|
Safety & Reliability
Has Ladycomp / Babycomp been investigated
by specialists in this field (about safety)?
Yes, Babycomp and Ladycomp were submitted for several independant
clinical tests and studies.
1998 contraception safety of Babycomp and Ladycomp was tested
with 686 women over 2 years; the result: Pearl-Index 0,7.
The first time Prof. Dr. med. G. Freundl from Germany tested
Babycomp, it was on 20 women in the course of 199 cycles. Here
is his summary of this pilot study to determine the fertile days
in a woman's cycle.
Babycomp for natural family planning: Many couples are looking
for a method of family planning that does not involve the use
or intake of artificial substances. They try to judge the cyclic
fertility of the woman by observing body signals and adapt their
sexual behaviour (intercourse or no intercourse) in their efforts
to avoid or plan a pregnancy. The so-called natural family planning
methods, which in the past could only provide women with relatively
unreliable information, now offer very reliable possibilities
to achieve this aim.
With regard to reliability we can recommend two methods at the
present time: first, the basal body temperature method and second,
the symptothermal method. The former establishes information about
a woman's fertility or infertility based on the observation of
the cyclic course of the woman's basal body temperature. In addition
to analysing the basal body temperature, the latter examines the
mucus in the neck of the womb. Both methods require the user to
learn and adhere to very specific rules developed in the course
of long-term research.
The strict observance of these rules ensures that the method
reliability corresponds to 0.5 and 1 on the Pearl Index with the
actual reliability in use amounting to between 1 and 2.8 on the
Pearl Index. In prospective research to establish the reliability
of the aforementioned methods, we, at the University of Düsseldorf,
were able to confirm these figures as part of a research project
on natural family planning.
Many women, however, felt that learning and applying the appropriate
rules on a daily basis was too much trouble, too time-consuming
and too complicated. With this in mind microcomputers were developed
and programmed to contain the rules for the temperature method.
A sophisticated evaluation programme enables them to display the
statement fertile or infertile on the appropriate days.
Babycomp is such a device. We have tested Babycomp on 20 women
in the course of 199 cycles. The results proved that this device
provides many women with valuable assistance in their efforts
to increase their knowledge of their individual cycle and assess
their level of fertility. Naturally it does not eliminate the
need for abstinence if a pregnancy is to be avoided.
The device also takes a great number of particular situations
into consideration in its programme. Compared with other natural
methods requiring considerable learning, I consider Babycomp to
be a very good and highly recommendable alternative for couples
who feel at home with modern appliances and prefer to limit interventions
in the body functions to a minimum. It goes without saying that
a computer is only as good as the theory that it is based on,
in this case the basal body temperature method.
The fact that it is however better in its overall results can
be explained by the reduction in human error when using this device.
I would therefore like to see this device widely used. It will
certainly live up to its expectations. Naturally it is nevertheless
important to recognise the limitations of technology and to consult
an experienced doctor or counsellor in the event of uncertainty.
Signed by Prof. Dr. G. Freundl.
Original text by Prof. Dr. med. habil. Günter Freundl, Senior
Consultant at the Gynaecological Clinic of Düsseldorf-Benrath
Municipal Hospital, Urdenbacher Allee 83, D-40593 Düsseldorf,
Germany.
How reliable is Ladycomp/Babycomp in comparison with other methods
of contraception?
The reliability of a method of contraception is expressed in the
medical profession by the Pearl Index. The Pearl Index indicates
how many unwanted pregnancies occur in 100 user years. A contraceptive
pill with a Pearl Index of 1 means that if 100 women use this
pill for contraception for one year, one woman will nevertheless
get pregnant during this time.
The Pearl Index of a specific method of contraception is determined
by means of large-scale surveys. The scope of such surveys requires
the observation of approx. 20,000 cycles.
The development of Ladycomp/Babycomp was able to benefit from
the fact that thousands of women had already been using the temperature
method for years and had therefore been compiling their charts
and data It was possible to save this information on magnetic
disks together with data concerning exceptionally difficult cycles
from text books and the archives of research institutes.
The Ladycomp/Babycomp programme was required to evaluate these
cycles again and again. If it made mistakes, it was corrected
until it was able to evaluate all cycles accurately.
Up to January 1996 the Ladycomp/Babycomp programme was able to
prove its reliability by accurately evaluating approx. 700,000
cycles for approx. 20,000 users. The device has therefore fulfilled
the requirements of the Pearl Index already ten times over.
Clinical research led by Prof. Dr. med. G. Freundl in Düsseldorf
confirm the reliability of this device (see answer to question
2).
If Ladycomp/Babycomp shows "green", the likelihood
of a pregnancy less than when taking the pill (Pearl Index = 0.6-
0,7).
d.
|