Comparative study of the effects of a progestogen-only pill containing desogestrel and an intrauterine contraceptive device in lactating women

Ragnheidur I Bjarnadóttir , Helga Gottfredsdóttir , Kristı́n Sigurdardóttir, Reynir T Geirsson , Thom O.M Dieben
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Abstract

Objective To evaluate the effects of desogestrel 75μg/day, as a progestogen-only pill compared with a copper-bearing intrauterine contraceptive device (IUCD) on lactation and to study the safety of both treatments in mothers and children. Transfer of etonogestrel to breast milk was studied in a subgroup of desogestrel users. The children were to be followed up until 2.5 years of age.

Design An open, non-randomised, group-comparative study in lactating women.

Setting University Hospital, Reykjavik, Iceland.

Participants A total of 83 lactating women; 42 received desogestrel and 41 had an IUCD inserted for seven consecutive treatment cycles of 28 days.

Methods Evaluation visits were planned at baseline and at the end of treatment cycles 1, 4 and 7. The amount of breast milk was determined by weighing the infants before and after feeding, at baseline and after treatment cycles 1 and 4. Milk samples were obtained at the same time for constituent measurements. Safety was studied by structured medical examinations and by recording adverse experiences in mothers and children.

Results There were no significant differences between the desogestrel and IUCD groups in composition and quantity of breast milk nor in growth and development of the children followed up to the age of 2.5 years. In the desogestrel group a slightly higher incidence of mild adverse experiences of a hormonal nature was reported among both mothers and infants. Of the children 82% were followed until 1.5 years of age and 50% until 2.5 years.

Conclusion The use of desogestrel 75μg/day did not change the amount and composition of breast milk nor did it affect growth and development of the breastfed children. It appears to be a safe and effective contraceptive method for lactating women

含去索孕酮的孕激素单药与宫内避孕器在哺乳期妇女中的作用比较研究
目的比较孕激素单药去索孕酮75μg/d与含铜宫内节育器(IUCD)对哺乳期的影响,探讨两种药物对母婴的安全性。在替吉奥孕酮使用者亚组中研究了替吉奥孕酮对母乳的转移。研究人员将对这些儿童进行随访,直到他们长到2.5岁。设计:对哺乳期妇女进行开放、非随机、群体比较研究。Setting大学医院,冰岛雷克雅未克。参与者共83名哺乳期妇女;42例使用地索孕酮,41例使用宫内节育器,连续7个疗程,28天。方法在基线和治疗周期1、4和7结束时进行评估访问。母乳量是通过在喂养前后、基线时以及治疗周期1和4后对婴儿进行称重来确定的。同时获得牛奶样品进行成分测量。通过结构化的医学检查和记录母亲和儿童的不良经历来研究安全性。结果去地孕酮组与宫内节育器组在母乳成分、母乳量及随访至2.5岁儿童生长发育方面均无显著差异。在去索孕酮组中,在母亲和婴儿中报告的激素性质的轻度不良经历的发生率略高。这些儿童中,82%被跟踪到1.5岁,50%被跟踪到2.5岁。结论使用地索孕酮75μg/d不改变母乳的量和成分,也不影响母乳喂养儿童的生长发育。对于哺乳期妇女来说,这似乎是一种安全有效的避孕方法
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