CTNPT 025: ProSPAR

About The Study

This pilot study was conducted to identify whether the addition of progesterone will improve standard care for pregnant women living with HIV. It aimed to determine how safe, well-tolerated, easy-to-use, and acceptable progesterone supplementation is for pregnant women living with HIV. This study involved the participants continuing the usual treatment for HIV-positive pregnant women (including anti-retroviral therapy, or ART), and if assigned to the treatment group, taking progesterone.

About The Disease

Standard care for pregnant women living with HIV involves taking ART medication to prevent mother-to-child transmission and promote maternal health. In Canada, the majority of pregnant women living with HIV are on ritonavir-boosted, protease inhibitor-based ART. However, multiple studies have shown that this therapy may increase the chances of delivering pre-term (when the baby is born before the 37^th week of pregnancy), having a low-birth-weight baby (when the baby weighs less than 2.5 kilograms or 5.5 pounds), or a baby that is small for gestational age (birth weight less than the 10th percentile for gestational age).

Previous research suggests that protease inhibitors may lead to a decrease in progesterone. Progesterone is a very important hormone during pregnancy because it helps maintain a supportive environment for a growing baby. Lower levels of progesterone during pregnancy as a result of protease inhibitor-based ART might contribute to the increased rate of early and low-birth weight deliveries. Supplementing women with progesterone during pregnancy may improve their chances of having a normal weight baby.

In the general population, progesterone supplementation (i.e., Prometrium) is widely used to help prevent a pre-term delivery, especially in pregnant women who have had a pre-term delivery in the past. Progesterone supplementation in pregnancy is well-tolerated and considered safe.

Study Approach

The study aimed to compare a group of 25 women who would receive natural progesterone (Prometrium 200mg) alongside standard care, with another group of 15 women who would simply continue with standard care alone.

Results

Unfortunately, this study was closed due to poor enrolment.

A preliminary review of existing research found that pregnant women living with HIV on antiretroviral therapy have an increased risk of preterm birth, low birthweight, and small-for-gestational age in high resource countries, as well as preterm birth and low birthweight in low-income countries, compared with HIV-negative controls.