17 alpha-hydroxyprogesterone caproate
(17p, Delalutin®, Makena ®)

17P is a synthetic progesterone used to help decrease the chance of preterm birth in women with a single  pregnancy who have a history of single spontaneous preterm birth. 17p does not appear to be effective in preventing preterm delivery in  twin pregnancies.  Long term studies are limited, but one study found  no significant differences  in the health status or physical examination of  children ,at 48 months of age ,whose mothers were given  17 alpha-hydroxyprogesterone caproate versus women who received placebo during pregnancy .

17 P is given intramuscularly at a dose of 250 mg (1 mL) once weekly Treatment is started between 16 weeks, 0 days and 20 weeks, 6 days of gestation and continued until week 37 weeks of gestation or delivery, whichever occurs first. Some studies suggest 17 P may be effective if started  as late as 27 weeks gestation

The most common side effects are pain , swelling, and itching at the site of the injection. Diarrhea , fluid retention, jaundice, high blood pressure, elevated blood sugars , worsening of blood sugar control, and depression may also occur.

Women with the following problems should not receive 17 P

  • Current or history of thrombosis or thromboembolic disorders
  • Known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions
  • Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
  • Cholestatic jaundice of pregnancy
  • Liver tumors, benign or malignant, or active liver disease
  • Uncontrolled hypertension

17 alpha-hydroxyprogesterone caproate (17 OHP-C) was originally approved under the trade name Delalutin® (NDA 10-347) for use in pregnant women for the treatment of habitual and recurrent abortion, threatened abortion, and post-partum “after pains”. 

17 P is now marketed under the tradename Makena ® and may be covered by insurance. If Makena  ® is covered by your insurance and you are eligible to receive Makena  ®  ask your doctor to arrange to have the injections (shots)



References:
Prediction and prevention of preterm birth. Practice Bulletin No. 130. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012;120:964–73.PMID:22996126
How HY et al. ,Prophylaxis with 17 alpha-hydroxyprogesterone caproate for prevention of recurrent preterm delivery: does gestational age at initiation of treatment matter?Am J Obstet Gynecol. 2007;197:260.e1-4.PMID:17826411
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a1998c1d-8337-4f00-8dcb-af3b54d39b77
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249025.htm
Northen AT, et al. Follow-up of Children Exposed In Utero to 17 {alpha}-Hydroxyprogesterone Caproate Compared With Placebo.Obstet Gynecol. 2007 ;110:865-872. PMID:17906021