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Postpartum Oral Contraception: A Clinical Evaluation
Postpartum Oral Contraception: A Clinical Evaluation FRANK M. RECH, M.D., and RICHARD H. SCHWARZ, M.D.
in pregnancy spacing is the problem of the ability of the patient to follow a reasonable program. 1 Instruction is commonly given at the time of the first postpartum visit or subsequent thereto, but in the case of many multigravidas this may be and often is too late. While it is not the intent of this report to delve into the multiple problems with which the patient may have to cope after hospital discharge, it is our opinion that the approach suggested below is both applicable and acceptable to the patient. Another major concern, especially in the clinic population, is motivation for contraception and interest in postpartum follow-up.l,5 Experience has shown that many patients fail to return for family planning advice, ever though they seem motivated to do so during their hospital stay. When postpartum patients request oral contraception, it has been common practice to await the onset of the first menstrual period before starting administration of the drug. 4 To assure safety, either abstinence or the use of another method is necessitated until that time. It should also be noted that when low-dosage preparations are prescribed caution is recommended early in the first cycle since ovulation may not be uniformly suppressed. 2 Administration of an oral progestagen in the immediate postpartum period seemed a reasonable approach to the problem. Initiating the program before the patient is discharged from the hospital and while pregnancy is uppermost in her thoughts seemed to offer a better approach to the problem of spacing future pregnancies. It has been our finding that there is a significant problem of anxiety regarding conception and coitus without protection from pregnancy during this period. The purpose of this study was to evaluate the use of an oral contraceptive, ethynodiol diacetate 1.0 mg. with mestranol 0.1 mg., in general, and specifically in the immediate postpartum period. INHERENT
From the Department of Obstetrics and Gynecology, Philadelphia General Hospital, Philadelphia, Pa. The ethynodiol acetate 1.0 mg. with mestranol 0.1 mg. (Ovulen) used in this study was supplied by G. D. Searle & Co., Chicago, Ill.
556
VOL.
17, No.4, 1966
POSTPARTUM CONTRACEPTION
557
METHOD Postpartum patients expressing an interest in family planning were interviewed by a physician in an effort to select the most highly motivated individuals. The patients selected were married, evidenced good clinic attendance, and were not breast-feeding their babies. The therapy was initiated on the day after hospital discharge according to the usual plan: 1 tablet each night for 20 days, and therapy beginning again on the fourth day after the onset of vaginal bleeding. Most patients were discharged on the fourth postpartum day and therapy was started on Day 5, but if complications necessitated longer hospitalization, therapy was started on Day 5 in the hospital. Instructions were given by a physician and the patients were asked to chart bleeding and untoward symptoms. They were given sufficient medication for 1 cycle and were interviewed by the physician each time they returned for medication. RESULTS
A total of 77 patients completed first cycles and reported for first evaluations. An additional 8 patients registered in the study but did not report back at the end of the first cycle. An additional 25 patients dropped out of the study at the second through the tenth cycle. There have been a total of 706 patient-cycles to date with no known pregnancies. The longest follow-up is 20 cycles, the shortest, 1. Spotting and breakthrough bleeding occurred in 47 of the 706 cycles. Seventeen of these occurrences were in the first cycle and 10 of the later instances occurred when medication was skipped. Nausea occurred in 17 cycles, dizziness in 12, and headaches in 17. Interestingly, dysmenorrhea was reported in 31 cycles. Of 46 multigravidas who could recall their lochia with previous pregnancies, 24 felt that their lochia was less during the first cycle of treatment, after this pregnancy; 17 reported the lochia as being the same as before, and 5 thought that it was heavier. No breast engorgement or pain was reported and breast involution was complete in all cases. No patient had received medication for the suppression of lactation, the standard management consisting of the application of a tight binder. Thus to suppress lactation, even earlier administration of ethynodiol diacetate 1.0 mg. with mestranol 0.1 mg. might be indicated. 2 • 3 Twenty-five patients reported coitus one or more times during the first cycle. The average length of the first cycle was 26 days after the initiation of therapy-i.e., 31 days postpartum. Only 2 patients did not bleed after the first course of medication. For these patients the drug was given again 7
558
RECH & SCHWARZ
FERTILITY & STERILITY
days later and they subsequently bled with the second cycle. Uterine involution was reported to be satisfactory in all instances at the time of the postpartum pelvic evaluation. COMMENT
Although this evaluation was a purely clinical one, not accompanied by basal temperature records, endometrial biopsies, or hormone assays, it suggests that such studies might indeed be worthwhile. It also suggests that early postpartum initiation of oral contraception could relieve problems inherent in awaiting the resumption of menses. SUMMARY
In a clinical evaluation of the early postpartum use of an oral contraceptive, ethynodiol acetate 1.0 mg. with mestranol 0.1 mg., 77 patients completed the first cycle and a total of 706 patient cycles was evaluated. Side effects were minimal. Breakthrough bleeding and spotting occurred mainly in the first postpartum cycle. . Department of Obstetrics and Gynecology Philadelphia General Hospital Philadelphia, Pa. 19104
REFERENCES 1. DuBOIS, C. A. "Sociocultural Aspects of Population Growth." In Human Fertility and Population Problems. Greep, R 0., Ed. Schenkman, Cambridge, 1963, pp. 251-274. 2. GARCIA, C. R, and PINCUS, G. Clinical consideration of oral hormonal control of human fertility. Glin Obstet Gynec 7:844, 1964. 3. GARCIA, C. R, and PINCUS, G. Ovulation inhibition by progestin-estrogen combination. Int J Fertil 9:95, 1964. 4. GOLD, J. J., SCOMMEGNA, A., and BORUSHIK, S. The clinical use of ovulation suppressants. Med Glin N Amer 47: 131, 1963. 5. OSBON, F. The world crisis in population growth. Glin Obstet Gyne,c 7:753, 1964.
in pregnancy spacing is the problem of the ability of the patient to follow a reasonable program. 1 Instruction is commonly given at the time of the first postpartum visit or subsequent thereto, but in the case of many multigravidas this may be and often is too late. While it is not the intent of this report to delve into the multiple problems with which the patient may have to cope after hospital discharge, it is our opinion that the approach suggested below is both applicable and acceptable to the patient. Another major concern, especially in the clinic population, is motivation for contraception and interest in postpartum follow-up.l,5 Experience has shown that many patients fail to return for family planning advice, ever though they seem motivated to do so during their hospital stay. When postpartum patients request oral contraception, it has been common practice to await the onset of the first menstrual period before starting administration of the drug. 4 To assure safety, either abstinence or the use of another method is necessitated until that time. It should also be noted that when low-dosage preparations are prescribed caution is recommended early in the first cycle since ovulation may not be uniformly suppressed. 2 Administration of an oral progestagen in the immediate postpartum period seemed a reasonable approach to the problem. Initiating the program before the patient is discharged from the hospital and while pregnancy is uppermost in her thoughts seemed to offer a better approach to the problem of spacing future pregnancies. It has been our finding that there is a significant problem of anxiety regarding conception and coitus without protection from pregnancy during this period. The purpose of this study was to evaluate the use of an oral contraceptive, ethynodiol diacetate 1.0 mg. with mestranol 0.1 mg., in general, and specifically in the immediate postpartum period. INHERENT
From the Department of Obstetrics and Gynecology, Philadelphia General Hospital, Philadelphia, Pa. The ethynodiol acetate 1.0 mg. with mestranol 0.1 mg. (Ovulen) used in this study was supplied by G. D. Searle & Co., Chicago, Ill.
556
VOL.
17, No.4, 1966
POSTPARTUM CONTRACEPTION
557
METHOD Postpartum patients expressing an interest in family planning were interviewed by a physician in an effort to select the most highly motivated individuals. The patients selected were married, evidenced good clinic attendance, and were not breast-feeding their babies. The therapy was initiated on the day after hospital discharge according to the usual plan: 1 tablet each night for 20 days, and therapy beginning again on the fourth day after the onset of vaginal bleeding. Most patients were discharged on the fourth postpartum day and therapy was started on Day 5, but if complications necessitated longer hospitalization, therapy was started on Day 5 in the hospital. Instructions were given by a physician and the patients were asked to chart bleeding and untoward symptoms. They were given sufficient medication for 1 cycle and were interviewed by the physician each time they returned for medication. RESULTS
A total of 77 patients completed first cycles and reported for first evaluations. An additional 8 patients registered in the study but did not report back at the end of the first cycle. An additional 25 patients dropped out of the study at the second through the tenth cycle. There have been a total of 706 patient-cycles to date with no known pregnancies. The longest follow-up is 20 cycles, the shortest, 1. Spotting and breakthrough bleeding occurred in 47 of the 706 cycles. Seventeen of these occurrences were in the first cycle and 10 of the later instances occurred when medication was skipped. Nausea occurred in 17 cycles, dizziness in 12, and headaches in 17. Interestingly, dysmenorrhea was reported in 31 cycles. Of 46 multigravidas who could recall their lochia with previous pregnancies, 24 felt that their lochia was less during the first cycle of treatment, after this pregnancy; 17 reported the lochia as being the same as before, and 5 thought that it was heavier. No breast engorgement or pain was reported and breast involution was complete in all cases. No patient had received medication for the suppression of lactation, the standard management consisting of the application of a tight binder. Thus to suppress lactation, even earlier administration of ethynodiol diacetate 1.0 mg. with mestranol 0.1 mg. might be indicated. 2 • 3 Twenty-five patients reported coitus one or more times during the first cycle. The average length of the first cycle was 26 days after the initiation of therapy-i.e., 31 days postpartum. Only 2 patients did not bleed after the first course of medication. For these patients the drug was given again 7
558
RECH & SCHWARZ
FERTILITY & STERILITY
days later and they subsequently bled with the second cycle. Uterine involution was reported to be satisfactory in all instances at the time of the postpartum pelvic evaluation. COMMENT
Although this evaluation was a purely clinical one, not accompanied by basal temperature records, endometrial biopsies, or hormone assays, it suggests that such studies might indeed be worthwhile. It also suggests that early postpartum initiation of oral contraception could relieve problems inherent in awaiting the resumption of menses. SUMMARY
In a clinical evaluation of the early postpartum use of an oral contraceptive, ethynodiol acetate 1.0 mg. with mestranol 0.1 mg., 77 patients completed the first cycle and a total of 706 patient cycles was evaluated. Side effects were minimal. Breakthrough bleeding and spotting occurred mainly in the first postpartum cycle. . Department of Obstetrics and Gynecology Philadelphia General Hospital Philadelphia, Pa. 19104
REFERENCES 1. DuBOIS, C. A. "Sociocultural Aspects of Population Growth." In Human Fertility and Population Problems. Greep, R 0., Ed. Schenkman, Cambridge, 1963, pp. 251-274. 2. GARCIA, C. R, and PINCUS, G. Clinical consideration of oral hormonal control of human fertility. Glin Obstet Gynec 7:844, 1964. 3. GARCIA, C. R, and PINCUS, G. Ovulation inhibition by progestin-estrogen combination. Int J Fertil 9:95, 1964. 4. GOLD, J. J., SCOMMEGNA, A., and BORUSHIK, S. The clinical use of ovulation suppressants. Med Glin N Amer 47: 131, 1963. 5. OSBON, F. The world crisis in population growth. Glin Obstet Gyne,c 7:753, 1964.