Methods |
Double blind randomized controlled trial |
Double blind randomized controlled trial |
Double blind randomized controlled trial |
|
Location |
Egypt |
United States |
India |
|
Sample size |
205 |
33 |
148 |
|
Oral progesterone dose |
100 mg every 6 hrs until 37 wks gestation
(N=103) |
400 mg twice daily until 34 wks gestation
(N=19) |
100 mg twice daily until 36 wks gestation
(N=74) |
|
Comparator |
Placebo (N=102) |
Placebo (N=14) |
Placebo (N=74) |
|
Gestational age range at randomization |
14–18 Wks |
16–20 Wks |
18–24 Wks |
|
Inclusion criteria |
Singleton gestation 14–18 wks, previous
spontaneous preterm birth at <37 wks gestation |
Singleton gestation <20 wks, previous
spontaneous preterm birth at 20–36 wks 6 d |
Singleton gestation 18–24 wks, previous
spontaneous preterm birth at 16–36 wks 6 d |
|
Assessment of cervical length |
Cervical length ultrasound scan at 20 wks
gestation |
Cervical length ultrasound scan at least once
at <24 wks gestation, every 2 wks if cervical length was
10–25 mm, weekly for cervical length <10 mm |
Cervical length assessment in second
trimester |
|
Management of short cervix |
Cerclage offered for cervical length
<15 mm |
Cerclage offered for cervical length <5
mm |
Not reported |
|
Primary outcome |
Preterm birth at <37 wks gestation |
Preterm birth at <37 wks gestation |
Mean prolongation of pregnancy |