Maternal Committee Statement on Progesterone (17P):
Recently, an FDA advisory committee recommended that Makena (hydroxyprogesterone caproate injections) be removed from the market because the confirmatory trial (PROLONG) required for full FDA approval failed to show benefit in reducing recurrent preterm birth. While we await the FDA’s decision, as well as planned meta-analyses and secondary analyses of the data, UWNQC joins ACOG and SMFM recommending that current practice remain the same.
Specifically, pregnant women with a history of spontaneous preterm birth should be offered progesterone supplementation. Women who are currently using hydroxyprogesterone caproate injections may safely continue. Women who are at risk of recurrent preterm birth may continue to choose between weekly hydroxyprogesterone caproate injections or vaginal progesterone (100mg suppository nightly) from 16-20 weeks through 36 weeks after a discussion about their personal preferences and logistical considerations.
UWNQC will continue to monitor the discussion and offer updated recommendations as appropriate.
The goal of this committee is to reduce the incidence of recurrent spontaneous preterm births by increasing provider discussions with eligible women on the appropriate use of the progesterone 17P. The Utah Women and Newborns Quality Collaborative (UWNQC) Preterm Birth Prevention Video Series is intended to educate providers about Preterm Birth and to provide resources about prevention.
Introduction: Angela Anderson, Certified Nurse Midwife, Doctoral Degree in Nursing and UWNQC Board Chair, introduces the series and gives some basic information about Preterm Birth.
Preterm Birth and Progesterone: Sean Esplin, MD, and Maternal Committee Medical Director speaks about Preterm Birth risk factors and gives information about 17 alpha hydroxy progesterone caproate (17P) and other progesterones.
How to Obtain Progesterone: Sean Esplin, MD, and Maternal Committee Medical Director discusses how to get patients their progesterone for prevention of preterm birth.
The 17P prescription should read:
- “17-progesterone 250mg/ml. 1ml IM weekly, Duration 20 weeks, Start at 16 weeks gestation”. (Synonyms include “hydroxyprogesterone caproate” “17 alpha-hydroxy progesterone” and “17 hydroxy progesterone”)
Use ICD10 code:
- “O09.212, supervision of high risk pregnancy in the second trimester”
- Or “O09.219, supervision of high risk pregnancy with history of preterm labor, unspecified trimester”
- “O09.213, supervision of high risk pregnancy with history of preterm birth in the third trimester”
Cervical Length and Cerclage: Helen Feltovich, MD talks about the role of cervical length measurement and cerclage for prevention of preterm birth.
Counseling After a Preterm Birth: Erin Clark, MD and Out of Hospital/Community Births Committee Medical Director, talks about the importance of counseling with patients postpartum who have had a preterm birth.
Immediate Postpartum Long Acting Reversible Contraception (LARC): David Turok, MD, MPH, talks about the role of family planning and speaking to patients about immediate postpartum long-acting reversible contraception.