Population Briefs

Expanding Contraceptive Options for Breastfeeding Women: Introduction of the Progesterone Contraceptive Vaginal Ring

For the first several months after childbirth, exclusive breastfeeding is generally an effective method for delaying a subsequent pregnancy. Many postpartum women, however, do not or are not able to breastfeed exclusively. Once a woman begins supplementing her infant’s diet, stops breastfeeding, or resumes menstruation, she should use a family planning method if she wishes to space or limit childbearing.

In low-resource settings, breastfeeding postpartum women who wish to delay the next pregnancy often have limited options to access effective contraceptive methods that can be used during this time period. To address this need and expand safe and effective choices, the Population Council and partners developed the progesterone contraceptive vaginal ring (PCVR). It is made of silicone with progesterone dispersed throughout. Women insert this ring into the vagina, where it slowly releases a continuous low dose of the natural hormone progesterone which reinforces the inhibitory effect of breastfeeding on ovulation to prevent pregnancy and delays the return of menstruation. Each PCVR can be used continuously for three months, with additional vaginal rings used in succession for up to one year as long as the woman breastfeeds at least four times a day. The PCVR can be inserted and removed by the woman herself, reducing the need for involvement by skilled health care providers, and fertility returns rapidly after a woman stops using the ring.

Studies in numerous countries have shown that the PCVR is as effective as an intrauterine device (IUD) in preventing pregnancy as long as the woman is breastfeeding at least four times a day. Results have also demonstrated that the PCVR is safe for both mothers and babies and does not affect breast milk production. Currently the PCVR is approved and available in several Latin American countries, but it has the potential to be a useful option for more than 25 million breastfeeding women living in low-resource settings. A recent commentary by Population Council researchers published in Contraception makes the case for introducing the PCVR more widely in these settings and outlines the factors that will need to be addressed to ensure successful introduction of the ring.

Policy considerations

Like all health technologies, the PCVR can only be introduced and made available successfully when there is a supportive policy and regulatory environment. In their analysis, the authors of the Contraception commentary recommend:

  • educating national health policymakers about the PCVR, so they fully understand the technology, and how this contraceptive can fill a key niche in providing comprehensive family planning services and promoting maternal and child health;
  • establishing how the PCVR will be dispensed and by whom (for example, by community health workers or higher-level care providers only);
  • considering and identifying potential procurement and financing possibilities; and
  • obtaining World Health Organization (WHO) prequalification of the ring manufacturing, a common prerequisite among international procurers, which may support the provision of the PCVR.
Preparing the service environment

To ensure a smooth introduction of the technology once it is approved in various countries, several steps will need to be taken to prepare the service environment, including:

  • preparing and training clinic staff and providers about client counseling, PCVR insertion, and the conditions under which the product is effective
  • reviewing, evaluating, and modifying service guidelines, protocols, and practices
  • providing information about the PCVR to obstetricians and gynecologists, nurses and midwives, pharmacists (including those in the private sector), and potential users
Ensuring user acceptability

Even if the policy and service environments are supportive, women will only use the PCVR if they like it. Confirming acceptability is especially important because the PCVR is a different type of method compared with others commonly used by breastfeeding women, such as injectables and progestin-only pills. In the commentary, the authors cite data indicating that women generally find the PCVR easy to use, comfortable, and well-tolerated. Such data are encouraging and data from ongoing acceptability studies in India, Kenya, Nigeria, and Senegal will provide more information about women’s preferences.

Council studies to facilitate PCVR introduction

Although the PCVR is available to women in seven countries in Latin America, it is not yet approved for use in sub-Saharan Africa or Asia, where it has great potential for meeting the contraceptive needs of breastfeeding women. The Population Council is collaborating with partners in India, Kenya, Nigeria, and Senegal, to obtain regulatory approval and promote product introduction. The Council’s goal is to expand access to the PCVR in additional countries where there is a high unmet need for modern contraceptive technologies for postpartum, breastfeeding women. Council researchers involved in the studies in Africa are:

  • assessing interest in and support for the PCVR among policymakers, regulators, and others who determine which products are made available in their countries;
  • determining the acceptability of this ring among breastfeeding women, their partners, and providers; and
  • identifying and streamlining pathways for introducing the product if approved and understanding the market and product placement opportunities.

The Council is also conducting assessments in each country to determine the most appropriate sectors (public, private, non-profit, social marketing) in which to make the PCVR available. One of these initiatives is a market segmentation analysis using Demographic and Health Survey (DHS) data to determine the characteristics of women who may want to use the PCVR.

If the PCVR appears to have an appropriate role in the method mix of various countries, the Council will develop an introductory plan to bring the product into these and other low-resource settings, further contributing to the goal of reducing unmet need for contraception.


Source

RamaRao, Saumya, Heather Clark, Ruth Merkatz, Heather Sussman, and Régine Sitruk-Ware. 2013. “Progesterone vaginal ring: Introducing a contraceptive to meet the needs of breastfeeding women,” Contraception 88 (5): 591–598.