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Description  |
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BACKGROUND AND SUMMARY OF THE INVENTION
This invention relates in general to the field of obstetrics and, more
particularly, to an instrument for induction of labor as well as a method
for inducing labor.
Methods for induction of labor are divided into two primary categories,
namely medical and mechanical. The particular method depends upon the
condition or state of the involved organs with respect to delivery. The
medical method would be the method of choice when the cervix is in a fully
matured, loose condition and the uterus sensibility is heightened, or when
the cervical orifice has dilated more than the width of two fingers. Only
an intermittent intramuscular injection of posterior pituitary extract or
an intravenous drip is adequate, in most cases, to assure a successful
delivery. If with such conditions an artificial rupture of the amniotic
membrane is effected, a more certain result can be obtained. However, when
the cervix has not reached a state of maturity the medical method is not
effective. Thus, to practice a medical method the particular organs must
have reached a predetermined condition of potential delivery readiness.
Without such even increased amounts of medication are insufficient to
induce labor. Therefore, the medical method has recognized limitations and
can only be used under certain conditions.
The mechanical method is employed when induction of labor is necessary in
those situations wherein the particular organs have not reached the level
of delivery readiness as would indicate resort to the medical method.
Among the more well known mechanical methods are the Bougierung method,
being the induction of an instrument for dilating constricted areas;
metreurysis, being a dilatation of the uterine cervix with a metreurynter,
and colpeurysis, involving a mechanical dilatation of the vagina. However,
such methods have not in practice by any means proved infallible and thus
the results obtained have been quite uncertain. In many cases resort has
necessarily been made to cesarean section in an effort to save the child.
It is commonly recognized that when the death rates of the full and frank
presentation and the footling presentation are compared, the prognosis for
a sound delivery is more unfavorable in the latter presentation. Such
prognosis has heretofore led to the view that delivery of footling
presentation, whether single or double, should preferably be effected by
cesarean section. Despite the stages of development of both types of
methods, medical and mechanical, certain types of birth have not proved
reliable by either method.
Therefore, it is an object of the present invention to provide an
instrument for inducing labor which is useful regardless of the
presentation of the fetus thereby being productive of a diminution of the
death rate with certain types of births which had been considered
particularly hazardous heretofore.
It is another object of the present invention to provide an instrument of
the character stated the use of which markedly reduces the heretofore
accepted necessity to the resort to cesarean section.
It is a still further object of the present invention to provide an
instrument of the character stated which has been extensively tested so
that its effectiveness is established.
It is another object of the present invention to provide an instrument of
the character stated which may be easily utilized by a practitioner with
limited instruction.
It is a still further object of the present invention to provide a method
for inducing labor which promotes a most substantial degree of sound
deliveries without peril to the fetus despite the manner of presentation
of the fetus.
It is a further object of the present invention to provide an instrument
for the induction of labor which is not harmful to the mother and thus may
be used with safety.
It is another object of the present invention to provide an instrument for
the induction of labor which may be most economically manufactured; which
is most durable in usage; and the practice of the same has promoted a
level of reliability hitherto unknown through the performance of the
customary medical and mechanical methods.
The present invention comprehends, in essence, a tubular body as a catheter
type having an inflatable balloon or bag fixed on the normally forward or
leading end of the catheter and enclosing the adjacent portion of the
catheter which is provided with a port or orifice for discharge
therethrough of a compatible liquid, such as, sterile saline solution, or
even water, into the balloon for inflating same with a predetermined
volume of such liquid dependent upon the presentation of the fetus. The
instrument is inserted between the uterus wall and the amniotic membrane
through the cervical orifice and after such insertion the liquid is
gradually fed into the balloon through the catheter portion to a
predetermined limit if there is head presentation to avoid the danger of
prolapse of the umbilical cord or the possibility of a change of position
of the fetus. In the event there is a breech presentation, the amount of
liquid introduced into the balloon is in greater amount for purposes
presently appearing. At the appropriate juncture the instrument is
automatically removed by dropping through the cervical orifice.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of an instrument for the induction of labor
constructed in accordance with and embodying the present invention.
FIG. 2 is a side view of another form of instrument for induction of labor
constructed in accordance with and embodying the present invention.
FIG. 3 is a side view of a further form of instrument for induction of
labor constructed in accordance with and embodying the present invention.
FIG. 4 is a side view of a still further form of instrument for induction
of labor constructed in accordance with and embodying the present
invention.
FIG. 5 is a side view of the instrument illustrated in FIG. 1 but showing
the balloon in expanded state.
DESCRIPTION OF PRACTICAL EMBODIMENTS
Referring now by reference numerals to the drawings which illustrate
practical embodiments of the present invention, 1 indicates a catheter or
tubular member being closed at its normally forward or leading end and
being provided with one or more ports or orifices 3 adjacent to but spaced
from the forward end extremity 2. Said catheter 1 may be molded of any
suitable flexible and durable material, such as, soft synthetic resin,
natural or synthetic rubber or the like. Enclosing the forward end portion
of catheter 1 is a relatively thin walled balloon or inflatable bag 4
fabricated as of natural or synthetic rubber and being suitably sealed at
its rearward or trailing end, such as by means of a pouch with the outer
wall of catheter 1 so as to render the joint therebetween leakproof. It
will be seen that openings 3 are within balloon 4 so that liquid fed
through catheter 1 will be received within said balloon. Balloon 4 is of
such size that its forward end 5 is spacedly forwardly of extremity 2 of
catheter 1 so as to cause the development of a limited spacing 6
therebetween so that other than the sealing of balloon 4 to catheter 1, as
above described, there is no engagement therebetween. At its rearward end
or trailing extremity, catheter 1 is provided with a removable plug 7.
The instrument of the present invention is preferably utilized after the
practitioner has determined that the cervix is mature for delivery. There
are three critical points to indicate the degree of cervical maturation,
namely the extent of cervix effacement, the degree of dilatation of the
cervical orifice, and the degree of softness of the cervix. Thus, with the
present instrument it is requisite to confirm that the cervix effaces more
than 50 percent; that the cervical orifice has dilated to a width greater
than two centimeters, and that the cervix is soft. Disregard of these
conditions in that the instrument is utilized before the requisite level
of maturity has been reached could result not only in the delay of
delivery, but also that the delivery progresses with the cervical orifice
in a nonfully dilated state even after the instrument has dropped through
the cervical orifice. With the cervical orifice not fully dilated,
extraction of the head, as well as assisted delivery of the shoulder and
arms, is difficult to carry out.
The instrument, after sterilization through boiling, in inserted by the
doctor between the uterine wall and the amniotic membrane through the
cervical orifice is substantially the same manner as Bougierung. In the
act of insertion the doctor places the leading extremity 2 of the catheter
1 at the cervical orifice holding the balloon 4 and then inserts catheter
1 moving his fingers backwardly until he senses that the instrument has
been inserted to a desired extent. Thereafter, with plug 7 removed the
doctor then pours into the rearwardly open end of catheter 1 on a gradual
basis a suitable liquid, such as, sterile saline solution, for flow into
balloon 4 via openings 3, as by means of a 100 g injector. In the case of
head presentation of the fetus, 300 cc-350 cc of the solution is
introduced into the balloon 4 causing expansion of the same as generally
illustrated in FIG. 5. The rearward end of catheter 1 is then closed by
reinsertion of plug 7 and the rearward portion of catheter 1 is coiled in
the vagina. Any traction by a weight is not utilized. As indicated above,
the limitation of the injection to no more than 350 cc in the case of head
presentation is to avoid a danger of prolapse of the umbilical cord or
shoulders and arms, or difficulties which might arise through a change of
the fetal position. In the event that the fetus is breech presented, then
more than 400 cc of the sterile saline solution is injected into the
balloon 4 with consequent commensurate expansion of the same.
After insertion of the instrument of the present invention labor commences
in about one hour on average. The cervical orifice dilates almost
completely in 7 to 8 hours in the case of a primipara, and in 4 to 5 hours
in the case of a multipara. Upon such dilation the instrument of the
present invention will drop through the cervical orifice and into the
vagina for facile removal. At this particular stage labor becomes weak for
a limited interval so that after an internal examination the instrument is
removed. If the labor continues weak, a citravenous drip of oxytoxin is
given to the pregnant woman. If the labor grows strong again, an
artificial rupture of the amniotic membrane is performed after full
confirmance of the complete dilation of the cervical orifice. Thereafter
delivery proceeds rapidly.
The instrument of the present invention can thus induce labor most
effectively. Eighty instances of employment of the present instrument has
demonstrated that its use has seldom any ill effect and that it could
achieve the intended purpose even in those cases where medicine was
incapable of inducing labor. The instrument of this invention can be used
most efficaciously as a mechanical method for delivery in the last stage
of pregnancy and has been often employed in cases of breech presentation,
especially of footling presentation, which is one of the greatest causes
of infant death during pregnancy. The prognosis of successful birth in
footling presentation has been found most favorable if no premature
rupture of the membrane has taken place, and the cervical orifice has
fully dilated. If the method of this invention is applied at the
appropriate juncture the prognosis as to birth is substantially the same
as in the case of full and frank presentation thereby obviating the
heretofore customary resort to cesarean section; but with the proviso that
no joint disease is present. Thus, the use of the present instrument makes
it possible to perform a planned delivery of footling presentation with
remarkably decreased possibility of infant death. Actually, the
utilization of the present instrument greatly diminishes most of the
heretofore accepted risks in delivery of breech presentation, such as
through prolapse of the umbilical cord and the difficulty in extracting
the fetal head before complete dilation of the cervical orifice. Thus, by
the present invention, in footling presentations, full dilation of the
cervical orifice and the soft parturient canal is substantially effected,
with the greatest advantage being the facilitation of an assisted delivery
of shoulder and arms and withdrawal of the following head. Additionally,
the use of this invention can prevent a premature rupture of the membrane
as well as a premature prolapse of the umbilical cord. A further advantage
resides in the fact that it makes a planned delivery possible so that
delivery can be effected even while a hospital is in a highly active state
with extreme demands upon its personnel.
Thus, the present method as practiced in conjunction with breech
presentation involves the dilation of the cervical orifice almost
completely; requiring induction of about 500 ml of sterile solution into
the balloon 4. A general type of metreurysis as heretofore known is
inadequate to bring about the foregoing results.
Without the use of the instrument of the present invention the prolapse of
the umbilical cord which often accompanies the footling presentation,
especially in a primipara, will inevitably require a cesarean section.
Turning now to FIG. 2, another form of instrument for induction of labor is
shown wherein like components as those incorporated within the instrument
shown in FIG. 1 are identified by like reference numerals for purposes of
brevity. The difference between the structure shown in FIG. 2 and that
shown in FIG. 1 is that the former is devoid of the spacing 6 so that the
front end extremity 2 of catheter 1 is pressed tightly into the adjacent
portion of balloon 4. With the use of the instrument shown in FIG. 2, as
the same is inserted into the cervical canal by the practitioner's
fingers, the engaged end extremity 2 and the confronting portion of
balloon 4 will move together so that during such travel ballon 4 can be
inserted into the cervical canal without any relative or irregular
movement between catheter 1 and balloon 4. With the structure of FIG. 1
the spacing 6 manifestly denies a snug joint between catheter 1 and
balloon 4 so that the latter is prone to be inserted in a biased fashion
into the cervical canal as the doctor guides same with his fingers and to
thus be expanded as in an asymmetrical manner with respect to catheter 1
as the sterile saline solution is introduced into balloon 4 through
openings 3. Thus, the form of the instrument shown in FIG. 2 overcomes, in
practice, the possibility of balloon 4 being expanded in asymmetrical
fashion with respect to catheter 1. In most conditions this difference
would not be significant but in certain conditions it is preferable that
the balloon 4 when being inserted into the cervical canal be in a
symmetrical state as shown in FIG. 2 so that no unnecessary pain might be
caused the patient. By this form of the instrument a doctor may perform
delivery with a more reliable technique as the condition merits.
The efficacy of the instrument of the present invention and of the method
for inducing labor, as above described, may best be understood by resort
to the following which sets forth results, in substantially tabulated
form, of actual clinical investigation.
(1) Rate of Effectiveness:
The ideal use of the present instrument is in dilating the cervical orifice
to such a degree that the fetus can be delivered in a natural state. Of
the 313 cases shown in Table 1, 12 cases were not considered fully
successful. These omitted cases comprise one abdominal cesarean section
due to the rigidity of the cervical orifice (a primipara of 38 year old
woman), nine uterus orifice incisions and two craniotomies. Excluding the
abdominal cesarean section which was performed as a test delivery
considering the possibility that the rigidity of the cervical orifice
loosened rapidly after the beginning of labor, six of nine cases of the
cervical orifice incision were performed for breech presentation,
especially for footling presentation. The craniotomies were performed to
lessen the pain of pregnant women, whose fetus had died while in the
uterus. These cases cannot necessarily be said to have been unsuccessful.
It can be said that the desired purpose of the instrument was achieved as
it helped dilate the cervical orifice to such an extent that those
treatments could be given. As seen from Table 1, the rates of success were
100%, 100% and 96.1%, respectively, in deliveries of 8 months, 9 months,
and 10 months.
TABLE 1
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Rate of Effectiveness
Rate of
Month of Pregnancy
Number of Cases
Success Effectiveness
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VIII 3 3 100
IX 5 5 100
X 305 293 96.1
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(2) Indications:
Table 2 shows ninety-five cases of cephalopelvic disproportions (47.5% of
head presentations), including postmature infants and contracted pelvises,
which were expected to make the delivery through a vaginal route
impossible if the infants heads grew larger, thirty-three cases of
premature rupture of the membrane which were not ready for delivery or to
which a medical method was not effective; twenty-six cases of toxemias of
pregnancy; twenty-two cases of so-called "postponement of the expected
date" in accordance with the wish of pregnant women (however, delivery
operation should not be done before the conditions for delivery are
perfect); fourteen cases of social adaptations (for example, for women who
live far from the hospital and are not in time for a hospital treatment
after the labor has begun or who have already experienced a precipitate
labor); four cases of hydraminios; three cases of death of infant while in
the uterus and each one case of twins, hemicephalus and hydrocepharus.
All the above cases, except the postponements of the expected date are
those in which the cervix had not shortened and the cervical orifice had
dilated only one finger wide, and there was no hope for a natural labor
for a while without giving any treatment and a medical method was believed
to be incapable of inducing labor.
TABLE 2
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Indications
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Cephalopelvic Disproportion
95
Premature Rupture 33
Toxemias of Pregnancy 26
Postponement of the Expected Date
22
Social Adaptations 14
Hydramnios 4
Death While in the Uterus 3
Others:
Twins 1
Hemicephalus 1
Hydrocephalus 1
Breech Presentations:
full and frank presentation
71
footling presentation 42 113
TOTAL 313
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The above breech presentations consist of seventy-one cases of full and
frank breech presentations and forty-two cases of footling presentation.
In recent years, the inventors' hospital has applied the present
instrument to cases of breech presentation, in particular to those cases
of footling presentation. The chief cause of the death of an infant in
breech presentation in said hospital has been footling presentation. The
footling presentation is apt to cause a premature rupture of the membrane
by which the small parts of an infant descend before the cervical orifice
has dilated fully and it makes it impossible to deliver the following
head. That is the greatest reason why the footling presentation brings
about the death of an infant. It has been found that the instrument for
induction of labor according to the present invention can prevent the
infant death due to the footling presentation. The present instrument,
when inserted into the cervical canal not only helps induce labor but also
works as a bag of water to prevent premature rupture of membrane and also
the prolapse of foot portions. Because the cervical orifice dilates almost
completely when the instrument drops from it, the later delivery can
proceed easily. Indeed, the rate of death due to to footling presentation
decreased remarkably after the present instrument was introduced. More
particularly, there has been no death due to the footling presentation for
the last three years.
In nine cases of full and frank breech presentations, the fetal position,
which was in footling presentation when the instrument was inserted,
changed into complete breech presentation. This fact demonstrates an
important advantage of the use of the present instrument.
(3) The Number of Times of Child-Birth and the Time Required for Delivery:
The present instrument was applied to three hundred and five delivery cases
of ten-month pregnant women. Excepting fifteen abdominal cesarean
sections, nine cervical orifice incisions and two craniotomies, the
remaining two hundred and seventy-nine cases consist of one hundred and
sixty-five cases of primiparae and one hundred and fourteen cases of
multiparae. In the former cases the time required to cause labor after
insertion of the present instrument was 3 hours and 19 minutes. In the
latter cases, it was 3 hours and 46 minutes.
However, the time required for delivery is as shown in Table 3. In the case
of head presentation, the primiparae required 12 hours and 27 minutes, and
multiparae 6 hours and 58 minutes. In the case of breech presentation, the
primiparae required 9 hours and 30 minutes, and the multiparae 6 hours and
3 minutes. These figures show that each time for delivery, when the
present instrument was used, is shorter than the time required for
delivery after natural labor. In the case of natural labor, the head
presentation and the breech presentation are little different in the time
required for delivery, but, when the present instrument is used, the head
presentation delivery requires less time. That is probably because of the
greater amount of sterile saline solution that should be introduced into
the balloon in the case of breech presentation.
TABLE 3
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Time Required for Delivery
PRIMIP-
ARA
PRES- of
ENTA- MULTIP- NATURAL THE PRESENT
TION ARA LABOR INSTRUMENT
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Head Primipara 16 hours 30 minutes
12 hours 27 minutes
Multipara 10 hours 42 minutes
6 hours 58 minutes
Breech Primipara 16 hours 12 minutes
9 hours 30 minutes
Multipara 10 hours 0 minutes
6 hours 3 minutes
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(4) As labor becomes weak after the instrument has dropped into the vagina,
posterior pituitary hormone and an artificial rupture of the membrane are
often used together.
Table 4 shows whether or not other treatments were jointly given in one
hundred and eighty-two cases of head presentation and one hundred and
eight cases of breech presentation. The cases of abdominal cesarean
section are omitted.
TABLE 4
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Posterior Pituitary Hormone and
An Artificial Rupture of the Membrane
Artificial Rup-
Natural Rupture
ture of the
of the Membrane
Membrane After
After the Instru-
the Instrument
Premature
ment Has Dropped
has Dropped Out
Rupture of
Out of the Cervical
of the Cervical
the Membrane
Canal Canal Total
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HEAD PRESENTATION
Intermittent
13 12 51 76
Cutaneous
Injection 119(65.4%)
Intravenous
7 6 30 43
Drip
No Injection
12 9 12 63 (31.6%)
TOTAL: 32 27 123 182
BREECH PRESENTATION
Intermittent
5 16 21 42
Cutaneous
Injection 72(66.7%)
Intravenous
5 16 9 30
Drip
No Injection
7 14 15 36 (33.3%)
TOTAL 17 46 45 108
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As seen from the above table, in the case of head presentation, the
intermittent cutaneous injection of atonine 0 was applied to seventy-six
cases and the intravenous drip to forty-three cases (total 119 cases,
65.4%); in the case of breech presentation, the intermittent cutaneous
injection to forty-two cases and the intravenous drip to thirty cases
(total 72 cases, 66.7%). The artificial rupture of the membrane was, in
the case of head presentation, applied to one hundred and twenty-three
cases (82.0%) in one hundred and fifty cases except the cases of premature
rupture of the membrane; and, in the case of breech presentation, it was
applied to forty-five cases (49.5%) in ninety-one cases. It can be said
that the artificial rupture of the membrane is applied to nearly every
case of head presentation after the present instrument has dropped into
the vagina. Such results since the artificial rupture of the membrane
maintains the fetus' head stable and the fore part of the instrument
provides mechanical stimuli directly to the lower part of the uterus to
promote labor and also serves to prevent prolapse of the umbilical cord or
shoulder and arms. However, the artificial rupture of the membrane is not
used as often in breech presentation as in head presentation, since,
though in the cases of full and frank breech presentations, the membrane
is ruptured as in head presentation, it is preferable to await a natural
rupture of the membrane as long as possible in the case of footling
presentation if only a little of the cervical orifice edge remains.
(5) Treatments Required After the Instrument Has Dropped From the Cervical
Canal:
As shown in Table 5, cesarean section was performed in eleven cases (5.7%)
among all the cases of head presentation. Eight such cases were of
cephalopelvic disproportion, in which delivery through the vaginal route
was considered impossible in view of the results of test delivery. The
remaining three cases were, respectively, of a placenta previa, face
presentation, and an eye disease (with danger of loss of sight in one eye
and detached retina of the other eye). In the case of breech presentation,
cesarean section was performed in four cases; two cases of which were
contracted pelvis and one was of a postmature infant with the remaining
one being of rigidity of the cervical orifice (primipara of a 38 year old
woman).
TABLE 5
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Treatments After the Instrument Has
Dropped From the Cervical Canal
HEAD PRE- BREECH PRE-
SENTATION (193 Cases)
SENTATION (112 Cases)
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Cesarean Section
11(5.7%) Cesarean Section
4(3.6%)
After-Coming Head
Forceps-Operation
7(3.6%) Forceps 5(4.5%)
Vacuum-Extraction
16(8.3%) Vacuum-Extraction
4(3.6%)
Craniotomy 2(1.0%) of the Coxae
Incision of Cervical
3(1.6%) Incision of Cervical
6(5.4%)
Orifice Orifice
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Next, in the head presentation cases, forceps, vacuum extraction and
craniotomy were used, respectively, with the percentages of 3.6%, 8.3% and
1.0%.
Incision of the cervical orifice was effected in 1.6% of the head
presentation cases and in 5.4% of the breech presentation cases. In the
latter cases, the operation was performed in almost every footling
presentation. It is to be expected, in the case of footling presentation,
that the problem will be solved by introducing a greater amount of sterile
saline solution into the balloon.
(6) Unsuccessful Births:
As the conditions of each presentation are different, there have been
certain situations wherein the use of the present instrument and the
method of use were unsuccessful.
TABLE 6
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Unsuccessful Births
Present Head Breech
Instrument
Presentation
Presentation
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Rate of Infant Death
3.0% 7 (3.7%) 2 (1.8%)
Prolapse of the
4.6% 8 (4.1%) 6 (3.1%)
Umbilical Cord
Prolapse of Shoulder
1.3% 3 (1.5%)
and Arms
Fever 0.3% 1 (0.5%) 0
Change of Infant
0 0 0
Position
(Shoulder
Presentation)
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The number of cases of infant death when efforts were made to use the
present instrument totaled nine (3%) in 301 cases of 10-month pregnancy,
except four cases including two deaths while in the uterus, one
hydrocephalus and one hemicephalus. In the nine cases, head presentation
formed 3.7% and breech presentation 1.8%, and consisted of four cases of
prolapse of the umbilical cord, two cases of breech presentation, two
cases of hemorrhage in cranium and one case of lacenta dysfunction
syndrome.
A total of eight cases (4.1%) of prolapse of the umbilical cord and three
cases (1.5%) of prolapse of shoulder and arms were encountered in one
hundred and ninety-three cases of head presentation. When the instrument
according to the present invention was first used, the amount of sterile
saline solution poured into the balloon was limited to about 300-350 cc.
The results in eighty cases at that time showed no prolapse of the
umbilical cord or shoulder and arms. Later on, in order to shorten the
time for delivery, the amount of solution was increased to 400 cc, and
with such amount, in head presentation, prolapse of the umbilical cord or
shoulder and arms became relatively more frequent. At the present time,
the amount is limited to 350 cc in the case of head presentation. As it is
possible to conjecture the time the balloon drops from the cervical
orifice because the labor, which has been strong, becomes weak rapidly,
the balloon is then removed before it would be expelled from the vagina
and the fetal head is maintained stable by means of artificial rupture of
the membrane after confirming whether the umbilical cord or shoulder and
arms prolapse or not. Even if prolapse is found, it is quite easy to
return such to their correct position at this stage.
There were four infant deaths in eight cases of prolapse of the umbilical
cord in head presentation. In each of the four cases, premature rupture of
the membrane took place. In most cases of premature rupture of the
membrane, labor does not become weak when the balloon drops from the
cervical canal into the vagina and the fetal head falls into the breech.
This often causes a doctor to fail to find the prolapse of the umbilical
cord. It is not seldom that he doesn't notice it until the heart sound of
an infant has stopped. So the present instrument should be applied to the
cases of premature rupture of the membrane only when a medical method is
not effective, and the amount of sterile saline solution to be introduced
into the balloon should be no more than 300 cc. Further a doctor should do
an internal examination frequently to be able to find the prolapse of the
umbilical cord without fail.
In the case of breech presentation, prolapse of the umbilical cord was
found in six cases (3.1%) in 112 cases. More particularly, it was found in
two cases of complete presentation and in four cases of footling
presentation. The cause of the prolapse of the cord in those cases did not
necessarily result from the method of using the present invention as such
can be seen from the fact that there were no infant deaths.
Fever of the mother due to infection was seen in one case (0.3%) in three
hundred and five cases. The rate was very low, and the fever abated after
delivery. Further, no change of an infant position was caused by the use
of the instrument of the present invention.
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