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The acceptability, efficacy and safety of quinacrine non-surgical sterilization (QS), tubectomy and vasectomy in 5 provinces in the Red RiverDelta, Vietnam: a follow-up of 15,190 cases

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The article aims to compare the safety, efficacy and acceptability of quinacrine sterilization (QS), tubectomy and vasectomy in Vietnam.
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Content Preview
International Journal of Gynecology and Obstetrics 83 Suppl. 2 (2003) S77–S85
www.elsevier.com/locate/ijgo
The acceptability, efficacy and safety of quinacrine non-surgical
sterilization (QS), tubectomy and vasectomy in 5 provinces in the
Red River Delta, Vietnam: a follow-up of 15,190 cases
D.T. Hieua, °, T.T. Luongb, P.T. Anhb, D.H. Ngocb, L.Q. Duongb
aDirector (retired), Department of Maternal and Child Health/Family Planning, Ministry of Health, Hanoi, Vietnam
bDepartment of Maternal and Child Health/Family Planning, Ministry of Health, Hanoi, Vietnam
Abstract
Objectives: To compare the safety, efficacy and acceptability of quinacrine sterilization (QS), tubectomy and vasectomy
in Vietnam. Methods: This study was initiated in January 1998 and completed in February 2000. A sample of 9 districts in
5 provinces, where the prevalence of QS was known to be high, was selected. Every person sterilized in these 9 districts
between January 1, 1988 and March 31, 1998 was identified and systematically interviewed by family planning clinicians
who had received special training for this project. Results: A total of 15,982 sterilization users were identified and 15,190
were interviewed and examined, including a gynecologic exam, if needed: a follow-up rate of 95%. Of those interviewed,
9,753 used tubectomy, 3,734 used QS and 1,703 used vasectomy. All three methods were found to be safe, although morbidity
associated with tubectomy was more serious than with QS or vasectomy. No deaths were reported. After more than 5 years
of follow-up, tubectomy had the lowest failure rate: 1.0%, followed by 4.1% with vasectomy. A pregnancy rate of 13.2% was
reported with quinacrine, although only a small fraction of these failures were confirmed. A strong preference for QS was
found. Conclusion: QS has an important role to play in sterilization services in Vietnam.
© 2003 International Federation of Gynecology and Obstetrics. Published by Elsevier Science Ltd. All rights reserved.
Keywords: surgical sterilization, quinacrine sterilization, female sterilization, vasectomy
1. Introduction
fallen to 2.48 nationally and to 1.91 in the province of
Thai Binh (Table 3).
The use of contraception increased substantially in
Until the late 1980s, family planning in Vietnam
Vietnam during the decade of the 1990s, especially in
relied chiefly on IUD use with abortion or menstrual
the provinces of the Red River Delta (Table 1). This is
regulation (MR) as a back up. Until 1990, tubectomy
a reflection of both the desires of couples for smaller
was rarely performed and then only in association
with cesarean section or surgical treatment in the
families and the effort made by the government to make
abdomen or pelvis. Interval sterilization was rarely seen
family planning services available. The crude birth
in Vietnam before 1990. This method accounted for
rate (CBR) and the proportion of couples with more
less than 1% of the method mix. In 1989, quinacrine
than 3 children fell precipitously during this decade
sterilization (QS) was introduced to the family planning
(Table 2). By 1998, the total fertility rate (TFR) had
program by the Ministry of Health. It was widely
accepted until 1993 when the program was halted
* Corresponding author. Tel./Fax: 84-4-943-3207.
E-mail address: ngaquan2000@yahoo.com
for re-evaluation following a letter from the World
Correspondence address: 41 Tran Quoc Toan, Hanoi, Vietnam
Health Organization claiming that quinacrine probably
0020-7292/03/$ – see front matter © 2003 International Federation of Gynecology and Obstetrics. Published by Elsevier Science Ltd.
All rights reserved.
PII: S0020-7292(03) 00000-0

S78
D.T. Hieu et al. / International Journal of Gynecology and Obstetrics 83 Suppl. 2 (2003) S77–S85
Table 1
Contraceptive prevalence rate (CPR) in Vietnam and in the 5 study provinces during the 1990s a,b
Area
1992
1996
1998
All
modern
All
modern
All
modern
methods CPR
methods
methods CPR
methods
methods CPR
methods
Vietnam
53.8
41.3
68.3
52.9
71.9
57.9
Hai Duong
66.3
62.7
79.1
71.0
80.6
71.2
Hung Yen
78.9
72.4
Thai Binh
73.3
67.1
80.9
71.1
79.1
69.6
Nam Dinh
63.6
57.5
74.1
65.1
72.8
67.6
Ha Nam
77.4
72.8
a Data from the Vietnam Government Statistical Office.
b Note: In late 1986, Hai Hung Province was divided into Hai Duong and Hung Yen Provinces. At the
same time, Nam Ha Province was divided into Nam Dinh and Ha Nam Provinces. The data in the
table for 1992 and 1996 are for the original larger provinces before subdivision.
Table 2
Population and crude birth rate (CBR) of Vietnam and the 5 study provinces during the 1990s a
Area
Population (per 1000)
CBR (per 1000)
Over 3 children
1992
1996
1999
1992
1996
1999
1992
1996
Vietnam
68,361
74,310
76,325
30.0
22.8
19.9
37.1
32.7
Hai Duong
2,614
2,780
1,650
24.5
18.2
18.8
21.3
18.5
Hung Yen
1,069
19.8
Thai Binh
1,741
1,831
1,786
21.7
19.2
15.5
18.1
11.4
Nam Dinh
2,538
2,721
1,888
26.6
20.9
18.5
33.8
28.9
Ha Nam
792
18.2
a Vietnam Government Statistical Office surveys 1992, 1996, and 1999.
causes cancer [1]. The program has not resumed. In
Table 3
1990, the no-scalpel vasectomy was actively introduced
Population, crude birth rate (CBR) and total fertility rate (TFR) in
to Vietnam by the Ministry of Health. In 1992 and
Vietnam and in the 5 study provinces in 1998 a
1993, the Ministry undertook a major effort to promote
Area
Population
CBR
TFR
the use of tubectomy and vasectomy. The number of
(1998 census)
(1998 census)
sterilization procedures in Vietnam grew rapidly from
1990 to 1994. A part of this growth was due to QS,
Vietnam
76,324,753
19.89
2.48
especially in the provinces of the Red River Delta.
Hai Duong
5,037,155
18.77
2.28
However, the bulk of the growth was due to surgical
Hung Yen
1,047,040
19.77
2.42
sterilization. The rapid growth in surgical sterilization
Thai Binh
1,173,820
15.49
1.91
can be attributed to the national government’s incentive
Nam Dinh
716,427
18.52
2.32
policies for three groups: providers, promoters and
Ha Nam
965,240
18.15
2.30
especially for users. In 1995, the number of surgical
a Source: Vietnam 1998 population census, 1999.
procedures declined rapidly (Table 4), including in the
Red River Delta, and this decline continues.
One difficulty in evaluating QS has been the assess-
QS was offered in Vietnam, pregnancy tests were
ment of failure of this procedure. During the period
unavailable. The price of a pregnancy test was US$6

D.T. Hieu et al. / International Journal of Gynecology and Obstetrics 83 Suppl. 2 (2003) S77–S85
S79
Table 4
Sterilization distribution by year in Vietnam and in the 5 study provinces during the 1990s. a
Area
Number of users
1991
1992
1993
1994
1995
1996
1997
1998
Vietnam
21,092
48,703
120,503
143,104
129,645
121,043
99,391
94,356
Hai Duong
4,085
8,076
7,000
4,408
3,824
1,600
1,298
Hung Yen
1,025
861
Thai Binh
1,383
3,354
3,786
4,488
3,500
1,961
1,223
837
Nam Dinh
3,405
4,503
5,692
4,217
2,888
2,669
1,740
1,317
Ha Nam
577
466
a Data from the Vietnam Government Statistical Office.
which the government could not afford. In comparison,
the true pregnancy rate, which will never be known.
the cost of a QS procedure was under US$1. Thus,
Further study is needed to refine previous estimates.
if a woman was late for her menstrual period and
Sterilization is an important part of the contraceptive
believed she was pregnant, she simply reported to
mix and is critical in reducing the need for abortion.
the commune health clinic and requested a menstrual
The purpose of this study is to compare sterilization
regulation (MR) procedure. There was never any
methods used in Vietnam and to determine why
confirmation of pregnancy. Pregnancy was assumed.
the practice declined so sharply in the 1990s. Such
It was decided that the best approach to evaluate QS,
knowledge will enable us to plan a superior strategy
given that no pregnancy tests were available, would be
to increase the use of sterilization.
to determine the worst-case scenario. The worst case
would be that every woman reporting to the clinic
with a late period following QS was in fact pregnant.
2. Methods
In other words, any woman who missed her period
and obtained an MR was reported as a pregnancy
This retrospective study included both an interview and
failure of QS. This was the only approach available to
a clinical examination. The study sample was chosen in
us at the time and represented at best a crude estimate
the following manner:
of the failure rate. Unfortunately, amenorrhea is a
Five provinces where QS, tubectomy and vasectomy
frequent side effect of QS compelling us to estimate a
were known to have been performed in significant
higher pregnancy rate. In a carefully conducted study of
numbers were selected. In each province, 2 districts
menstrual pattern changes following QS in Indonesia,
were chosen except in Thai Binh where only one
Agoestina reported that among women who had regular
district was selected. Each had to meet the following
cycles in the beginning, 26% had amenorrhea after
criteria: All commune health centers must be accessible
the second insertion and 21% after the third [2]. She
by car. The district leadership must express a readiness
does not report on amenorrhea after the first insertion.
to participate and to agree to the need for such a study.
In Chile, Guzman-Serani reported that 35.7% of his
This phase was initiated during the first quarter of
patients experienced amenorrhea after at least one of
1998.
the three insertions [3]. In our paper on 31,781 cases
The name of the districts involved in this study
of QS, we found amenorrhea in only 0.3% of the
were: Bink Luc and Ly Nhan in Ha Nam Province;
women following insertion of quinacrine [4]. Nearly
Xuan Truong and Giao Thuy in Nam Dinh Province;
all of these women, instead of reporting amenorrhea,
Dong Hung in Thai Binh Province; Yen Mo and
said that they were pregnant and asked for and
Nho Quan in Ninh Binh Province; and Chau Giang and
received an MR. Thus, the QS failure rates cited
Tien Lu in Hung Yen Province. Thus, there was a total
in previous publications [4,5] undoubtedly overstate
of 9 districts involved.

S80
D.T. Hieu et al. / International Journal of Gynecology and Obstetrics 83 Suppl. 2 (2003) S77–S85
Investigators were chosen from among health work-
the QS program was halted and the second year of
ers at provincial Maternal and Child Health/Family Plan- the implementation of incentive policies for surgical
ning (MCH/FP) centers of the study provinces (2 physi-
sterilization. The number then decreased rapidly from
cians from each) and from district health centers
4,274 in 1993 to 861 in 1997. The experience in
(1 physician from each). A district team consisted of
the study districts thus paralleled that of the country
2 physicians (1 provincial and 1 district) and 1 or 2
as a whole as shown in Table 4. Nearly all (99.3%)
midwives/nurses. The team leader was the doctor from
of the 13,487 women were farmers. Their mean age
the provincial MCH/FP center. A 5-day training course
at the time of sterilization was 34.7 years and they
was organized for the 10 doctors from the provincial
had completed a mean of 6.6 years of school. When
MCH/FP centers. They, in turn, organized courses for
asked if they had experienced any pressure to undergo
their district colleagues. All training was conducted in
sterilization, either QS or tubectomy, 13,405 (99.4%)
the second quarter of 1998.
said no while 82 (0.6%) said yes. The latter had
A list of users sterilized between January 1, 1988
pressure from their husbands because their husbands
and March 31, 1998, was completed by the local
did not want another child. 91.6% of the women had
investigators in cooperation with health authorities.
the approval of their husband to obtain the sterilization
Then each user was invited to the commune health
procedure while 8.4% did not.
center (CHC) to be interviewed individually and have a
All women who had opted for tubectomy had
clinical pelvic examination if needed. Interviewing was
received a cash incentive of 150,000 VND (approxi-
initiated in July 1998 and completed in March 1999.
mately US$25) from the authorities according to the
In cases of illness or discomfort, the team leader
regulations of the National Committee for Population
provided the patient with appropriate management
and Family Planning. Among the QS users, 18.2% had
and treatment. She was monitored by the district
investigator. Each woman who participated in the study
received a small gift from local authorities. The
was offered a small gift by the study team. Data
incentives policies applied only to surgical methods of
collection was completed in March, 1999.
family planning and did not include QS.
During the three-year period, 1990 to 1992, most
female sterilization procedures were QS (see Table 6).
3. Results
The national government never promoted QS and never
funded any incentives for QS. Use of the method was
Table 5 presents the number of sterilization users
halted by the government in December 1993 when
and the number of interviewees by method. The total
a letter arrived from the World Health Organization
number of users was 15,982 and the total number
(WHO) claiming that quinacrine probably causes can-
of interviewees was 15,190. The percent of follow-
cer. However, the number of QS procedures performed
up ranged from 92.8% to 96.2%, exceedingly high
given the numbers of years that had passed since
had plummeted from 1,910 in 1992 to 244 in 1993 even
sterilization.
before WHO intervention. Because the demand was so
Table 6 shows that the number of both female and
strong, a handful of QS cases were carried out after the
male sterilizations procedures peaked in 1993, the year
program was officially halted. In 1992 the government
began offering incentives for tubectomy and vasectomy
Table 5
and their number increased rapidly, peaking the next
Number of users and interviewees by method who were sterilized
year, but then they declined rapidly.
between 1989 and 1998 in the 9 sample districts, Vietnam
Table 7 presents the outcomes of all pregnancies
of all women interviewed prior to their sterilization
Method
No. users
No. interviewees
Interview rate
procedures. Child loss was remarkably low. While the
Tubectomy
10,139
9,753
96.2
mean number of childbirths was 3.4, the mean number
QS
4,008
3,734
93.2
of living children was 3.3. The women had had an
Vasectomy
1,835
1,703
92.8
average of just over 1 induced abortion or menstrual
Total
15,982
15,190
95.0
regulation.
Table 8 is most telling. Women who had a single

D.T. Hieu et al. / International Journal of Gynecology and Obstetrics 83 Suppl. 2 (2003) S77–S85
S81
Table 6
Number of sterilization users followed-up in sample districts by method and year, Vietnam
Year
Tubectomy
QS
Vasectomy
Total
N
%
N
%
N
%
N
%
Before 1989
323
93.3
23
6.7


346
100.0
1990
112
21.9
399
78.1


511
100.0
1991
118
9.3
1,141
90.0
8 a
0.7
1,267
100.0
1992
235
10.3
1,910
83.8
134
5.9
2,279
100.0
1993
3,118
73.0
244
5.7
912
21.3
4,274
100.0
1994
2,229
89.3
10
0.4
256
10.3
2,495
100.0
1995
1,467
88.5
5
0.3
185
11.2
1,657
100.0
1996
1,156
89.1
1
0.1
140
10.8
1,297
100.0
1997
811
94.2
1
0.1
49
5.7
861
100.0
1998 Jan−Mar
184
90.6
0
0.0
19
9.4
203
100.0
Total
9,753
64.2
3,734
24.6
1,703
11.2
15,190
100.0
a Before 1992.
Table 7
Table 9
Fertility status of female sterilization (QS and tubectomy) users,
Tubectomy failure rates by year of tubectomy, Vietnam
Vietnam, from January 1, 1988 to March 31, 1998
Tubectomy year
Tubectomies
Pregnancies
Failure rate
Parameter
Mean
Standard
(N )
(N )
(%)
deviation (SD)
Before 1990
323
7
2.2
Pregnancies
4.6
1.82
1990
112
0
0.0
Childbirth
3.4
1.22
1991
118
2
1.7
Induced abortion
0.56
1.00
1992
235
3
1.3
Spontaneous abortion
0.15
0.46
1993
3,118
36
1.2
Menstrual regulation (MR)
0.51
1.17
1994
2,229
29
1.3
Living children before sterilization
3.3
1.02
1995
1,467
11
0.7
Current living children
3.3
1.02
1996
1,156
10
0.9
Living sons
1.9
0.86
1997
811
3
0.4
Living daughters
1.4
1.05
1998
184
0
0.0
Total
9,753
101
1.0
Table 8
insertion for QS reported a pregnancy 26.9% of the
Failure rate for QS according to protocol used, Vietnam, 1989−1993
time. Women who had a depot medroxyprogesterone
Protocol
No.
No. pregnancy
Failure
acetate (DMPA) injection with a single insertion re-
QS users
failures
rate (%)
ported a pregnancy 4.4% of the time. Two insertions led
to women reporting pregnancy 11.7% and 3 insertions
One insertion
472
127
26.9
resulted in pregnancy 1.2% of the time. The women
Two insertions
3,068
360
11.7
who had third insertions all had MRs after their second
Three insertions
81
1
1.2
insertions because of a late period. We will return to
One insertion & DMPA a
113
5
4.4
these findings in the discussion.
Total
3,734
493
Failure of tubectomy was very low throughout the
a DMPA, depot medroxyprogesterone acetate.
decade of the 1990s (see Table 9). This is a reflection

S82
D.T. Hieu et al. / International Journal of Gynecology and Obstetrics 83 Suppl. 2 (2003) S77–S85
Table 10
Table 12
Side effects/complications after QS, Vietnam, (N = 3,740). From
Side effects/complications following 1,703 vasectomies, Vietnam.
1989 to 1993
From 1991 to 1998
Side effect/complication
N
%
Side effect/complication
N
%
Yellow vaginal discharge
373
10
Bleeding at scrotum
7
0.4
Mild pain lower abdomen
451
12.1
Hematomae
19
1.1
Others
289
7.7
Infection
20
1.2
Total
1,113
29.8
Fever
23
1.4
Pain
171
10.0
Others
55
3.2
Total
295
17.3
Table 11
Side effects/complications following tubectomy (N = 9,753), Viet-
nam. From January 1, 1988 to March 31, 1998
Side effect/complication
N
%
Table 13
Reasons for choosing vasectomy, Vietnam. From 1991 to 1998
Bleeding at the incision
57
0.58
Hematoma at the abdominal wall
20
0.20
Reason
N
%
Fever (>38ºC)
179
1.83
Simple procedure, no major surgery
666
39.2
Suppuration at the incision
210
2.15
Want to terminate childbearing
1,409
82.9
Pain at the surgical site
508
5.20
Wife cannot be sterilized
207
12.2
Others
182
1.86
Incentives will be given
91
5.4
Total
1,156
11.9
Others
75
4.2
Total
1,703
143.8
of good training and good program implementation,
including monitoring. The failure rate at the time of
the interview period was 1.0%. A lower rate is rarely
precipitously to only 49 in 1997. All districts had a
reported.
similar experience. As with female sterilization, most
Side effects and complications reported by QS users
couples were relying on the IUD just prior to the
were mild and non-threatening. They are reported
vasectomy (83%). Interestingly, in 5% of the couples,
in Table 10. None required hospitalization. All were
the wife was currently using tubectomy. Vasectomy
temporary, lasting from a few hours to a few days.
was accepted at an older age (a mean of 42.7 years)
Yellow vaginal discharge needed only genital washing,
compared to QS and tubectomy but the number of
and pain was relieved by papaverine or paracetamol
years of school completed was identical (mean of
in one or two days. On the other hand, side effects
6.6 years). Table 12 lists the complications and side
and complications of tubectomy were more serious
effects of vasectomy though none are major. They
(Table 11) but not life-threatening, and none were
affected 17.3% of the men. Table 13 shows the reasons
severe. All tubectomy patients were hospitalized for
for choosing vasectomy. A full 83% said the finality of
a week or more and antibiotics were prescribed for
the procedure made it attractive. Its simplicity and that
them. Some required additional hospitalization for
it was not major surgery appealed to 39%.
treatment of complications, which, in general, were
A total of 69 of 1,703 men who obtained a vasectomy
more serious and more expensive to manage than those
experienced a failure of the method resulting in a
seen with QS.
pregnancy for a rate of 4.1%. The outcomes of these
Vasectomy was rare before 1992 as can be seen in
71 pregnancies were as follows: childbirth 37.7%,
Table 6. In the districts studied, the number quickly
induced abortion 53.6%, spontaneous abortion 7.3%,
peaked at 912 in 1993 and then the number fell
and ectopic pregnancy 1.4%.

D.T. Hieu et al. / International Journal of Gynecology and Obstetrics 83 Suppl. 2 (2003) S77–S85
S83
4. Discussion
This study found that there was a strong preference
for QS and many women interviewed and others en-
There were many important findings in this study.
countered during the course of the study expressed their
We can now discuss QS, tubectomy and vasectomy
desire that QS be offered once more. During the course
in Vietnam authoritatively and we can compare these
of this study, many representatives of local Women’s
methods to each other. Several reasons for the startling
Unions, speaking for their constituents, strongly urged
decline in the use of sterilization in Vietnam became
the investigators to do everything possible to make QS
apparent. Unfounded rumors regarding all methods
available again.
abound. For example, many of the women believed va-
Our research demonstrates that the stage is set
sectomy would impair sexual function and discouraged
for extensive use of sterilization in Vietnam as the
their husbands. QS declined rapidly in 1993 before the
method of choice among couples who want no more
WHO letter claiming that quinacrine probably causes
children. The rate of child loss among those who sought
cancer [1]. This was mainly due to the large incentives
sterilization was found to be very low – an average
paid to patients, promoters and clinicians for surgical
sterilization which were never paid for QS. As a
of 0.1 children per couple. This is reflected nationally
consequence of these promotions, many individuals
in the contraceptive prevalence data which reveal that
sought sterilization before they were ready, and they
couples in Vietnam strongly desire to limit the size
eventually became very unhappy with their decision.
of their families. Couples have realistic expectations
These dissatisfied men and women are very poor
that their children will survive. The high contraceptive
ambassadors for sterilization and no doubt undermined
prevalence level also indicates a strong commitment by
the credibility of the program.
the government to make good contraceptive methods
This study also established that we did a poor job of
available to everyone.
introducing QS, largely because of a serious shortfall in
In the United States, nearly 80% of couples are
resources. It also confirmed that we did well technically
sterilized before the wife reaches the end of her re-
with the introduction of surgical sterilization. The
productive years. They are confident that their children
failure rate with tubectomy was a low 1% with an
will survive. This condition is now met in Vietnam,
average follow-up of more than 4 years, an acceptable
making sterilization more desirable. It is rightfully seen
rate. The failure rate with vasectomy was 4% after
as the safest and most use-effective method. Because
a similar follow-up period. Part of this rate can
of its quantum leap in use-effectiveness, sterilization
be attributed to the learning curve and this rate is
offers the opportunity to a family planning program
likely to fall with more experience. No life-threatening
to make a parallel transition in effectiveness. Family
complications were reported in this study with any of
planning programs that offer only temporary methods
the three methods.
reach a plateau where program effectiveness levels off
However, QS had a clear advantage with regard to
well below the desired point. Both sterilization and
cost-effectiveness. QS costs only US$1, while tubec-
abortion then create new potential plateaus. Abortion
tomy costs US$100 or more. By policy, 3−5 days’ hos-
is currently easily accessible everywhere in Vietnam,
pitalization were usually required with tubectomy, and
but some couples choose not to use this service for
after discharge, paid sick leave was always 7−10 days.
religious or other reasons, and do not succeed in
Complications of surgical sterilization, though not life-
limiting their family size to the desired number of chil-
threatening, were more serious than with QS. They
dren. Sterilization can also sharply reduce the demand
needed to be managed at health facilities and some of
for abortion, making the family planning program
these patients had to be hospitalized. No deaths were
more cost effective. For these reasons, accessibility to
reported in the provinces studied. However, one death
good sterilization services is an important goal for all
from tubectomy was reported in a Central Highlands
reasonable family planning programs.
province. On the other hand, QS complications only
In this retrospective study, we have documented
needed to be treated at home with simple or no
the failure of our attempt in the 1990s to make
medications. Investment costs for surgical sterilization
good sterilization services available in Vietnam. Our
are much greater than for QS, involving expenses for
purpose was to shed light on the reasons for this
personnel, training and facilities.
failure and to identify the manner in which to achieve

S84
D.T. Hieu et al. / International Journal of Gynecology and Obstetrics 83 Suppl. 2 (2003) S77–S85
program success. Two separate and very different
returned to the clinic for a third insertion following an
initiatives were undertaken in the 1990s to make safe
MR that was probably unnecessary.
and effective sterilization services available. We began
The data reported in Table 8 offer new evidence
with QS. The first study was undertaken in Nam Ha
on what was responsible for the high QS failure rate
Province in 1989 (Nam Ha was later subdivided
seen in our program. It now appears that women who
into Ha Nam and Nam Dinh Provinces) and results
missed a menstrual period returned to the clinic and
were very promising. Our second investigation was
reported that they were pregnant. They then requested
undertaken in 1990, again with good results. Then
an MR which they received. A failure of QS was then
demand quickly soared. Before long, commune clinics
recorded in their record. Given that this method was
were reporting that more than 100 women would
so new and there was no education about QS offered
line up in front of the building for QS on days it
by the government, women understandably were not
was offered. There were no government promotions
confident in its results. Most of these women were
or campaigns for QS. Unfortunately, there was no
rather desperate to avoid another child. The surest
budget for training clinicians or other clinic staff, or
treatment was an MR. As previously mentioned, no
for community information and education programs
pregnancy test was available.
or educating counselors. Individuals only knew that
The data in Table 8 support this explanation. The
they wanted their childbearing terminated and that
reported failure rate for women having only one
QS would accomplish this safely. This demand for
insertion is 26.9%. However, in a smaller series
QS services was spontaneous and from the grass roots.
undertaken to evaluate a possible potentiating effect of
It was apparent to them that QS did not harm women
DMPA, the failure rate was only 4.4% after more than
and that it usually worked. It was not clear early on
6 years. Women were made aware that DMPA caused
that these critical program shortcomings could have
amenorrhea and were not concerned that it might be a
serious negative effects on the program. It was clear
sign of pregnancy and apparently usually ignored this
that women found the QS method very attractive. For
condition. The rate of 4.4% is close to that reported
example, in one province, women were counseled both
for single insertion in some other countries, but is a
on QS and tubectomy and then given the choice of the
small fraction of 26.9%. The DMPA was shown in
two methods. For every woman choosing tubectomy,
other studies not to have a potentiating effect and has
11 chose QS. But by late 1992, it appeared that the
been abandoned for this purpose [7]. Also, Table 8
failure rate with QS was much higher than expected.
reports on the results of a three-insertion protocol.
More and more pregnancies were being reported and
These 81 women had received a third insertion after
this no doubt affected the credibility of QS with both
they had undergone an MR following 2 insertions of
clinicians and women. The reputation of the procedure
quinacrine pellets. Their failure rate of 1.2% after more
became tainted. By then we recognized that perhaps
than 6 years is in line with experiences with this three-
there were serious shortcomings in the introduction of
insertion protocol in other countries.
QS into our family planning program.
This is compelling evidence that the numbers cited
What was strongly discouraged was the use of
by Sokal and his colleagues in 2000 [5] grossly
a single insertion protocol for QS, as this usually
overstate the true failure rate of QS. The true rates
reflected poor training and monitoring of clinicians.
of pregnancy in our program are likely much closer
There was one exception. It was believed for a time that
to those seen in other countries than the rates of
the addition of a single injection of DMPA at the time
12.9% at 5 years after two insertions and 27.3% after
of the insertion may improve the efficacy of QS [6].
one insertion that he reported. We believe that the
This was later disproved [7]. However, one trial of a
training preparation for QS was inadequate and that
single insertion plus DMPA was conducted in these
the QS program was permitted to grow much too
provinces and some of these women appear in Table 8.
quickly, allowing our monitoring of the program to be
This table also shows that a significant proportion
overwhelmed. There was too little evaluation and what
of women received a single insertion without DMPA,
was undertaken was done too slowly. We also recognize
documenting that our training and program monitoring
that there should have been community information and
were deficient. The 113 women who had 3 insertions
education (I&E) programs developed and implemented.

D.T. Hieu et al. / International Journal of Gynecology and Obstetrics 83 Suppl. 2 (2003) S77–S85
S85
There should have been much more attention given to
counseled on all three so that they can then make an
counseling, with an emphasis on the side effects of QS,
informed choice with which they will be happy. We
including amenorrhea.
have learned that satisfied users of a service are the
For obvious reasons, QS is viewed in Vietnam among
most effective promoters.
providers, patients and the public in general, as failing
far more often than it actually does. There are tens
of thousands of Vietnamese women who are very
References
happy with their QS who will be supportive of the
[1] The Editors. Death of a study: WHO, what, and why. Lancet
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[2] Agoestina T, Kusuma I. Clinical evaluation of quinacrine
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[3] Guzman-Serani R, Bernales A, Cole LP. Clinical report:
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[6] Mullick BC, Kessel E, Mumford SD. A potential single insertion
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