UOG Journal Club: Perinatal outcome in women treated with progesterone for the prevention of preterm birth

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This Journal Club presentation provides a summary and discussion of the following free access article published in UOG:

Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis
A. Sotiriadis, S. Papatheodrou, G. Makrydimas
Volume 40, Issue 3, Date: September 2012, pages 257-266

It can be accessed here:
http://onlinelibrary.wiley.com/doi/10.1002/uog.11178/abstract

Published in: Health & Medicine
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UOG Journal Club: Perinatal outcome in women treated with progesterone for the prevention of preterm birth

  1. 1. UOG Journal Club: September 2012 Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis A, Papatheodorou S, Makrydimas G Volume 40, Issue 3, Date: September 2012, pages 257–266 Journal Club slides prepared by Dr Aly Youssef (UOG Editor for Trainees)
  2. 2. • Preterm birth (PTB) is the leading cause of neonatal mortality and the most common reason for antenatal hospitalization• Screening for PTB based on obstetric history and cervical length can identify more than 50% of those who will deliver <34 weeks• Progesterone prophylaxis clearly reduces the risk of preterm birth in women at risk• Nevertheless, its effects on the actual perinatal and long-term consequences of prematurity are more difficult to assess Centre for Maternal and Child Enquiries (CMACE) Perinatal Mortality 2009:UK Martin JA et al., Natl Vital Stat Rep 2010
  3. 3. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012The aim of this meta-analysis was to systematically review published evidence and pool data on theperinatal outcome in women treated with progesterone for the prevention of preterm birth
  4. 4. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012 MethodsSearch of the literature (last update December 2011) for clinical trials in which progesterone was given for the prevention of PTB in pregnant women at risk compared to placeboInclusion criteria Exclusion criteria1) Randomized controlled trials (RCTs) 1) No adequate randomization2) Intervention: progesterone vs. 2) No placebo group placebo3) Type of participants: singleton 3) Women with symptoms of PTB, pregnancy at risk for preterm birth bleeding or rupture of membranes due to previous history or short cervix during the second trimester or 4) Studies that did not provide data on multiple pregnancies neonatal outcomes
  5. 5. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012Primary outcome:- neonatal mortalitynumber of deaths from birth to less than 28 days of ageSecondary outcomes:- perinatal complicationsrespiratory distress syndrome, intraventricular hemorrhage,necrotizing enterocolitis, sepsis, retinopathy and NICU admission- composite adverse outcome
  6. 6. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012 Results MEDLINE, SCOPUS, EMBASE search 628 articles 458 articles: excluded based on title and abstract 170 articles Reviews: 79 Letters, Editorials, Notes, Guidelines: 18 No placebo group or other outcomes: 39 Symptomatic women: 6 Overlapping: 3 No neonatal outcomes: 8 No separate data on twins and singleton: 1 16 studies included in the meta-analysis
  7. 7. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012 Results: singleton pregnancies, all indications, all progestogens (6 RCTs) Outcome RR 95% CI NNT Neonatal death † 0.487 0.290–0.818 57 Composite adverse outcome 0.576 0.373–0.891 17 RDS 0.677 0.490–0.935 26 NICU admission 0.410 0.204–0.823 4 Birth <34 weeks 0.577 0.427–0.779 6 No significant difference was found in the rates of perinatal death, grade III-IV intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy and sepsis.†Primary study outcome. NICU, neonatal intensive care unit; NNT, number needed to treat; RDS, repiratory distress syndrome.
  8. 8. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012 Results: singleton pregnancies subgroup analysis The available data allowed only two subgroup analyses I. Singleton pregnancies with history of PTB treated with systemic progesterone (3 RCTs) Outcome RR 95% CI NNT Neonatal death † 0.412 0.201–0.842 24 NICU admission 0.277 0.160–0.479 3 II. Singleton pregnancies with a short cervix in the second trimester treated with local (vaginal) progesterone (3 RCTs) Outcome RR 95% CI NNTComposite adverse outcome 0.576 0.373–0.891 17 †Primary RDS 0.464 0.275–0.786 15 study outcome
  9. 9. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012 Results: twin pregnancies, all progestogens (7 RCTs) Outcome* RR 95% CI NNH†Composite adverse outcome 1.211 1.029–1.425 31 Perinatal death 1.551 1.014–2.372 71 RDS 1.218 1.038–1.428 39Progesterone administration did not significantly affect the rates of neonatal death, grade III-IV IVH, NEC, retinopathy, sepsis and NICU admission.Triplet pregnancies: The pooled data of 2 RCTs did not show significant differences in the rates of composite adverse outcome, neonatal death, RDS, grade III-IV IVH, NEC and sepsis †NNH, number needed to harm.
  10. 10. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012 Discussion• The present meta-analysis focused on the effects of progesterone on the actual perinatal outcomes of treated pregnancies• Prophylactic progesterone administration in singleton pregnancies at risk succeeds in reducing the rates of neonatal mortality, RDS, admission to the NICU and composite adverse outcome• Whether local or systemic progesterone is better for women with a short cervix remains to be answered• In multiple pregnancies, no beneficial effect of progesterone was demonstrated and in fact the rates of perinatal death, RDS and composite adverse outcome may even be increased
  11. 11. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012 Limitations• Pooled studies cannot have identical inclusion criteria, treatment and reporting protocols. However, in the present meta-analysis there was marked consistency in the results across studies for most outcomes• The relatively small number of triplets prevented reaching statistically significant results in this group Future perspectives• The next step after testing the effects of progesterone treatment on the rates of preterm birth and immediate perinatal complications is to examine its impact on the longer-term neurodevelopment of treated children
  12. 12. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012 Discussion points• Should a policy of universal screening of pregnant women for PTB and progesterone prophylaxis be implemented?• What level of cut-off for cervical length should be used to define a woman with a singleton pregnancy as “high-risk” for PTB?• In women with short cervices, which progesterone (local/systemic) should be used?• Are there any beneficial measures for the prevention of PTB in twin pregnancies?• Does the available data support the application of preventative measures of PTB in multiple pregnancies?

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