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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)
•   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
Perinatal outcome in women treated with progesterone for
        the prevention of preterm birth: a meta-analysis
                     Sotiriadis et al., UOG 2012




The aim of this meta-analysis was to systematically
   review published evidence and pool data on the
perinatal outcome in women treated with progesterone
           for the prevention of preterm birth
Perinatal outcome in women treated with progesterone for
                 the prevention of preterm birth: a meta-analysis
                                 Sotiriadis et al., UOG 2012


                                      Methods
Search 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 placebo

Inclusion criteria                               Exclusion criteria

1) Randomized controlled trials (RCTs)           1) No adequate randomization
2) Intervention: progesterone vs.
                                                 2) No placebo group
   placebo
3) 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
Perinatal outcome in women treated with progesterone for
     the prevention of preterm birth: a meta-analysis
                     Sotiriadis et al., UOG 2012



Primary outcome:

- neonatal mortality
number of deaths from birth to less than 28 days of age


Secondary outcomes:

- perinatal complications
respiratory distress syndrome, intraventricular hemorrhage,
necrotizing enterocolitis, sepsis, retinopathy and NICU admission

- composite adverse outcome
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
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.
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                 NNT

Composite adverse outcome        0.576               0.373–0.891                17
                                                                                      †Primary
          RDS                    0.464               0.275–0.786                15       study
                                                                                      outcome
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                      39


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

  • 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. 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. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012 The aim of this meta-analysis was to systematically review published evidence and pool data on the perinatal outcome in women treated with progesterone for the prevention of preterm birth
  • 4. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012 Methods Search 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 placebo Inclusion criteria Exclusion criteria 1) Randomized controlled trials (RCTs) 1) No adequate randomization 2) Intervention: progesterone vs. 2) No placebo group placebo 3) 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. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis Sotiriadis et al., UOG 2012 Primary outcome: - neonatal mortality number of deaths from birth to less than 28 days of age Secondary outcomes: - perinatal complications respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, retinopathy and NICU admission - composite adverse outcome
  • 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. 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. 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 NNT Composite adverse outcome 0.576 0.373–0.891 17 †Primary RDS 0.464 0.275–0.786 15 study outcome
  • 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 39 Progesterone 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. 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. 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. 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?