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  • Title: A randomized controlled trial of intramuscular versus vaginal progesterone for the prevention of recurrent preterm birth.
    Author: Elimian A, Smith K, Williams M, Knudtson E, Goodman JR, Escobedo MB.
    Journal: Int J Gynaecol Obstet; 2016 Aug; 134(2):169-72. PubMed ID: 27168167.
    Abstract:
    OBJECTIVE: To compare the efficacy of intramuscular hydroxyprogesterone caproate with that of vaginal progesterone for prevention of recurrent preterm birth. METHODS: A prospective randomized controlled trial was conducted at a US tertiary care center between June 1, 2007, and April 30, 2010. Women with singleton pregnancies (16-20 weeks) and a history of spontaneous preterm birth were randomly allocated using a computer-generated randomization sequence to receive either a weekly intramuscular injection of hydroxyprogesterone caproate (250 mg) or a daily vaginal progesterone suppository (100 mg). Participants, investigators, and assessors were not masked to group assignment. The primary outcome was birth before 37 weeks of pregnancy. Per-protocol analyses were performed: participants who completed follow-up were included. RESULTS: Analyses included 66 women given intramuscular progesterone and 79 given vaginal progesterone. Delivery before 37 weeks was recorded among 29 (43.9%) women in the intramuscular progesterone group and 30 (37.9%) in the vaginal progesterone group (P=0.50). CONCLUSION: Weekly intramuscular administration of hydroxyprogesterone caproate and daily vaginal administration of a progesterone suppository exhibited similar efficacy in reducing the rate of recurrent preterm birth. ClinicalTrials.gov: NCT00579553.
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