HRA Pharma, 200 Avenue de Paris, 92320 Châtillon, France.
Dinox GmbH, Anklamer Strasse 38, 10115 Berlin, Germany.
Contraception. 2020 Sep;102(3):145-151. doi: 10.1016/j.contraception.2020.05.013. Epub 2020 May 29.
Among combined oral contraception (COC) users, to determine the effect on ovarian activity and ovulation of waiting five days before restarting COC, versus restarting immediately, having taken ulipristal acetate 30 mg (UPA, the dose used for emergency contraception) after missing three consecutive COC pills.
Women already using COC were enrolled for two cycles of COC use (21/7 regimen). In cycle 2, all women omitted COC pills for three consecutive days (days 5,6,7), and on day 8 took UPA 30 mg. They were randomized either to restart their COC pills that same day (immediate restart) or to wait five days (delayed restart). Transvaginal ultrasound, and blood sampling for estradiol and progesterone were undertaken on days 4,8,11,13,15,18,22 and 26. A modified Hoogland score was used to quantify ovarian activity/ovulation and to assess whether luteal phase progesterone concentrations were sufficiently 'adequate' to have conferred a theoretical risk of pregnancy.
No one ovulated with risk of pregnancy during the five days following UPA. Among 26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle. Four of 23 women (17.4% CI [5.0; 38.8]) with delayed restart ovulated with theoretical risk of pregnancy before the end of the cycle. This difference was statistically significant (p = 0.042).
Women who delay restarting COC for five days after taking UPA 30 mg are at much greater risk of ovulation, and therefore theoretically of pregnancy, than if they restart their COC on the same day as taking UPA. Current recommendations should be revisited.
Women who take UPA-EC after having missed combined oral contraceptive pills are advised to wait five days before restarting the COC. This delay puts them at risk of ovulation and, if intercourse occurs, theoretically therefore of pregnancy. Women who restart their COC pills immediately are much less likely to ovulate. The label for UPA-EC and clinical guidelines on using EC after missed pills should be revisited.
在服用复方口服避孕药（COC）的女性中，确定在错过连续三天的 COC 后，等待五天再重新开始 COC 与立即重新开始 COC 相比，对卵巢活动和排卵的影响，同时服用了 30 毫克屈螺酮（用于紧急避孕的剂量）。
已经使用 COC 的女性入组进行了两个 COC 周期的使用（21/7 方案）。在第 2 个周期中，所有女性连续三天漏用 COC 药片（第 5、6、7 天），并在第 8 天服用 30 毫克 UPA。她们被随机分为当天立即重新开始（立即重新开始）或等待五天（延迟重新开始）。在第 4、8、11、13、15、18、22 和 26 天进行阴道超声检查和血液采样，以检测雌二醇和孕酮。采用改良的 Hoogland 评分来量化卵巢活动/排卵，并评估黄体期孕酮浓度是否足够“充足”，以产生理论上的妊娠风险。
在 UPA 后五天内，没有一个人排卵且有妊娠风险。在 26 名立即重新开始的女性中，在周期的任何时间都没有排卵且有理论妊娠风险。在延迟重新开始的 23 名女性中，有 4 名（95%CI [5.0; 38.8]）在周期结束前排卵且有理论妊娠风险。这种差异具有统计学意义（p=0.042）。
与服用 UPA 后同一天重新开始 COC 相比，服用 UPA 30 毫克后延迟五天重新开始 COC 的女性排卵的风险更大，因此理论上妊娠的风险也更大。目前的建议应该重新考虑。
服用 UPA-EC 后漏用 COC 的女性建议等待五天再重新开始 COC。这种延迟会增加排卵的风险，如果发生性行为，理论上就会怀孕。立即重新开始 COC 片的女性排卵的可能性较小。应重新考虑 UPA-EC 的标签和关于错过药丸后使用 EC 的临床指南。
