Efficacy and Safety of Ultra Low Dose Oral Contraceptive Pills in Rural Indian Women - A Prospective, Open Label Study

BACKGROUND Combined oral contraceptive pills are the most effective temporary contraception methods and are used by approximately 60 - 80 million eligible women throughout the world. It is the oestrogen component of the combined oral contraceptive (COC) which is responsible for the undesirable and serious side effects such as deep vein thrombosis (DVT) and pulmonary embolism (PE). So, there has been a constant effort to reduce the amount of ethinyl estradiol (EE) while maintaining its contraceptive efficacy. This study was aimed at studying the safety and efficacy of ultralow dose combined oral contraceptive (containing 15 mcg EE + 60 mcg gestodene) in rural Indian women. METHODS The study was done at Rama Medical College, Mandhana, Kanpur, among 70 patients who fulfilled the inclusion criteria. The patients were given ULDOCP and followed up for 6 months. The patients followed the regime of one tablet of ULDOCP daily from day 1 to day 24 of the menstrual cycle with 4 days pill free period before starting the next pack. RESULTS Seventy patients completed the study till 3 months and fifty patients completed the study till 6 months. Break through bleeding (BTB) was the only prominent side effect which was reduced in subsequent cycles and our patients tolerated this well. No pregnancy resulted. The ULDCOP was very well accepted by those women who were counselled about possible side effects and their harmless nature before starting the study. It was found that the users were satisfied with the use of ULDOCP. All side effects were significantly lower after 2 months of use and there were no serious side effects. CONCLUSIONS The 24 / 4 ULDOCP regimen seems to be a safe and effective contraceptive method for use in rural population after properly counselling them. The reduced pill free interval of 4 days offered additional advantages. KEYWORDS Ultra-Low Dose Oral Contraceptive Pills (ULDOCP), Ethinyl Estradiol (EE), Safe Contraception, Gestodene, BTB (Break Through Bleeding)

Randomized Controlled Trial of Tranexamic Acid’s Effect on Bleeding Length: A Study on DMPA Users with Abnormal Uterine Bleeding Who Receive Low-Dose Oral Contraceptive Pill

ABSTRACTBackground: Contraceptive injection is the most common contraception used in Indonesia. Among the contraceptive injections, depomedroxy progesterone acetate (DMPA) is the most effective method with pregnancy rate of 0,3 pregnancy in 100 women annually. Abnormal uterine bleeding (AUB) is a common side effect occurred in DMPA users which leads to the discontinuation of contraception.Objective: To explore the effect of tranexamic acid on bleeding length for DMPA users with AUB who receive low dose Oral Contraceptive Pills (OCP).Methods: We performed double blind randomized control trial between two groups to investigate the effect of tranexamic in managing AUB in DMPA users who receive low dose OCP. This study was performed in Dr. Kariadi Hospital Semarang, Indonesia. Forty-four subjects were divided into two groups, equally. Group 1 received 250 mg tranexamic acid four times a day for 5 days and OCP once a day for 28 days, while Group 2 received placebo four times a day for 5 days and OCP once a day for 28 days. Both groups were evaluated for bleeding length during treatment and were analyzed using Mann Whitney for post treatment with tranexamic acid.Results: The mean bleeding length was 5.2±3.62 days and 9.2±6.16 days in group 1 and 2 respectively. These bleeding lengths were significantly different between both groups (p=0.018). The precentage of subjects in whom bleeding was stopped during the first week after initial treatment was significantly higher in group 1 than group 2 (77,3 % vs 45,5 %, p<0,030).Conclusion: Tranexamic acid significantly reduced the bleeding length in DMPA users who use OCP.

Duration of Oral Contraceptives Use and Risk of Development of Dyslipidemia among Women in Dhaka City

Background: Duration of oral contraceptive use is an important issue for the development of dyslipidemia among women.Objective: The purpose of the present study was to see the duration of use of OCP and the development of dyslipidemia among the women.Methodology: This case control study was carried out in the Department of Obstetrics & Gynaecology and Family Planning Department in collaboration with the Biochemistry Department at Sir Salimullah Medical College & Mitford Hospital, Dhaka from June 2009 to May 2010 for a period of one (1) year. Women using low-dose OC pill for more than one year were considered as cases group while women not using low-dose oral contraceptive pill were taken as control group of the study. Lipid profiles were performed in the laboratory in the fasting state from blood.Result: A total of 80 subjects were recruited for this study of which 40 women in case group and the rest 40 women were in control group. Duration of contraceptive use and serum lipids profiles were recorded. Level of serum total cholesterol, serum triglyceride, and serum LDL were significantly higher among the contraceptive users of > 5 years duration than those among 5 or < 5 years duration (p < 0.001). However, serum HDL level was low among both users and non-users (p=0.556). The risk of developing dyslipidaemia in women using low-dose oral contraceptive was more than 3-fold higher than that in non-users.Conclusion: In conclusion the greater the duration of oral contraceptive use the higher is the chance of dyslipidaemia.Journal of Science Foundation 2016;14(2):40-43

Ultra-low-dose oral contraceptive pill: a new approach to a conventional requirement

Combined oral contraceptives (COCs) offer a convenient, safe, effective, and reversible method of contraception. However, their use is limited by side effects. Several strategies have been suggested to make COC use more acceptable among women. Reduction in the dose of estrogen is a commonly accepted approach to reduce the side effects of COC. Use of newer generation of progestins, such as gestodene, reduces the androgenic side effects generally associated with progestogens. Furthermore, reduction in hormone-free interval, as a 24/4 regimen, can reduce the risk of escape ovulation (hence preventing contraceptive failure) and breakthrough bleeding. It also reduces hormonal fluctuations, thereby reducing the withdrawal symptoms. A COC with gestodene 60 µg and ethinylestradiol (EE) 15 µg offers the lowest hormonal dose in 24/4 treatment regimen. This regimen has been shown to offer good contraceptive efficacy and cycle control. With the progress of treatment cycles, the incidence of breakthrough bleeding reduces. Gestodene/EE low dose 24/4 regimen was associated with lower incidence of estrogen-related adverse events, such as headache, breast tenderness, and nausea. Furthermore, COCs containing low dose of estrogen have not been associated with any adverse effect on haemostasis in healthy women. Ultra-low-dose COCs can be considered in women who are at risk of developing estrogen-related side effects.