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Table 1 Provisional list of trials potentially eligible for inclusion in EPPPIC (progestogen versus placebo/usual care). This table will be updated as new trials are identified. Publication details for individual trials are available on request

From: Evaluating progestogens for prevention of preterm birth international collaborative (EPPPIC) individual participant data (IPD) meta-analysis: protocol

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
  1. aEligibility as of 15/07/2017, eligibility of all trials subject to final confirmation. Abbreviations used: IVF/ICSI in vitro fertilization/intracytoplasmic sperm injection, N number randomized, SPTB spontaneous preterm birth, IMI intramuscular injection, SA spontaneous abortion, FFT fetal fibronectin test
  2. bAnalyzed, not randomized (number randomized unclear)