The drospirenone only pill as a contraceptive option for breast feeding women. Safety aspects on new-born and users’ acceptability

Abstract

Abstract Background Progestin-only pills (POPs) and progestogen contraceptives have been used for contraception in breastfeeding women for years. When used by lactating women, POPs do not interfere with a woman's ability to breastfeed. Evidence from observational and randomized studies generally supports the notion that POPs do not have adverse effects on infant growth, health, or development during the first year postpartum. Methods This was a multicentre observational study conducted with a single visit and retrospective data review. The study involved 100 women who used a drospirenone-only pill (DRSP) for contraception during breastfeeding. The study aimed to analyse the impact on new-born development, assess the bleeding profile, and evaluate user satisfaction. Results The analysis of the new-borns showed that their growth parameters including length and weight were within the expected range of standard development. The mean birth weight was 3368 g (median 3360 g), with the lowest recorded weight being 860 g and the highest 5040 g. The median length of the new-borns was 55 cm, ranging from 35 cm to 65 cm. All new-borns demonstrated appropriate growth without any signs of retardation. No adverse effects were observed in the new-borns. Regarding the satisfaction with the bleeding profile, the median satisfaction rating was 89.5, while the mean value was 82.8. Notably, women aged 35 years or older reported significantly higher satisfaction compared to younger women (≥35 years: mean=88.4, SD=16.5; <35 years: mean=80.3, SD=20.2) (p = 0.02). More than half of all patients (N=61; 61.0%; 95% CI: 50.7 - 70.4%) expressed their willingness to continue using DRSP after breastfeeding, including 24 patients who had previously used combined oral contraceptives before their pregnancy. Conclusion The DRSP contraceptive pill demonstrated high safety for new-borns, with no clinical impact observed on their growth. Additionally, users expressed high satisfaction with the bleeding profile of the pill. Out of the users, sixty-one individuals decided to continue using this contraceptive method after breastfeeding, highlighting the effectiveness of the drospirenone-only pill as a valid option for contraception during and after breastfeeding. Clinical trial registration number: DRKS00028438