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Volume 153 Number 2
Spermicidal contraceptives and poor reproductive outcomes
To the Editors: The recent Clinical Opinion article, "Spermicidal con
traceptives and poor reproductive outcomes: The epidemiologic evidence against an association," by Dr. Bracken (AM J OBSTET GYNECOL 1985;151:552), is most reassuring with respect to the safety of spermicide contraceptives. However, the following report appeared in the Los Angeles Times, January 24, 1985:
A federal judge ruled that a widely used spermicide caused birth defects in a girl and ordered the manufacturer to pay $5.1 million in damages to the child and her mother. U.S. District Judge Marvin Shoob ruled in Atlanta that Ortho Pharmaceutical Corp. of Raritan, N.J., which makes Ortho-Gynol Contraceptive Jelly, should have warned its users that birth defects can result from conceptions that the gel fails to prevent. Expert Witnesses for the plaintiffs, Mary Maihafer and her daughter, Mary Wells, 3, testified that the gel can damage sperm while failing to kill it.
Is this just another example of the lack of concordance between the practice of law and the practice of medicine? Will this judgment perhaps be reversed on appeal in the event Dr. Bracken becomes one of the testifying expert witnesses? If the aforementioned award is in fact given and not appealed, or perhaps confirmed on appeal, what does that say about legal precedent so established, irrespective of the data presented by Dr. Michael Bracken?
Sylvain Fribourg, M.D. * Obstetrics and Gynecology Department Kaiser Permanente Southern California Permanente Medical Group 13652 Cantara Street Panorama City, California 91402
*This letter is a personal expression of its author and in no way is to be understood as representing Kaiser Permanente Southern California Permanente Medical Group.
Short-term tocolysls adjunctive to intrapartum term breech management
To the Editors: In the application of a selective protocol for term
breech management, we have been impressed with the number of women who present with breech presentations in advanced active labor. In fact, we have excluded from a trial of labor women who present with ~7 cm dilatation, primarily because of the risks in sending the patient to radiology for x-ray studies.' Recently we began using short-term tocolytic therapy as an adjunct for management for women who present in advanced active labor with breech presentation, as in the following cases:
Case 1. A 19-year-old nulliparous woman presented in active labor. Pelvic examination revealed a breech presentation with the cervix dilated to 9 cm. Ultrasound scanning revealed a normal fetal skull. Terbutaline, 250 µg, was administered subcutaneously for short-term tocolysis. The patient chose cesarean section for delivery. An "expedited" cesarean section instead of a "stat" cesarean section was performed, with delivery of a 3680 gm female infant with Apgar scores of 8 and 9.
Correspondence 233
Case 2. A 24:year-old woman, gravida 2, para I, was admitted in active labor with 6 to 7 cm dilatation with a breech presentation. Terbutaline, 250 µg, was administered subcutaneously. After frank discussion the patient opted for a trial of labor and was sent for x-ray pelvimetry with virtually no contractions. X-ray films revealed an adequate pelvis with a flexed and normal fetal skull. The patient resumed active labor in about I hour and was delivered by assisted breech delivery of a 3150 gm male infant with Apgar scores of 6 and 9.
Case 3. A 37-year-old woman, gravida 5, para 4, was admitted in active labor. Pelvic examination revealed a floating breech presentation with membranes intact. Ultrasound scanning showed ample amniotic fluid volume and a normal-appearing fetus. Fetal monitoring showed a reactive fetal heart rate pattern and frequent uterine contractions. Terbutaline, 250 µg, was given subcutaneously and external cephalic version performed in the cesarean section room under doublesetup conditions. The fetus was converted to a vertex presentation, the membranes were ruptured, internal monitoring was employed, and the patient ultimately had a normal spontaneous delivery of a 3475 gm male infant with Apgar scores of 7 and 8.
A selective trial of labor in managing breech presentation is a reasonable alternative to elective cesarean section when protocol is strictly followed. 1.
2 However, time is required to evaluate the fetal skull for normalcy and extension as well as the maternal bony pelvis x-ray examination.
For those services in which cesarean section is the primary route of delivery, short-term tocolysis will allow for more time in preparing for surgery, assembling the delivery team, and cross-matching blood. It may even allow for the use of regional anesthesia in place of general anesthesia.
Therefore we feel that a role exists for the use of "one-shot" ~-mimetic therapy in (1) proposing a management scheme for any individual patient, (2) evaluating the fetus prior to delivery, and (3) carrying out the intended plan for labor and delivery. In the absence of contraindications for a ~-mimetic drug' we have found terbutaline used subcutaneously to be efficacious and safe.
Martin L. Gimovsky, M.D. Department of Obstetrics and Gynecology White Memorial Medical Center Los Angeles, California 90033
REFERENCES
I. Gimovsky ML, Wallace RL, Schifrin BS, Paul RH. Randomized management of the nonfrank breech presentation at term: a preliminary report. AM J 0BSTET GYNECOL 1983;146:34.
2. Collea JV, Chein C, Quilligan EJ. The randomized management of term frank breech presentation: a study of 208 cases. AM J 0BSTET GYNECOL 1980;137:325.
3. Wallace RL, Caldwell DL, Ansbacher R, Otterson WN. Inhibition of premature labor by terbutaline. Obstet Gynecol 1978;51:387.
Do midforceps deliveries really impair subsequent intelligence quotient scores?
To the Editors: Dr. Friedman and his colleagues (AM J OBSTET Gv
NECOL 1984;150:941) have added to, rather than re-
234 Correspondence
solved, "any remaining conflict" over the use of midforceps deliveries today by misrepresenting the available information on the subject, by reanalyzing material that is more than 25 years old, and by drawing inappropriate inferences from their analysis. All of us recognize that "forceps, like motorcars, kill or maim if not used properly."' The real issue is whether we can do without them, and if not, whether criteria for the safe use of forceps can be established and adhered to in practice.
Friedman's claim that "few (midforceps deliveries) are done at present" is difficult to substantiate, and neither his own book nor the experience at the National Hospital in Dublin, which were cited as references to justify that claim, provides a representative or balanced portrayal of current practice. In fact, over the past 20 years or so the rates of midforceps deliveries appear to have doubled, surprisingly enough,'· 2 probably because of the more frequent use of epidural anesthesia. Indeed, this has been the case even in Dr. Taylor's own institution,' where the idea of doing away with midforceps deliveries of necessity originated, an idea with which, parenthetically, all of us who continue to perform midforceps deliveries would agree.'·' (At The National Hospital in Dublin the epidural rate among primigravid women is under 5%.)
Friedman's next claim, namely, that" ... consistently adverse effects from midforceps procedures have been reported in all controlled investigations thus far published," is even more extraordinary. First, it is untrue. McBride et al., 5 for example, concluded from their study (which included 175 midforceps deliveries, 188 low-forceps deliveries, 101 elective cesarean sections, and 207 spontaneous deliveries) that "Family background variables were the most powerful predictors of intellectual ability in the child. Higher occupational status, higher maternal intelligence, and lower parity related to higher I.Q. Perinatal descriptors and method of delivery did not contribute significantly to intellectual ability." Second, of the three references cited by Friedman as being "controlled investigations"2
· 6
· 7 only
the study by Chiswick and James7 was in fact a controlled study, no matter how one chooses to define that somewhat loose phrase. Far from being ignored, as the authors would have the reader believe, this study has been cited to support the abandonment of the use of midforceps deliveries when there is fetal asphyxia.' In that study, all babies who manifested abnormal neurological behavior after birth but who were not asphyxiated before delivery were normal by 7 days, and the authors attributed the abnormality to transient cerebral edema. Furthermore, Chiswick subsequently examined, both neonatally and at 2 years, 101 babies delivered with use of Kielland's forceps in 1979.8 There were no neonatal deaths, his previous findings on the association between fetal distress and neonatal irritability were confirmed, and none of the babies who manifested abnormal neurological behavior in the neonatal period was handicapped at 2 years. It is also noteworthy
September 15, 1985 Am J Obstet Gynecol
that in the absence of fetal distress none of the features of labor correlated with the development of abnormal neonatal neurological behavior.
Dr. Friedman wants us to accept, without question and in the face of conflicting evidence, that 680 cases culled, not at random, from an original cohort of about 50,000, from which groups of 50 to 70 were selected and matched with an equal number of cases for race, parity, birth weight, and either mode of delivery or labor pattern, can reassure us that the groups being compared are alike in all respects that determine intelligence quotient scores at 7 years except the indexing factor. We should be in no doubt that the indexing factor was solely responsible to the differences in mean intelligence quotient observed. This suggestion is not only absurd but pedagogically irresponsible. Even if we do accept the findings, however, they do not allow the conclusion that delivery by cesarean section would have necessarily improved these children's intelligence quotient scores, for the authors have not studied cesarean sections. Indeed, a retrospective comparison of neonatal outcome after deliveries with use of Kielland's forceps, failed Kielland's forceps deliveries, and cesarean sections performed in the second stage (without prior application of forceps), although obviously not free from the same criticism, provided no indication that this assumption is in fact tenable.9 Furthermore, Dr. Friedman's analysis has shown that dysfunctional labors in themselves have a detrimental effect on intelligence quotient scores as great as anything attributable to midforceps deliveries per se. Therefore, if the authors actually believe in their data and wish to be consistent in the logic they apply to them, then they should have admonished us to abandon trial of labors, since whenever we give oxytocin for an active-phase labor aberration, we are guilty of jeopardizing that child's subsequent mental development, even if we correct the abnormality and secure a spontaneous delivery. Anyone who might be tempted to accept the conclusions of this paper should reflect on the fact that it lends the same degree of support for abandoning trials of labor as it does to abandoning mid forceps deliveries.
Nicholas Kadar, M.A. Department of Obstetrics and Gynecology King's College Hospital Denmark Hill London, SE 5, England
REFERENCES
1. Paintin DB, Vincent F. Forceps delivery-obstetrical outcome. In: Beard RW, Paintin DB, eds. Outcomes of obstetric intervention in Britain. London: Royal College of Obstetricians and Gynaecologists, 1980.
2. Bowes WA, Bowes C. Current role of midforceps operations. Clin Obstet Gynecol 1980;23:549.
3. Paintin DB. Mid-cavity forceps deliveries. Br J Obstet Gynaecol l 982;89:495.
4. Drife JO. Kielland or Caesar? Br Med J l 983;287:309. 5. McBride WG, Black BP, Brown CJ, Dolby RM, Murray AD,
Volume 153 Number 2
Thomas DB. Method of delivery and developmental outcome at five years of age. Med J Aust 1979; 1 :301.
6. O'Driscoll K, Meagher D, MacDonald D, Geoghegan F. Traumatic intracranial haemorrhage in firstborn infants and delivery with obstetric forceps. Br J Obstet Gynaecol 1981;88:577.
7. Chiswick ML, James DK. Kielland's forceps: association with neonatal morbidity and mortality. Br Medj 1979; 1 :7.
8. Chiswick ML. Forceps delivery: neonatal outcome. In: Beard RW, Paintin DB, eds. Outcomes of obstetric intervention in Britain. London: Royal College of Obstetricians and Gynaecologists, 1980.
9. Traub AI, Morrow RJ, Ritchie JWK, Dornan KJ. A continuing use for Kielland's forceps? Br J Obstet Gynaeol l 984;91:894.
Reply To the Editors:
The stridency of Mr. Kadar's letter has enveloped him in the fallacy of ignoratio elenchi by which he attempts to undermine the results of our study by using arguments dealing with issues either not addressed or irrelevant. The only matter on which he is perhaps on more logically acceptable grounds is that pertaining to the limited number of controlling factors invoked for the case-matching process. Although they constitute more than any heretofore used, it is patently clear that they are not all-encompassing. To rail against universally accepted basic statistical design and principles, however, is hardly fitting. As indicated in the paper, the report is merely a small part of a much larger study in which the fetal impact of a very large number of risk factors (2441 in all) is being examined by a series of more sophisticated analytic techniques, including logistic regression modeling. As this mammoth investigation nears completion, it appears the results will be the same. Given the closely held biases expressed in the letter, even that may not be enough to convince.
Emanuel A. Friedman, M.D. Department of Obstetrics and Gynecology Beth Israel Hospital 300 Brookline Avenue Boston, Massachusetts 02215
Menstrual extraction
To the Editors: I want to draw your attention to the incorrect title
given to an article by Borten and Friedman on the use of prostaglandins for performing early abortions (Postconceptual induction of menses with double prostaglandin F2• impact. AM J 0BSTET GYNECOL 1984; 150: 1006). Menstrual flow is not the result of postconception prostaglandin use. The result is the expulsion and death of a human embryo.
Whatever your moral position on abortion (if any), you owe your readers at least a dedication to the proper use of language-because failure results in faulty communication and subjects your readers to influences other than the intrinsic persuasion of scientific truth. It need hardly be pointed out that the abortion halo-
Correspondence 235
caust was in part brought about in our land by linguistic perversions such as "menstrual extraction" and "she has a right over her own body."
Marshall D. Matthews, M.D. 840 Hill Avenue Moses Lake, Washington 98837
Reply To the Editors:
Menstruation is defined as a periodic hemorrhage arising from the endometrium. Infrequent, irregular menstruation (oligomenorrhea) and vaginal bleeding in ovulatory women are also considered menses notwithstanding the fact that, etymologically, the Latin root means monthly. Menstrual induction has for some time been the accepted term for describing a suction aspiration curettage in women with delayed menses because proof of pregnancy was not always needed or forthcoming. Several other similar terms have been invoked to describe this procedure, such as menstrual extraction, menstrual regulation, and menstrual aspiration. At the present time, menstrual extraction or induction is used to describe a pregnancy termination that does not require extensive surgical manipulation (that is, cervical dilatation).
In our study we merely reported our findings with use of prostaglandin F20 instead of suction aspiration. As clearly stated in the title, the medication was given to women known to be pregnant (postconceptional). In the section on material and methods, we specified that a positive pregnancy test was a prerequisite for including subjects. At no time was it our intention to mislead any reader. We are certain we have not done so. Clarity and consistent terminology facilitate communication and understanding. Inflammatory shibboleths (for example, abortion holocaust) do not.
Max Borten, M.D. Emanuel A. Friedman, M.D., Sc.D.
Department of Obstetrics and Gynecology Harvard Medical School Beth Israel Hospital 330 Brookline Avenue Boston, Massachusetts 02215
Placentas of small-for-dates infants from Mexico City, Mexico
To the Editors: I have read with great interest the paper by Davies
et al. (AMJ OBSTET GYNECOL 1984;149:731) in which they report an increased number of villi with fibrinoid necrosis as well as a higher frequency of atherosis in placentas from cases of intrauterine growth-retarded infants with marginal insertion and a normal or thick cord. These infants had the most severe growth retardation and, their mothers experienced a higher frequency of preeclampsia. In this study of small numbers, the authors did not find one case of villitis.
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