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Vacuum aspiration with the IPAS Modified Gynecologic Syringe
CONTRACEPTION
VACUUMASPIRATICN WITH THE IPAS MODIFIED GYNECOLOGICSYRINGE
Sandor
A. Balogh
International Fertility Research Program A Program of Family Health International Research Wiangle Park, North Carolina 27709
USA
ABSTRACT The IPAS Modified Gynecologic Syringe was compared with the electric pump and standard hand pump in a clinical trial of 1227 women This modified double-valve syringe undergoing vacuum aspiration. was designed to fit larger 8 nm, 10 nsn and 12 ~lpncannulae, which are more suitable for late first trimester procedures. The study was conducted at four centers in which the double-valve syringe was used alternately with the vacuum source normally used at each clinic . Although there were notable inter-center differences with results were similar for prorespect to certain outcome variables, The only significant finding cedures performed at the same center. was the lower proportion of women requiring D & C to complete uterine evacuation among double-valve syringe patients than among The data indicate that the doublehand pump cases at one center. valve syringe is safe and effective for uterine aspiration in women up to 14 weeks’ gestation and may be preferable for use in clinics with limited facilities.
Submitted Accepted
for for
publication publication
December December
JANUARY 1983VOL. 27 NO. 1
4, 8,
1982 1982
63
CONTRACEPTION
INTRODUCTION Vacuum aspiration with the hand syringe has proven to be b safe and effective means of uterine evacuation up to eight weeks’ gestation (l-3). The procedure has been tested under a variety of In genclinical settings with minimal complications or failures. era1 , the size of cannulae used for these procedures has been 4-6 mm. The use of 8 mm, 10 mm and 12 mm cannulae would allow aspiration during the later weeks of the first trimester to be performed The IPAS* Modified Gynecologic Syringe with the same syringe. consists of a 50 cc Karman syringe that has a double locking valve which accepts adapters that can accommodate and modified nozzle, The International Fertility Research Program the larger cannulae. (IFRP, a program of Family Health International) initiated a study at four centers to compare procedures performed with the doublevalve syringe with those performed with the vacuum source normally used at each of the centers, The purpose of this paper is to present the combined results of that study. METHOD The study was conducted between May 1980 and July 1981 at four centers, two located in Bangladesh, one in Southeast Asia and one in Yugoslavia. The alternative vacuum source used at the two Bangladesh centers was a standard bicycle-type hand pump and at the Southeast Asian and Yugoslavian centers an electric pump. A total of I227 women participated in the study, of whom 606 underwent 367 were treated with the aspiration with the double-valve syringe, hand pump and 254 were treated with an electric pump. Weekly alternation of the equipment at each center determined which vacuum All data were colsource was used for a particular procedure. lected on standardized forms and sent to the IFRP for processsing and analysis . RESULTS Women in the three groups were comparable with respect to age, parity and nunber of previous induced abortions (Table I). Length of amenorrhea was calculated as the interval between onset of the Approx ilast menstrual period (LMP) and date of the procedure. mately two-thirds of the women were lo-12 weeks amenorrheic, which This corresponds to an approximate gestational age of 8-10 weeks. interval tended to be longer among the Southeast Asian patients (mean length about 92 days) and accounts for the higher average
*International
64
Projects
Assistance
Services,
Chapel
JANUARY
Hill,
NC, USA
1983 VOL. 27 NO. 1
CONTRACEPTION
among electric pump cases and to a lesser syringe cases. Women who were more than excluded from analysis .
extent the double-valve 16 weeks since LMP were
TABLE I Sociodemographic
Characteristics
---
Age (mean) Parity (mean) Previous induced abortions (s) Length of Mean Range
--
--_-Double-Valve Syringe (N = 606)
Band Pump (N = 367)
Electric Pump (N = 254
26.7 2.8
26.4 3.1
28.2 2.9
6.3
7.6
11.8
amenorrhea* 85.7 51-112
72.3 47-87
78.0 43-l 12
---I_--_-
--
-*Interval from onset (in days) .
of
last
menses
to date
of
the
procedure
Pregnancy tests prior to the procedure were administered to fewer than 5% of the women’ and only one center routinely collected uterine tissue specimens for later analysis. Among the 383 samples taken, products of conception were identified by macroscopic examination in all but two cases. In three centers no anesthetic was given and all patients were treated on an outpatient basis; general anesthesia was administered to the Yugoslavian wcxnen, and approximately 90% were hospitalized for at least one night. The majority of procedures (> 70%) were performed with an 8 mm plastic rigid cannula; similar type 10 mm Mean procedural and 12 n cannulae accounted for the remainder. times varied from center to center but were fairly consistent within each center (Table II). Only in one Bangladesh center was the difference in times significant (p < .Ol) . Immediate complications lems encountered during the
JANUARY
1983 VOL. 27 NO. 1
and complaints were defined as probprocedve or detected any time before
65
t.2 4
-
-
“P<.ol
*Excludes 7 etectric pump cases.
curettage(%)
Pelvic infection (%I
“c
p
Bleeding requiring
z
Fotlow-up
3.1
3.1
f3kXJdloss> loOld
D & C required (%I
1.0
Cervical laceration 0
% 4
c
5 4
4.2
Mean procedural time ~minutes)
Double-Vahm
y-
1.4
1.4
1.4
-
-
4.0
Ebctric Pump IN = 741
-
0.5
-
43.8
1.6
3.9
svriw (IV = IS41
Double-Valve
-
1 .J
-
45.1
2.9
4.6
EleuMc *mp IN = 173)
SEAS&
VARlABLES
TABLE II OUTCOME
-
12.0
0.9
-
-
17.7
Svrinse IN=2181
Double-Valve
0.4
12.8
33.8
-
-
22.3’
l
Hand pump W=2691
8anglatleshI’
l
l
-
3.1
100.0
-
-
14.3
WW (N = 981
Do&b-Valve
3.2
1.1
100.0
1.0
-
13.6
Hand Pump f/v = 981
Bangladesh II
CONTRACEPTION
No uterine perforations occurred the woman’s discharge (Table II). Four (0.7%) cervical lacerations were reported among in the study. the double-valve syringe group and five (2.0%) among electric pump The cause of these injuries (tenaculun or cannula) is unacases. Failure rates, as determined by the provailable from the data. portion of women for whom a second procedure was necessary, aro At one Bangladesh center D h C was routinely difficult to assess. performed following aspiration, perhaps for precautionary reasons. At the other Bangladesh center a significantly greater proportion of procedures with the hand pump required D & C following aspirathis was in part responsible tion to complete uterine evacuation; for the increased mean procedmal time observed for these cases. Failed procedures were minimal in Yugoslavia and seemingly nonexistent among the Southeast Asian group. As with procedural times there appeared to be great variation in the incidence of excessive (> 100 ml) blood loss among the four centers; although the proportions ranged from nil to nearly 50% between centers, they were comparable within centers, No transfusions were required. Other complaints included episodes of nausea and vomiting and anesthesia-related apnea, all of which occurred equally within centers. The women were requested to return for a follow-up visit approximately one month after the procedwe, and virtually 100% compliance was attained. Reports of persistent bleeding requiring curettage indicative of retained products of conception, subsequent pelvic infection, fever and complaints of light bleeding or spotting were few and occurred with nearly equal frequency among the three vacuum sources (Table II). DISCUSSION The results of this study indicate that the IPAS double-valve hand syringe with adapters for fitting 8 nxn, 10 mm and 12 mm cannulee may be used safely and effectively for uterine evacuation procedures in women up to 14 weeks! gestational age. HOweVer, it must be noted that vacuum aspiration by any method becomes incrcasingly difficult as gestation advances (2,4), The high percentage of women who suffered excessive blood loss at the Southeast Asian oenter can most likely be attributed to the late stage at whioh these procedWes were performed relative to those performed at the other three centers. There were 73 women whose gestation81 ages were between 12-14 weeks, whereas none of the women at the other centers were over 10 weeks.
JANUARY
1983 VOL. 27 NO. 1
67
CONTRACEPTION At one Bangladesh center, the double-valve hand syringe was more effective than the standard hand pump in avoiding the need for D & C immediately following vacuum aspiration to completely evacuate the uterus. This no doubt contributed to the significantly longer mean procedural time observed for the hand pump cases. There were no differences, however, between these two vacuum sources with respect to the proportion of wcmen reporting immediate or follow-up complications. There were notable differences among the centers with respect to administering anesthesia, time to complete the procedwe and certain outcome variables. These inconsistencies were due to variations in hospital policy and definition of terms, and emphasize the need for evaluating the double-valve syringe separately within each center. Overall, intra-center differences tended to be slight, although other investigators have demonstrated marked variability in complications among physicians performing vacuum aspiration (5). The double-valve syringe has the advantage of eliminating the need for electricity and/or extra manpower required for operation of the electric and hand pumps. It is a low-maintenance, relatively inexpensive and easily transportable instrument , which can also be used for uterine biopsy, the treatment of incomplete abortion and evacuation of molar pregnancies. These features, combined with its success in first trimester uterine aspiration as suggested by this study, increase its desirability for use in developing countries.
REFERENCES 1.
Karman, H. and Potts, M. Very early Lancet 1: 1051 (1972). vacuum source.
2.
van der niques.
3.
Holtrop, H.R. and Waife, family planning, 2nd ed.
4.
Liu, D.T.Y. and Hudson, mination of pregnancy. (1974).
5.
Andosek, L. and Ggrinc-Oven M. First Miller, E.R., Wood, J.L., trimester abortion by vacuum aspiration: interphysician 16: 144-149 (1978). variability. Int . J. Gynaecol. Obstet.
68
abortion
using
syringe
as
Vlugt, T. and Piotrow, P.T. Uterine aspiration techPopulation Reports, Series F, No. 3, June 1973. Uterine R.S. The Pathfinder
aspiration techniques Fund, Boston, 1979.
in
Karman cannula and first-trimester I. Am. J. Gbstet. Gynecol. 118:906-909
JANUARY
ter-
1983VOL. 27 NO. 1
VACUUMASPIRATICN WITH THE IPAS MODIFIED GYNECOLOGICSYRINGE
Sandor
A. Balogh
International Fertility Research Program A Program of Family Health International Research Wiangle Park, North Carolina 27709
USA
ABSTRACT The IPAS Modified Gynecologic Syringe was compared with the electric pump and standard hand pump in a clinical trial of 1227 women This modified double-valve syringe undergoing vacuum aspiration. was designed to fit larger 8 nm, 10 nsn and 12 ~lpncannulae, which are more suitable for late first trimester procedures. The study was conducted at four centers in which the double-valve syringe was used alternately with the vacuum source normally used at each clinic . Although there were notable inter-center differences with results were similar for prorespect to certain outcome variables, The only significant finding cedures performed at the same center. was the lower proportion of women requiring D & C to complete uterine evacuation among double-valve syringe patients than among The data indicate that the doublehand pump cases at one center. valve syringe is safe and effective for uterine aspiration in women up to 14 weeks’ gestation and may be preferable for use in clinics with limited facilities.
Submitted Accepted
for for
publication publication
December December
JANUARY 1983VOL. 27 NO. 1
4, 8,
1982 1982
63
CONTRACEPTION
INTRODUCTION Vacuum aspiration with the hand syringe has proven to be b safe and effective means of uterine evacuation up to eight weeks’ gestation (l-3). The procedure has been tested under a variety of In genclinical settings with minimal complications or failures. era1 , the size of cannulae used for these procedures has been 4-6 mm. The use of 8 mm, 10 mm and 12 mm cannulae would allow aspiration during the later weeks of the first trimester to be performed The IPAS* Modified Gynecologic Syringe with the same syringe. consists of a 50 cc Karman syringe that has a double locking valve which accepts adapters that can accommodate and modified nozzle, The International Fertility Research Program the larger cannulae. (IFRP, a program of Family Health International) initiated a study at four centers to compare procedures performed with the doublevalve syringe with those performed with the vacuum source normally used at each of the centers, The purpose of this paper is to present the combined results of that study. METHOD The study was conducted between May 1980 and July 1981 at four centers, two located in Bangladesh, one in Southeast Asia and one in Yugoslavia. The alternative vacuum source used at the two Bangladesh centers was a standard bicycle-type hand pump and at the Southeast Asian and Yugoslavian centers an electric pump. A total of I227 women participated in the study, of whom 606 underwent 367 were treated with the aspiration with the double-valve syringe, hand pump and 254 were treated with an electric pump. Weekly alternation of the equipment at each center determined which vacuum All data were colsource was used for a particular procedure. lected on standardized forms and sent to the IFRP for processsing and analysis . RESULTS Women in the three groups were comparable with respect to age, parity and nunber of previous induced abortions (Table I). Length of amenorrhea was calculated as the interval between onset of the Approx ilast menstrual period (LMP) and date of the procedure. mately two-thirds of the women were lo-12 weeks amenorrheic, which This corresponds to an approximate gestational age of 8-10 weeks. interval tended to be longer among the Southeast Asian patients (mean length about 92 days) and accounts for the higher average
*International
64
Projects
Assistance
Services,
Chapel
JANUARY
Hill,
NC, USA
1983 VOL. 27 NO. 1
CONTRACEPTION
among electric pump cases and to a lesser syringe cases. Women who were more than excluded from analysis .
extent the double-valve 16 weeks since LMP were
TABLE I Sociodemographic
Characteristics
---
Age (mean) Parity (mean) Previous induced abortions (s) Length of Mean Range
--
--_-Double-Valve Syringe (N = 606)
Band Pump (N = 367)
Electric Pump (N = 254
26.7 2.8
26.4 3.1
28.2 2.9
6.3
7.6
11.8
amenorrhea* 85.7 51-112
72.3 47-87
78.0 43-l 12
---I_--_-
--
-*Interval from onset (in days) .
of
last
menses
to date
of
the
procedure
Pregnancy tests prior to the procedure were administered to fewer than 5% of the women’ and only one center routinely collected uterine tissue specimens for later analysis. Among the 383 samples taken, products of conception were identified by macroscopic examination in all but two cases. In three centers no anesthetic was given and all patients were treated on an outpatient basis; general anesthesia was administered to the Yugoslavian wcxnen, and approximately 90% were hospitalized for at least one night. The majority of procedures (> 70%) were performed with an 8 mm plastic rigid cannula; similar type 10 mm Mean procedural and 12 n cannulae accounted for the remainder. times varied from center to center but were fairly consistent within each center (Table II). Only in one Bangladesh center was the difference in times significant (p < .Ol) . Immediate complications lems encountered during the
JANUARY
1983 VOL. 27 NO. 1
and complaints were defined as probprocedve or detected any time before
65
t.2 4
-
-
“P<.ol
*Excludes 7 etectric pump cases.
curettage(%)
Pelvic infection (%I
“c
p
Bleeding requiring
z
Fotlow-up
3.1
3.1
f3kXJdloss> loOld
D & C required (%I
1.0
Cervical laceration 0
% 4
c
5 4
4.2
Mean procedural time ~minutes)
Double-Vahm
y-
1.4
1.4
1.4
-
-
4.0
Ebctric Pump IN = 741
-
0.5
-
43.8
1.6
3.9
svriw (IV = IS41
Double-Valve
-
1 .J
-
45.1
2.9
4.6
EleuMc *mp IN = 173)
SEAS&
VARlABLES
TABLE II OUTCOME
-
12.0
0.9
-
-
17.7
Svrinse IN=2181
Double-Valve
0.4
12.8
33.8
-
-
22.3’
l
Hand pump W=2691
8anglatleshI’
l
l
-
3.1
100.0
-
-
14.3
WW (N = 981
Do&b-Valve
3.2
1.1
100.0
1.0
-
13.6
Hand Pump f/v = 981
Bangladesh II
CONTRACEPTION
No uterine perforations occurred the woman’s discharge (Table II). Four (0.7%) cervical lacerations were reported among in the study. the double-valve syringe group and five (2.0%) among electric pump The cause of these injuries (tenaculun or cannula) is unacases. Failure rates, as determined by the provailable from the data. portion of women for whom a second procedure was necessary, aro At one Bangladesh center D h C was routinely difficult to assess. performed following aspiration, perhaps for precautionary reasons. At the other Bangladesh center a significantly greater proportion of procedures with the hand pump required D & C following aspirathis was in part responsible tion to complete uterine evacuation; for the increased mean procedmal time observed for these cases. Failed procedures were minimal in Yugoslavia and seemingly nonexistent among the Southeast Asian group. As with procedural times there appeared to be great variation in the incidence of excessive (> 100 ml) blood loss among the four centers; although the proportions ranged from nil to nearly 50% between centers, they were comparable within centers, No transfusions were required. Other complaints included episodes of nausea and vomiting and anesthesia-related apnea, all of which occurred equally within centers. The women were requested to return for a follow-up visit approximately one month after the procedwe, and virtually 100% compliance was attained. Reports of persistent bleeding requiring curettage indicative of retained products of conception, subsequent pelvic infection, fever and complaints of light bleeding or spotting were few and occurred with nearly equal frequency among the three vacuum sources (Table II). DISCUSSION The results of this study indicate that the IPAS double-valve hand syringe with adapters for fitting 8 nxn, 10 mm and 12 mm cannulee may be used safely and effectively for uterine evacuation procedures in women up to 14 weeks! gestational age. HOweVer, it must be noted that vacuum aspiration by any method becomes incrcasingly difficult as gestation advances (2,4), The high percentage of women who suffered excessive blood loss at the Southeast Asian oenter can most likely be attributed to the late stage at whioh these procedWes were performed relative to those performed at the other three centers. There were 73 women whose gestation81 ages were between 12-14 weeks, whereas none of the women at the other centers were over 10 weeks.
JANUARY
1983 VOL. 27 NO. 1
67
CONTRACEPTION At one Bangladesh center, the double-valve hand syringe was more effective than the standard hand pump in avoiding the need for D & C immediately following vacuum aspiration to completely evacuate the uterus. This no doubt contributed to the significantly longer mean procedural time observed for the hand pump cases. There were no differences, however, between these two vacuum sources with respect to the proportion of wcmen reporting immediate or follow-up complications. There were notable differences among the centers with respect to administering anesthesia, time to complete the procedwe and certain outcome variables. These inconsistencies were due to variations in hospital policy and definition of terms, and emphasize the need for evaluating the double-valve syringe separately within each center. Overall, intra-center differences tended to be slight, although other investigators have demonstrated marked variability in complications among physicians performing vacuum aspiration (5). The double-valve syringe has the advantage of eliminating the need for electricity and/or extra manpower required for operation of the electric and hand pumps. It is a low-maintenance, relatively inexpensive and easily transportable instrument , which can also be used for uterine biopsy, the treatment of incomplete abortion and evacuation of molar pregnancies. These features, combined with its success in first trimester uterine aspiration as suggested by this study, increase its desirability for use in developing countries.
REFERENCES 1.
Karman, H. and Potts, M. Very early Lancet 1: 1051 (1972). vacuum source.
2.
van der niques.
3.
Holtrop, H.R. and Waife, family planning, 2nd ed.
4.
Liu, D.T.Y. and Hudson, mination of pregnancy. (1974).
5.
Andosek, L. and Ggrinc-Oven M. First Miller, E.R., Wood, J.L., trimester abortion by vacuum aspiration: interphysician 16: 144-149 (1978). variability. Int . J. Gynaecol. Obstet.
68
abortion
using
syringe
as
Vlugt, T. and Piotrow, P.T. Uterine aspiration techPopulation Reports, Series F, No. 3, June 1973. Uterine R.S. The Pathfinder
aspiration techniques Fund, Boston, 1979.
in
Karman cannula and first-trimester I. Am. J. Gbstet. Gynecol. 118:906-909
JANUARY
ter-
1983VOL. 27 NO. 1