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#Grand Rounds

Can Oral Micronized Progesterone Prevent Preterm Labor? 

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BACKGROUND AND PURPOSE: 

  • Interventions proven to reduce incidence of preterm delivery and/or neonatal complications related to prematurity include
    • Single embryo transfers resulting in fewer multiple births  
    • Limiting elective delivery in the late preterm and early term  
    • Specialty preterm birth prevention clinics 
    • Reducing maternal exposure to smoke/smoking via legislation and education 
    • Cervical cerclage  
    • Progesterone supplementation 
  • Oral progesterone was the first and least studied route
  • Micronization increases the bioavailability of oral progesterone 
  • Ashoush et al. (Acta Obstet Gynecol Scand., 2017) assessed the role and optimal dosage of micronized progesterone 

METHODS: 

  • Prospective, double-blind, randomized control trial 
  • Patients were randomized into either 
    • Progesterone group  
      • 100 mg oral micronized progesterone, six-hourly, starting at 14-18 weeks until 37 weeks or delivery 
    • Placebo: Identical oral capsules  
  • Protocol 
    • Progesterone levels were checked at 20 and 28 weeks 
    • Transvaginal ultrasound was done at 20 weeks for cervical length assessment 
    • Emergency/rescue cervical cerclage was done for those with a cervical length <15 mm 
    • Follow-up scans were continued till 28 weeks (twice monthly) for those with a cervical length of 20–25 mm and weekly for shorter cervical lengths 
  • Primary outcome 
    • Rate of spontaneous preterm delivery 
  • Secondary outcomes 
    • Gestational age at birth  
    • NICU admission 

RESULTS: 

  • 212 patients with previous spontaneous preterm delivery were randomized  
  • Comparing progesterone group to placebo group  
    • Women delivered at a later gestational age  
      • 35.4 weeks vs 33.9 weeks, p = 0.01  
    • Tocolysis-to-delivery intervals were longer
      • 87 days vs 36 days, p < 0.001 
    • Spontaneous preterm delivery was reduced
      • Relative risk (RR) of 0.7 (95% CI 0.54-0.92; p = 0.01) 
    • Neonatal mortality rates were lower 
      •  7.3% vs 25.2%, p < 0.001 
    • NICU admissions were shorter 
      • 15.4 days vs 19.5 days, p = 0.008 
  • Number needed-to-treat (NTT) to prevent one case of spontaneous preterm delivery was 5 (95% CI 3-20) 
  • The two groups had similar rates of operative delivery and postpartum complications 
  • Adverse events related to progesterone 
    • Mild maternal dizziness (29.1% vs. 9.8%, p = 0.002) 
    • Somnolence (41.6% vs. 19.7%, p = 0.002) 
    • Vaginal dryness (20.8% vs. 8.7%, p = 0.03) 

CONCLUSION: 

  • Oral micronized progesterone is effective in preventing spontaneous preterm delivery 
  • There may be advantage to oral administration due to affordability, and high safety profile 
  • The authors state that further research on the oral route is warranted 

Learn More – Primary Sources:  

The value of oral micronized progesterone in the prevention of recurrent spontaneous preterm birth: a randomized controlled trial

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Related ObG Topics:

SMFM Statement: Choice of Progestogen for Preterm Birth Prevention
Does Vaginal Progesterone Improve Birth Outcomes for Mothers with Short Cervix?
Vaginal Progesterone to Prevent Preterm Birth in Twins
Do Progestogens Prevent Preterm Birth in Symptomatic Pregnancies with a Short Cervix?
17-OHPC Treatment and Prevention of Preterm Birth: Does Timing Matter?

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