearing at ten centres. envelopes.

niques

recommended

Table

in Table

study.

A total

for follow-up.

in 2009

women

The insertion

Fig. 3. Completed

to be inserted

is determined

procedure

according

tech-

for insertion.

to the depth

of

of the uterine

Size of device

cavity

:width

Length

mm

22:20

mm

7.5-9.0

cm

24:22

mm

-sized

was used, cavity

and UCD have

The urn.

in Fig. 2 and 3.

20:18

method.

691 mm2. is 38-59

copperor St&using

cm

UCDcu

Follow-up

All women

were inserted

5 cm

method

with a past history

devices

to one of the two groups,

6. 6-7.

sertion

tion.

Both

and

of the device

of the size of the device

only the medium

of the uterine

area.

allocated

753mm?,

layer

I.

5. 5-6.5

depth

857mm?,

of the copper

used for IUD insertion.

I. Determinatjon

blind

of copper:

was used by the clinicians

are shown

the size of the device

Depth

But,

method

by the author

uterine

double-

were randomly

Double-blind

as shown

AND METHODS

area

UCD has the same surface

Fig. 2. Inserters

cavity,

surface

180 mg. The thickness

All the subjects

sealed

Usually,

different

device(

as we usually data

from

been analyzed

accepting of pelvic

22: 2Omm,

the size of device

the IUDs infection,

do in practice. a randomized

at twelve

753mmz)

to be inserted

months

There

using

of I 004 and 1005 devices,

UCDcu

menstruation and UCD,

in the study.

were no insertion

use-effectiveness

were in the reproductive abnormal

was inserted

can’t be determined

study

the same design age range

20-40

or menorrhagia respectively,

failures

to the

with this in-

in ten centres protocol

Because

according

with

the

and data collec-

and healthy.

Women

were not included were inserted

between

in the May

223

Contraception

1 ,1986 to March 31,1987. The cut-off

The subjects were all followed-up

date was March 31,1988.

been accumulated

with each device.

The statistical significance

11,625.

at 1,3,6,12,

5 and 11,548

of experience

have

Life-table analysis was made according to Tie&e and Lewit (2).

in gross rate was tested by (X-square.

liver and renal function,

months post-insertion.

woman-months

copper corrosion in uterine cavity,

Copper and zinc serum levels and

and MBL were also determined pre and 1 ,

3,6 ,and 12 months post-insertion. Menstrual

blood loss in ten cases with the UCDcu and five cases with the UCD were determined by the al-

kaline hematin method of Hallberg and Nilsson (3), (At the beginning of this trial, there were also ten volunteers in UCD group, but 5 of them gave up the determination

of MBL by themselves).The

selection procedure: Women in good health without a past history of menorrhagia

sample

were eligible for en-

rolment into the MBL determination. RESULTS The age, parity and profession distribution of the acceptors were similar. bution of the acceptors ranged in the 20-29

most acceptors were parity 1: 77. 8% for UCDcu,79. 77. 8% for UCDcu,

pain in the UCD group. 1

period revealed only or.+ removal for

of events during 12 months of use are shown in Table

1

.

. Events during 12 months of use

Event

UCDcu

UCD

Pregnancy

3

29

Expulsion

12

23

Removals for bleeding and pain

15

14

Jnfection

0

0

Other medical

6

2

Planning

5

4

pregnancy

Other personal

19

10

Released from study

1

0

Related terminations

60

82

Total terminations

61

82

Number of insertions

1004

1005

Number of continuation

943

923

Woman-months

11,625.5

11,548

of use

Cumulative

in the UCDcu group compared with 29 in the non-copper-bearing

UCD

net and gross rates per 100 women at twelve months of use and the significance

levels of the gross cumulative n.

2% for UCD; most were workers or farmers:

Events in the 48 hours post-insertion The summary

There were 3 pregnancies group.

75. 1% for UCD;

80. 4% for UCD. Both UCDcu and UCD groups were comparable as to the re-

sults of use-effectiveness.

Table

The majority age distri-

years group: 76. 1% for UCDcu,

termination

rates between UCDcu and UCD groups are given in Table

Contraception

224 Table

II.

net and gross rates per 100 women

Cumulative

levels of the difference

at 12 months

of use and significance

in gross rates between UCDcu and UCD Net rate

xe

Gross rate

P

UCDcu UCD

UCDcu UCD

Pregnancy

0. 3

2. 8

0. 3

2.9

21.1

Expulsion

1. 2

2. 3

1.2

2. 4

3. 5

>o.

Bleeding and pain

1. 5

1. 4

1. 5

1. 4

0. 0

>O. 25

Other medical

0. 6

0. 2

0. 6

0. 2

0

0

0

0


005 05

(0.03)

Infection

2.0

>o.

05

0. 5

0. 4

0. 5

0. 4

0. 1

=o.

75

Other Personal

1.9

1. 0

1.9

1.0

2.7

>o.

1

Released from study

0. I

0

0. 1

0

Planning

pregancy

6. 0

Related terminations Continuation

The results of this investigation cu group

pain,

(0. 3) was significantly

91.9

indicated that the pregnancy

lower than the pregnancy

, p
(2. 9)

8. 1

94. 0

rate

and other medical were not significantly

rate at 12 months of use in the UCD

rate in the non-copper-bearing

UCD group

rates related to IUD use, such as expulsion,

bleeding and

different

between the two groups,

gia and spotting are the main post-insertion

side effects for both types of BJDs,

lowing long-term

at the first month post-insertion

and 38. 6% sertion,

use. The total incidence

(388/1005)

for UCDcu and UCD

it had decreased

to 12%

results are shown in Table

Table

N.

(120/1004)

,respectively,

Changes of MBL pre-

was 45. 6%

(457/

1004)

01, but at twelve months post-in-

and 8. 7% (87/1005),

respectively,

p
05.

The

and post-insertion Past -insertion

(ml)

UCD

05. Menorrha-

lV .

Pre-insertion

UCDCU

p
p>O.

but they decreased fol-

1 month

3 months

6 months

M+SD

M&SD

M&SD

6

60.2f31.8

58. 9f8.

3

48. 5&6.

2

51.1*20.3

48. 3f2.

0

45. o*t?.

3

7

70. 4+24.

37. 7f2.

0

54.2k

Copper and zinc serum levels,

The results are shown in Table

and liver and renal function

UCDcu were determined V.

MfSD

18. 8

31. l&8.

subjects with the medium-sized

12 months

tests performed

in ten of the same

pre- and 1 ,3,6, and 12 months post-insertion,

225

Contraception Table

V . Cu++ and ZnfC

serum levels and liver and renal funcition

pre-

and post-insertion

Post-insertion

Pre-insertion 1 month

3 months

6 months

12 months

Cu(uddl)

104.4

105.8

99. a

118.7

104. 6

Zn (w/d1 1

80. 1

85. 1

89. a

119.9

106. 1

3. 0

3. 6

3. 7

3. 5

3. 6

a. 0

8. 0

8. 6

9. 0

8. 9

normal

Thymol

turbidity

Zinc sulfate

test (u>

turbidity

test (u>

GPT(u) BUN(mg) Cr(mg)

Although and Zn++

the surface

in serum

normal

normal

normal

normal

13.5

12. 2

9. 1

9. 7

11. I

1. 2

1.2

1. 1

1. 2

1. 0

area of copper in the UCDcu is large,

(except

it neither increased

the level of Cu+ +

Zn++ value at 6 months slightly elevated ) nor affected

liver and renal

function. Copper corrosion ious reasons days.

of the medium-sized

by balance

The average

method.

weight of copper corrosion

cases with the UCDcu were obtained pregnancy, IUD.

and 1 for personal

reason.

polymorphonucleat

leucocytes

was 107. 4 ug/per

day.

Endometrial

due to abnormal

All the biopsies were performed causing superficial

and mononuclear

below the IUD site and microthrombi

in the devices removed for var-

time of these devices in the uterus

1 11 were terminated

The UCDcu eroded the endometrium

genic changes

UCDcu was also determined

The mean retention

bleeding,

and plasma cells. Extensive

15

3 for planning

at the time of removal

chronic endometritis,

and fibrin coagulation

was 221. 6

biopsy from

of the

with infiltration

hemorrhage

of

in the stroma

in blood vessels were found.

No carcino-

were found. DISCUSSION

For the purpose of improving ed UCD (UCDcu) been analyzed

was designed.

on the pregnancy A randomized

at 12 months in ten centres.

for the UCDcu (0. 3 per 100 women) 100 women) Whereas, pain, 05.

other medical, Although

planning

the surface

indicate

difference

between

pregnancy

and other personal

users and should cause no toxic manifestation,

relatively pregnancy achieved

stable

Usually, (5).

after two years of insertion,

low level,

both high continuation

face area of copper.

Many

without

rate

p
005.

for bleeding and different,

p> 0.

of copper ions released

liver or renal function.

by adults

(4).

absorbed.

Nutri-

so it is safe for the The weight of the

of copper can release copper ions for more

the use-effectiveness

of the IUD has become

that the use of copper on the UCDreduces

increasing

and very low pregnancy

Chinese investigators

removals

the amount

even if it is completely

The results of this study revealed

rate to a very

the two types of IUDs,

the serum copper levels nor damaged

that 2000 to 5000 ug daily of copper is required

pregnancy

rate for the UCD (2. 9 per

were not significantly

area of copper in the UCDcu is large,

copper layer on the UCDcu is 150 to 180 mg. This quantity than three years.

that the gross cumulative

rates related to IUD use. such as expulsion,

from the UCDcu neither increased tionists

The data indicated

UCD, the copper-plat-

study with the UCDcu and UCD has

was much lower than the pregnancy

+ there was a very significant

the other termination

rate of the first generation

use-effectiveness

the other

termination

rates.

the

The UCDcu

rates due to its special shape and large sur-

believe that many sizes of IUDs are necessary,

the

226

Contraception

author agrees with their view. So,

we designed three different sizes of devices

ties. The two devices under investigation

were less than that defined as menorrhagia, long-term

for various uterine cavi-

increased MBL at all intervals studied (Table MBL exceeding

80 ml (6).

Iv ) , but all

MBL decreases following

use. ACKNOWLEDGEMENTS

The author is grateful to Dr. Xiao Bi Lian, Family Planning,

Beijing, China,

the director of the National Research Institute for

for her concern and revision of the manuscript. REFERENCES

1. Zeng Qing Gu et al. A comparison steel single ring.Prac 2.

Tietze C,

Lewit

J O&et

Gynec 1986;

stainless steel IUD and stainless

2: 166

S. Recommended procedures for the statistical evaluation of intrauterine

tion. Stud Fam Plann 1973; 3. Hallberg

between uterine cavity-shaped

L, Nilsson

contracep

4:35.

L. Determination

of menstrual

blood loss. Stand J Clin Lab Invest 1964;

16:244. 4. Tatum 1973;

H. J. et al. Metallic copper as an intrauterine

5. The Second Clinical Group of National study of three typs

IUD Research.

of IUD (2 years follow-up).Reprod

6. Xiao Bi Lian et al.Measurement 160.

contraceptive

agent.

Am J Obstet Gynecol

117,602. A randomized Contracep 1987;

of menstrual blood loss. Chinese J

multicentre 7 :39-

comparative

47.

Obst Gynecol 1980;

15 : 59 -