Progesterone vaginal ring for contraception during lactation

Among lactating women during the first postpartum year, the contraceptive efficacy and safety of the 3-month progesterone vaginal ring (PVR) is comparable to the Copper-T380A intrauterine device (IUD), which lasts up to 12 years, according to a multicenter study in India.¹

The open-label study enrolled 789 healthy, married lactating women (aged 20 to 35 years; mean age 24) at 20 centers in India. All the women were 6 to 9 weeks postpartum following the birth of a normal, healthy infant, exclusively breastfeeding and willing to continue breastfeeding at least four times daily for 1 year.

Participants also had not used any contraceptives since delivery, but were at risk for pregnancy.

Of the women, 459 used the PVR and 330 the IUD. No significant difference was seen between the two groups in 1-year pregnancy rates using either the Pearl Index (PI) for incidence of pregnancy per 100 women-years nor Kaplan-Meier (K-M) life tables. (PI: 0.62 for PVR and 0.35 for IUD vs. for K-M: 0.7 for PVR and 0.4 for IUD (P = 0.58).

Overall, 99.3% of PVR users and 99.6% of IUD users avoided pregnancy. But contraceptive continuation rates at 12 months were 78.5% for IUD compared to only 56.9% for the PVR (P < 0.001).

“This outcome was due primarily to expulsions that occurred during toileting and other squatting activities within the first three months and non-replacement of lost rings consistent with the protocol, a stipulation that limited comparisons and comparability of the two study arms,” the authors wrote.

Ring expulsions and menorrhagia were the two most common reasons for discontinuation among PVR and IUD users, respectively. However, few women (4 PVR users and 0 IUD users) reported weaning as a reason for discontinuation.

Median duration of amenorrhea among PVR users was 405 days versus 120 days for IUD users (P < 0.001). Infants from both groups were fed seven to 12 times daily and grew at expected rates. The study underscores the value of PVR as a method that promotes breastfeeding as being beneficial to infant health.

Both groups reported similar treatment-emergent adverse events (TEAEs): 24.2% of PRV users and 23.0% of IUD users. Five PVR users experienced severe TEAEs: three cases of menorrhagia and one case each of dizziness and vaginal ulceration. This compared to three IUD users with severe TEAEs: one each of extremity pain, seizure and menometrorrhagia/menorrhagia.

Ensuring access to safe and effective contraception for postpartum women is an important national goal for India because only one-quarter of the country’s postpartum population is using contraception. In addition, short pregnancy intervals increase the risks of adverse maternal and infant outcomes.

In 2015, the World Health Organization (WHO) said that women who breastfeed and are 4 or more weeks postpartum can use the PVR without restriction. The authors concluded that a user-controlled device like the PVR “offers an additional contraceptive choice for lactating women for one-year postpartum use and can help to address the unmet need for contraception among postpartum women while encouraging breastfeeding to enhance infant growth and well-being.”

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Reference

1. Roy M, Hazra A, Merkataz R, et al. Progesterone vaginal ring as a new contraceptive option for lactating mothers: evidence from a multicenter non-randomized comparative clinical trial in India. Contraception. Published online May 1, 2020. doi:org/10.1016/j.contraception.2020.04.016