EPPPIC identifier | Trial setting | Recruitment years |
Progestogen type, dose, intervention, period Comparator |
Main indication(s) Gestation at randomization | Singleton/multiple pregnancy | N |
---|---|---|---|---|---|---|
A: Eligible trials comparing progestogen with standard care or placeboa | ||||||
1 |
Single center Egypt (Cairo) | 2008–2009 |
Vaginal Micronized progesterone 400 mg suppository daily 18–24 to 37 weeks Placebo |
First pregnancy by IVF/ICSI 18–24 weeks | SingletonTwin | 313 |
2 |
Single center Iran (Khorramabad) | – |
Vaginal Progesterone 100 mg daily 24 to 34 weeks Standard care |
Previous SPTBProphylactic cerclage Uterine anomalies Gestation unclear | Singleton | 150 |
3 |
Single center Lebanon (Beirut) | 2006–2012 |
Intramuscular injection 17-OHPC 250 mg weekly 16–20 to 36 weeks Castor oil |
Twin pregnancy 12–20 weeks | Twin | 293 |
4 |
Multi center USA | 2004–2006 |
Intramuscular injection 17-OHPC 250 mg weekly 16–20 to 35 weeks Castor oil |
Triplet pregnancy 16–20 weeks | Triplet | 134 |
5 |
Single center Turkey (Istanbul) | 2004–2007 |
Vaginal Progesterone 100 mg suppository daily 24 to 34 weeks Placebo |
Twin pregnancy Previous SPTB Uterine anomalies 24 weeks |
Singleton Twin | 160 |
6 |
Multi center USA | 2004–2008 |
Intramuscular injection 17-OHPC 250 mg weekly 16–24 to 34 weeks Castor oil |
Trichorionic-triamniotic triplet pregnancy 15–23 weeks | Triplet | 81 |
7 |
Multi center USA | 2004–2009 |
Intramuscular injection 17-OHPC 250 mg weekly 16–24 to 34 weeks Castor oil |
Dichorionic-diamniotic twin pregnancy 15–23 weeks | Twin | 240 |
8 |
Multi center Australia | 2005–2009 |
Vaginal Progesterone 100 mg suppository nightly 20–24 to 34 weeks Placebo |
SPTB preceding pregnancy 18–24 weeks | Singleton | 787 |
9 |
Single center Brazil (São Paulo) | 1996–2001 |
Vaginal Progesterone 100 mg suppository nightly 24 to 34 weeks Placebo |
Previous SPTBPrevious cerclage Uterine anomalies Gestation not reported | Singleton | 157 |
10 |
Single center Egypt (Cairo) | – |
Vaginal Progesterone 200 mg daily 24 to 34 weeks Placebo | Twin pregnancy | Twin | 100 |
11 |
Multi center International | 2003–2006 |
Vaginal Progesterone 200 mg suppository nightly 24–25 to 34 weeks Safflower oil |
Short cervix (≤15 mm) 20–25 weeks |
Singleton twin | 250 |
12 |
Single center Pilot USA (Ohio) | 2006–2009 |
Oral Micronized progesterone 2 × 200 mg capsule daily 16–20 to 34 weeks Placebo |
Previous live SPTB < 20 weeks | Singleton | b33 |
13 |
Multi center USA | 2007–2011 |
Intramuscular injection 17-OHPC 250 mg weekly 16–23 to 37 weeks Castor oil |
Nulliparous Short cervix (< 30 mm) 16–23 weeks | Singleton | 657 |
14 |
Single center Finland (Oulu) | – |
Intramuscular injection 17-OHPC 250 mg weekly 28–33 to 37 weeks Placebo |
Twin pregnancy 28–33 weeks | Twin | 77 |
15 |
Multi center International | 2008–2010 |
Vaginal Progesterone 90 mg gel daily 20–24 to 37 weeks Placebo | Short cervix (10–20 mm) 19–24 weeks | Singleton | 465 |
16 |
Single center Egypt (Cairo) | 2006–2008 |
Intramuscular injection 17-OHPC 250 mg weekly Second trimester to 36 weeks Saline |
Previous SPTB Second trimester | Singleton | 50 |
17 |
Single center USA (Baltimore) | – |
Intramuscular injection 17-OHPC 250 mg weekly Unclear to 37 weeks Castor oil + benzyl benzoate |
2 previous SPTB 2 SAs or (1 SPTB and 1 SA) in immediately preceding pregnancy < 24 weeks |
Singleton Twin | 50 |
18 |
Multi center Netherlands | 2006–2009 |
Intramuscular injection 17-OHPC 250 mg weekly 16–20 to 36 weeks Castor oil |
Multiple pregnancy 15–19 weeks |
Twin Triplet Quadruplet | 671 |
19 |
Single center India (Chandigarh) | 2004–2006 |
Vaginal Micronized progesterone 100 mg capsule nightly 20–24 to 36 weeks Standard care |
Previous singleton SPTB 16–24 weeks | Singleton | 100 |
20 |
Multi center USA | 1999–2002 |
Intramuscular injection 17-OHPC 250 mg weekly 16–20 to 36 weeks Castor oil |
Previous SPTB 15–21 weeks | Singleton | 463 |
21 |
Single center Albania (Tirana) | – |
Intramuscular injection 17-OHPC Dose not reported, daily 15–22 to 34 weeks Oral Progesterone daily (dose not reported, daily 15–22 to 34 weeks Placebo |
High risk of SPTB 15–22 weeks | – | 121 |
22 |
Multi center UK | 2004–2008 |
Vaginal Progesterone 90 mg gel daily 24 to 34 weeks Placebo |
Twin pregnancy 22 weeks | Twin | 500 |
23 |
Multi center UK | 2009–2013 |
Vaginal Progesterone 200 mg suppository nightly 22–24 to 34 weeks Placebo |
Previous SPTB Short cervix (≤ 25 mm) Positive FFT and other risk factors for SPTB | Singleton | 1228 |
24 |
Multi center USA | 2004–2007 |
Vaginal Progesterone 90 mg gel daily 18–23 to 37 weeks Vaginal moisturizer |
Singleton SPTB in most recent pregnancy 16–23 weeks | Singleton | 659 |
25 |
Single center Iran (Tehran) |
Intramuscular injection 17-OHPC 250 mg weekly 16–20 to 34 weeks Placebo | Women ≥ 35 years | – | 260 | |
26 |
Single center India (Delhi) | 2005–2006 |
Oral Micronized progesterone 100 mg capsule twice daily 18–24 to 36 weeks Placebo |
Previous SPTB 18–24 weeks | Singleton | 150 |
27 |
Multi center Denmark and Austria | 2006–2008 |
Vaginal Micronized progesterone 200 mg suppository daily 20–24 to 34 weeks Safflower oil, gelatine, glycerol, titanium dioxide (E171) |
Diamniotic twin pregnancy Chorionicity <16 weeks 18–24 weeks | Multiple | 677 |
28 |
Multi center USA | 2004–2006 |
Intramuscular injection 17-OHPC 250 mg weekly 16–20 to 35 weeks Castor oil |
Twin pregnancy 16–20 weeks | Twin | 661 |
29 |
Single center Iran (Mashhad) | 2007–2008 |
Intramuscular injection 17-OHPC 250 mg weekly 16 to 37 weeks Standard care |
Previous SPTB Not reported | Singleton | 100 |
30 |
Multi center France | 2006–2010 |
Intramuscular injection 17-OHPC 500 mg twice weekly 24–32 to 36 weeks Standard care |
Dichorionic diamniotic twin pregnancy Cervix ≤25 mm 24–32 weeks | Twin | 165 |
31 |
Multi center Spain | 2006–2008 |
Vaginal Progesterone (1) 2 × 200 mg suppository nightly (2) 1 × 200 mg + 1 × placebo suppository nightly 20 to 34 weeks (3) 2 x placebo suppository nighly Peanut oil + soy lecithin |
Dichorionic diamniotic twin pregnancy 20 weeks | Twin | 294 |
32 |
Two center Canada (Calgary) | 2006–2010 |
Vaginal Progesterone 90 mg gel daily 16–21 to 36 weeks Placebo |
Multiple gestation 16–21 weeks |
Twin Triplet | 84 |
33 |
Single center Brazil (São Paulo) | 2007–2013 |
Vaginal Progesterone 200 mg suppository nightly 18–21 to 34 weeks Placebo |
Naturally conceived diamniotic twin pregnancy 18–21 weeks | Twin | 390 |
34 |
Single center Iran (Tehran) | 2010–2012 |
Vaginal Progesterone 400 mg suppository nightly 16–22 to 36 weeks Placebo |
Previous SPTB Cervix ≤ 28 mm + cerclage Uterine anomalies Uterine intramural myoma ≥ 7 cm 16–22 weeks | Singleton | 103 |
35 |
Two center Egypt (Mansoura) | 2012–2014 |
Vaginal Progesterone 400 mg suppository daily 20–24 to 37 weeks Standard care |
Dichorionic twin pregnancy Cervix 20–25 mm 20–24 weeks | Twin | 250 |
36 |
Multi center Netherlands | 2009–2013 |
Vaginal Micronized progesterone 200 mg suppository daily 22 to 34 weeks Placebo |
Nulliparous Multiparous without SPTB < 34 weeks gestation Cervix ≤30 mm 18–22 weeks | Singleton | 80 |
37 |
Single center India (Shimla) | – |
Vaginal Progesterone 100 mg suppository 24–28 to 34 weeks Placebo |
Previous SPTB 24–28 weeks | Singleton | 80 |
38 |
Single center Pakistan (Bahalwapur) | 2011 |
Intramuscular injection 17P 250 mg weekly 16–20 to 36 weeks Placebo |
Previous SPTB 16–20 weeks | Singleton | 60 |
45 |
Single center USA (Jackson) | – |
Intramuscular injection 17-OHCP 250mg weekly Up to 34 weeks or delivery Castor oil |
Twin pregnancy 20–30 weeks | Twin | 30 |
B: Eligible trials comparing different types of progestogen | ||||||
21 |
Single center Albania (Tirana) | – |
Intramuscular injection 17-OHPC Dose not reported, daily 15–22 to 34 weeks Oral Progesterone daily (dose Dose not reported, daily 15–22 to 34 weeks Placebo |
High risk of SPTB 15–22 weeks | – | 121 |
39 |
Single center Egypt (Tanta) | 2010–2011 |
Vaginal Micronized progesterone 200 mg suppository daily 20–24 to 34 weeks Intramuscular injection Progesterone 100 mg every 3rd day 20–24 to 34 weeks |
Previous SPTB Cervix ≥ 15 mm 20–24 weeks | Singleton | 160 |
40 |
Single center Iran (Yazd) | 2012–2015 |
Vaginal Progesterone 200 mg suppository daily 16–20 to delivery Intramuscular injection 17-OHPC 250 mg weekly 16–20 weeks to delivery |
Previous SPTB or Cervix < 25 mm (not both) 16–20 weeks | Singleton | 78 |
41 |
Single center Saudi Arabia (Khamis Mushayt) | 2009–2011 |
Vaginal Micronized progesterone 90 mg gel daily 14–18 to 36 weeks Intramuscular injection 17-OHPC 250 mg weekly 14–18 to 36 weeks |
Previous mid-trimester SPTB Previous cerclage 14–18 weeks | Singleton | 518 |
42 |
Single center Iran (Tehran) | 2012–2015 |
Vaginal Progesterone 400 mg suppository daily 16–24 to 36 weeks 17-OHPC 250 mg weekly 16–24 to 36 weeks |
Cervix < 25 mm 16–24 weeks | Singleton | 304 |
43 |
Single center USA (Oklahoma) | 2007–2010 |
Intramuscular injection 17-OHPC 250 mg weekly 16–21 to 37 weeks Vaginal Micronized progesterone 100 mg suppository daily 16–21 to 37 weeks |
Previous live singleton SPTB 16–21 weeks | Singleton | 174 |
44 |
Single center Iran (Yazd) | 2010–2011 |
Intramuscular injection 17-OHPC 250 mg weekly 16 to 36 weeks Placebo |
Assisted conception 16 weeks | Singleton | 106 |