for the use only of registered medical practitioners, or a hospital or a Laboratory.
A Controlled Trial of AYAPON in Copper T. (l.U.C.D.)
Post insertional Bleeding after MTP in Family Planning
Dr. Mrs. Gouri Ral Chowdhuri
Senior Medical Officer, Family welfare Dept. Safdarjang Hospital New Delhi-16.
Introduction
With the legalisation of abortion as a health measure for Family Planning, Medical Termination of Pregnancy (MTP) is being done on a mass scale as a part of routine family welfare work. The women undergoing M.T.P. are advised contraceptive measures to prevent repeated MTP. Copper T (l.U.C.D.) is advocated as the most reliable and convenient contraceptive measure. It is inserted immediately after MTP. Howerver, haemorrhage is a common complication in cases of MTP/l.U.C.D. insertion. The cause of this bleeding is not clear, but is thought to be functional in origin, as trauma or any endometrial reaction is not found. ·
Materials And Methods
This study was carried out in 100 cases of early pregnancy who had MTP by suction evacuation method and immediately Copper T, the l.U.C.D. which was preferred, was inserted. About 15.20% of these cases developed bleeding as a complication, immediately, or during menstrual Period or during intermenstrual period. Those cases with systemic or any other disease were excluded from the study. Cases with a history suggestive of dysfunctional uterine bleeding, cases of incomplete medical termination of pregnancy and cases who developed pelvic inflammation, were excluded from this study. Also those cases wherein expulsion of l.U.C.D. occurred were also excluded from the study, though expulsion with Copper T was much less. Only those 100 case where uterine bleeding was known to be entirely due to insertion of l.U.C.D. after MTP were taken up for this study. Out of these cases 50 were taken as the Ayapon Group (Trial Group) and 50 cases were taken as the Control Group. All the 100 cases were given iron and multivitamins as supportive Therapy. In addition the Trial Group received Ayapon the Ayurvedic drug. There were no drop-outs in the follow-up of cases.
Selection of Ayapon
Ayapon an Ayurvedic drug was selected for this study. It consists of Ayapana (Eupatorium ayapana), Nagkesar (Mesua ferra), Ashoka (Saraca lndica), Godanti Bhasam (Gypsum), kamboji (Breynia patens) and Jeevanti (Leptadenia reticulate). The main ingredient Ayapana was a B.P. drug till some years ago.
Its essential constituents are Ayapan and Ayapanin both of which possess haemostatic property. The chief properties of the drug “Ayapon” are haemostatic, astringent and uterine sedative. It also provides calcium in an easily assimilable form due to Godanti Bhasma
It was selected for trial since it is a non-hormonal preparation and hence side-effects are expected to be minimum and there is less chance of any complication due to prolonged therapy.
Dosage of Ayapon: (A) In cases of im mediate bleeding and intermenstrual bleeding and spotting, Ayapon was given 2 tabs, three times a day for one week, followed by 2 tabs, twice a day for a week and in the third week Ayapon was given 1 tab three times a day. This was repeated for three menstrual cycles.
TABLE NO. I: AGE GROUPS
| Age Group | Ayapon Group | Control Group | Total | % |
| 16-20 years: | 2 | 2 | 4 | 4% |
| 21-25 years: | 16 | 15 | 31 | 31% |
| 26-30 years: | 22 | 21 | 43 | 43% |
| 31-35 years: | 5 | 6 | 11 | 11% |
| 36-40 years: | 5 | 6 | 11 | 11% |
| Total: | 50 | 50 | 100 | 100% |
TABLE No. II: PARITY
| Para | Ayapon Group | Control Group | Total | % |
| Para I | 10 | 9 | 19 | 19% |
| Para II | 19 | 16 | 35 | 35% |
| Para Ill | 12 | 15 | 27 | 27% |
| Para IV | 6 | 7 | 13 | 13% |
| Para V | 3 | 3 | 6 | 6% |
| Total: | 50 | 50 | 100 | 100% |
TABLE No. Ill: BLEEDING COMPLAINTS
| Bleeding | Ayapon Group | Control Group | Total | % |
| Immediate Bleeding episodes | 28 | 29 | 57 | 57% |
| Menorrhagia | 8 | 8 | 16 | 16% |
| Metrorrhagia/spotting | 14 | 13 | 27 | 27% |
| Total: | 50 | 50 | 100 | 100% |
(B) In cases of excessive bleeding druing menstruation (menorrhagia), Ayapon was given 2 tabs three times a day for one week, followed by 2tab two times a day for another week. Also Ayapon was given 2 tabs three times a day, commencing from 5 days before the expected date of menstruation. It was con- tinued for 1 week from the day of menstruation as already said. This was repeated for three menstrual cycles.Besides this, these cases received the supportive Iron and multivitamins. 50 cases of the Control Group were not given Ayapon, but received only the supportive therapy of Iron and multivitamins.
Age Groups
The maximum number of 43 cases (43%) was In the Age Group of 26-30 years. The age groups of 21-30 years formed 74% of the total (Table No. 1)
Parity
The maximum number of 35 cases (35%) belonged to Para II. Primipara formed only 19% of the Total. (Table No. II)
Bleeding
57 cases (57%) came with moderate bleeding as an immediate complication of post MTP, Copper Insertion. 16 cases (16%) came with menorrhagia and 27 cases (27%) presented with lntermenstrual bleeding/spotting. The details are given in Table No. Ill.
Classification of Results
Good: Where bleeding was controlled within 5-10 days of immediate bleeding and there was no recurrence. In cases of menorrhagia and metrorrhagia, when bleeding was controlled in the following two menstrual cycles.
Fair: When bleeding was controlled within 10-15 days of immediate bleeding and there was no recurrence. In cases· of menorrhagia and metrorrhagia, when bleeding was controlled led in the following three menstrual cycles.
Poor: When bleeding was not controlled even after 15 days in case of immediate bleeding. In cases of menorrhagia and metrorrhagia when bleeding was not controlled, even after three menstrual cycles.
Results
Good results were seen in 60% of the Ayapon Group and 30% of the Control Group. Fair Results were seen in 30% of Ayapon Group. and 30% of the Control Group. Poor results were seen in 10% of the Ayapon Group and 40% of the Control Group. On the whole the results were satisfactory in 90% of the Ayapon Group and 60% of the Control Group. (Table No. IV)
Statistical Study
For the purpose of statistical study, cases of Good results are taken in one group and cases of Fair + Poor results are taken together in another group. Good results are seen in 30 cases of Ayapon group and 15 cases of Control Group, that is a total of 45 cases. 20 cases of the Ayapon Group and 35 cases of the Control Group, a total of 55 cases, did not show Good results.
We start with the hypothesis that the effects of the Ayapon Group are no different from that of the Control Group, in controlling bleeding after copper T insertion following MTP. This hypothesis is then put to test to see whether this is valid or is to be rejected. Using chi-square test for 2 x 2 contingency tables, it is found that Ayapon has a definite action in controlling bleed ing in Copper T -1.U.C.D. Insertion cases after
MTP and this is found to be statistically significant at P < 0.01 level (Table No. V)
TABLE NO. IV: RESULTS
| Result | Ayapon Group | % | Control Group | % | Total | % |
| Good | 30 | 60% | 15 | 30% | 45 | 45% |
| Fair | 15 | 30% | 15 | 30% | 30 | 30% |
| Poor | 5 | 10% | 20 | 40% | 25 | 25% |
| Total | 50 | 100% | 50 | 100% | 100 | 100% |
TABLE NO. V. RESULTS: STATISTICAL STUDY (Chi Square test)
| Group | Good | Fair + Poor | Total |
| Ayapon Group | 30 | 20 | 50 |
| Control Group | 15 | 35 | 50 |
| Total: P 0.01 | 45 | 55 | 100 |
Discussion
Among the Ayapon Group, Good results were obtained in 60% of the cases and 30% of the cases had fair results, thus showing 90% of Satisfactory response. In Control Group,the results were approximately divided equally among all grades. From this it is observed that Ayapon has beneficial action in controlling post-MTP Copper T insertional bleeding.Out of failed cases, 2 cases required removal of Cop per T-1 U C.D., out of which one was from the Ayapon Group and the other was from the con trol Group.
No side effects were observed following the use of Ayapon , neither was there any withdrawal bleeding. This shows that Ayapon is a safe and useful non-hormonal drug that can be used routinely in cases of bleeding due to insertion of I.U.C.D., and particularly when l.U.C.D. insertion follows MTP as a family planning measure.
Summary
The use of Ayapon was taken up for study at the Family Planning Dept. of the Safdarjang Hospital, New Delhi. The study was on those cases which showed bleeding episode after inserting copper T -I.U.C.D. following MTP. and where the patients had agreed to have copper T- l.U.C.D. as a Family Planning measure. 50 patients formed the Ayapon Group and 50 patients formed the Control Group. Satisfactory response in the control of bleeding either immediate or as menorrhagia and metrorrhagia was seen in 90% of the Ayapon Group and 60% of the Control Group. All the 100 cases had received supportive measure in the form of iron and multivitamins.
The results of Ayapon treatment are statistically significant at P <0.01. Ayapon seems to be an effective, and safe non-hormonal drug that can be routinely used in l.U.C.D. Insertions in Family Planning, and particularly after MTP to control or minimise bleeding or as a prophylactic measure.
Acknowledgement
I am thankful to Dr. (Miss) V. N. Khare, Head of the Dept. of Obstetrics & Gynaecology, Safdarjang Hospital, New Delhi, for guidance and to the Medical Superintendent for permission to conduct this trial. I am also thankful to Alarsin Pharmaceuticals, for supply of Ayapon tablets.
References
- Kamat, S. & Anjaneyulu, R. (1977) Use of Ayapon in Uterine Bleeding after Medical Termination of Pregnancy and insertion of IUCD (Cut – 200) xx All India Obst. & Gynec., Cont., Gauhati, 3-6 Jan. 77 & The Indianpract. Vol. 30, No. 9, Sept. 77 pp. 383-391
- Kodkany Kamal, (1968): Use of Ayapon in Intra-uterine Bleeding after l.U.C.D.: The Indian Pract. 21 :12, Dec. 1968
- Lalitha Ananthasubramaniam , Kasturi, & Jaya Rajendran (1975): Ayapon in Post-ln sertional Bleeding: Mediscope, Vol. XVII, No. IX, 17: 9, December 1975.
- Ramani Sivaraman, (1976): Treatment of Uterine Bleeding after MTP & IUCD with Ayapon and its long term effect – First Asian Congress of Induced Abortion & Voluntary Sterilisation, Bombay, 4-9 March
- Ursekar, D. (1973): Ayapon to control bleeding after IUCD: Mah. Med. jr. Vol. XX, No. 3, June, 1973:Reprinted from The Medicine & Surgery Vol. XX, No. 2, February, 1980