WORK IN PROGRESS MENSTRUAL INDUCTION WITH PGFZcrAND PGE2 P. Mocsary and A.I.

Csapo

The "Prostaglandin Impact" (PGI) is a massive intrauterine dose of PG which, by provoking a regulatory imbalance, converts the refractory pregnant uterus into a reactive organ. This rew conversion releases the endogenous mechanism of menstruation or abortion. Depending on the degree of regulatory imbalance provoked by PGI, either no additional PG treatment is needed or it has to be given to sust in ffective uterine stimulation and to promote further conversion ?I,& "Menstrual Induction" (MI) is a non-surgical procedure for the termination of early pre n ncy with the clinical symptoms of menstruation rather than abortion ?27. It is usually performed at around 4 weeks after conception, when the size of the conceptus is initial studies P successfully provoked MI in 22 (SYlld sZ:~$eZy in 65 volunteers Fi ). These re ults were confirm d and complemented by two independent trials in 14 (5s and 36 gravidas P6) espectively. The , when a "PGbest clinical outcome was obtained in 20 volunteers 17‘f Pellet" (a mini-suppositorium) was inserted in utero (with a mini-IUDapplicator), containing only 2.5 mg PGF2cr. These 157 trials in sedated volunteers had the comnon features of over 90% efficiency (in spite of the single PGI used), transient and medically acceptable side effects and infrequent complications. ite of this promising clinical outcome, judgment has in ( 1'3about the clinical merits of MI and the comparative beenHowevery postponed aspects of MI and "Menstrual Extraction" (ME). For, obviously a total of only 157 cases of MI could not provide solid ground for a clinical comparison of MI and ME. However, further research has been recommended, since the consequences of rapid surgical dilatation on the structural integrity of the cervix and on prematurity rates have been recognized(l). This c u ious eva u tion of MI should continue, since two recent trials, in 20 ?8! and 14 197 gravidas respectively, only ach'eve a 70% success 8,9 cannot be rate and encountered 44% infections. These results 19 readily explained since in a third study of 35 patients conducted with the same protocol in the U.S., the success rate was 89% and the infection rate only 14% (W.S.M. Arrata, personal communication). A possible explanation might be found in the conduct of the procedure (in spite of the use of the same protocol) and the medical conditions of the outpatients during the PGI-provoked prolonged menstruation. For, the only From the departments of Obstetrics and Gynecology, Debrecen University School of Medicine, Debrecen, Hungary and Washington University School of Medicine, St. Louis, Missouri. This study was supported by the Agency For International Development AID/csd 3160.

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identifiable ifference between the patients of the successful (2-6) and unsuccessful i' 738) trials was that among the former 9% while among the latter 88% were Spanish American or Blacks, who might have had unrecognized pelvic desease, and were more susceptible to infection. The Australian experience revealed (IO) a close correlation between untreated cervicitis and high infection rate following PG-induced abortions. The present study in 542 volunteers was focused upon the collection of clinical data regarding efficacy, side effects and complications of MI. All patients had committee approval for legal abortion, during the 2nd week after their missed menstrual period. They volunteered to participate in the study because of their preference for pharmacologic 1 rather than surgical pregnancy termination. As in previous studies7334) all patients had positive pregnancy tests and consented to stay at the outpatient clinic for at least 4 hours after PGI. They also agreed to note carefully their symptoms at home, return to the clinic 14 days after PGI for pregnancy test and report the character of their first spontaneous menstrual period one month later. Gravidas with colpitis or cervicitis were cured before undergoing Vaginal preparation before PGI was rigerous. As described earlier rtr the patients were sedated and PGI was delivered high, against the The leakage of PG (back to the vagina) was prevented by slow fun&s. injection and by raising the pelvis. Vital signs and side effects were repeatedly determined during the 4 hours long observation period. The patients were instructed to note and report all complications which occurred until the end of their spontaneous menstrual period. TABLE I SUCCESS RATE OF MENSTRUAL INDUCTION IN 542 PATIENTS WITH PROSTAGLANDINS 4 WEEKS AFTER CONCEPTION Success Rate

1st Menses After PGI Days

No..of Cases

Age Years

Menses Delay Days

PGF2a 5 mg

428

23.6~4.2

13.220.6

95.3

33.5k2.2

PGE2 1.5 mg

114

22.4i2.0

13.1kO.8

93.8

33.8k1.8

Form of Treatment

Values are Means f S.E., except in column 1 and 4. The clinical outcome of the 542 MI with 5 mg PGF2a (428 cases) and 1.5 mg PGE2 (114 cases) is illustrated by Table I. It is apparent that the results obtained in these two comparable groups of patients are identical. On the average, 95% of the gravidas had complete evacuation of the uterus with the clinical symptoms of delayed menstruation rather than abortion in %lO days and experienced spontaneous menstruation in 34 days after having received a single dose of PG.

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TABLE II SIDE EFFECTS AND COMPLICATIONSDURING MENSTRUALINDUCTIONWITH PGF2a AND PGE2

Number of Cases Vomitus Diarrhea BP Change Transient Pyrexia Blood Loss >500 ml Fever 738C Endometritis Adnexitis Curettage

5 mg PGF2a,%

1.5 mg PGE2,%

428

114

15.1 z 2:1

48:: 1::;

:*: 719

:*47 817

1.4 4.7

:::

Table II describes the side effects and complications. Vomiting occurred more frequently in the PGF2a group, while diarrhea, blood pressure change and transient pyrexia in the PGE2 group. Otherwise, the rate of side effects and complications were comparable. All.side effects were transient and the cases of (~8%) endometritis and (*1.5%) adnexitis well responded to therapy. These results, when amplified by further studies and complemented by independent investigations, would allow meaningful comparison between the clinical merits of MI and ME. It is, of course, possible that improved delivery systems for PGI and the development of new analogues will increase success rates still further and reduce the incidence of side effects and complications. Further studies are, therefore, desirable. REFERENCES

:: 3. 4. :: 7. 8. 9.

Csapo, A.I.: Prostaglandins 3: 245, 1974. Population Report, Series G, No. 4, March, 1974. Csapo, A.I.: Csapo, A.I., Mocsary, P., Nagy, T. & Kaihola, H.L.: Prostaglandins 3: 125, 1973. Eocsary, P. & Csapo, A.I.: Lancet 2: 683, 1973. Karim, S.M.M.: Lancet 2: 794, 1973. Ylikorkala, O., Jouppila, P., Ylostalo, P., Jarvinen, P.A.: Prostaglandins 7: 57, 1974. Csapo, A.I. & Mocsary, P.: Lancet 2: 789, 1974. Lichtman, A.S., Brenner, P. & Mishelr, R.: Contraception 2: 403, 1974. Jones, J.R., Gentile, G.P., Kemmann, E.K., Soriero, A.A.: Prosta-

glandins 9: 881, 1975. 10. Waldron, KrW. & Walters, W.A.W.:

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Menstrual induction with PGF2 alpha and PGE2.

The "prostaglandin impact" (PGI), a massive intrauterine dose of PG, converts the refractory pregnant uterus into a reactive organ by provoking a regu...
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