Table 1.
Characteristics of Included Studies Examining the Effect of 17α-Hydroxyprogesterone Caproate on Glucose Intolerance and Rate of Gestational Diabetes Mellitus
Gyamfi et al12 | Nelson et al5 | Rebarber et al10 |
Rouholamin et al13 |
Waters et al11 | Wolfe et al14 | |
---|---|---|---|---|---|---|
Study type | Secondary analysis of 2 RCTs | Prospective cohort | Retrospective cohort | RCT | Retrospective cohort | Prospective cohort study |
Study country | United States | United States | United States | Iran | United States | United States |
Sample size | 441 | 1,720 | 2,081 | 164 | 440 | 207 |
17α-OHPC dose (mg/wk) | 250 | 250 | 250 | 250 | 250 | 250 |
Control group | No 17 α -OHPC | No 17 α -OHPC | No 17 α -OHPC | No 17 α -OHPC | No 17 α -OHPC | No 17 α -OHPC |
Gestational age at 17 α -OHPC initiation (wk) | 16–20 | 16–20 | 16–20 | 16–20 | 16–20 | 16–20 |
OGTT testing algorithm | Criteria for diagnosis of GDM not predefined* | 1-h, 50-g test; GDM diagnosis with 100-mg, 3-h test | 1-h, 50-g test; GDM diagnosis with 100-mg, 3-h test | 1-h, 50-g test; GDM diagnosis with 100-mg, 3-h test | 1-h, 50-g test; GDM diagnosis with 100-mg, 3-h test | 1-h, 50-g test; GDM diagnosis with 100-mg, 3-h test |
Inclusion criteria | Singleton, history of prior PTB at less than 36 wk | Singleton, history of prior PTB at less than 35 wk | Singleton, history of prior PTB at less than 37 wk | Singleton, history of prior PTB at less than 37 wk | Singleton, history of prior PTB at less than 37 wk | Singleton, history of prior PTB at less than 37 wk |
Exclusion criteria | Multiple gestation, pregestational DM, unknown GDM diagnosis, lost to follow-up | Multiple gestation, pregnancy induced hypertension, placental abruption | Multiple gestation, pregestational DM, unknown GDM | Multiple gestation, BMI greater than 30, abnormal OGTT, family history of DM, unknown GDM | Multiple gestation, pregestational DM, unknown GDM | Multiple gestation, progestational diabetes, unknown GDM, younger than 18 or older than 50 y. |
RCT, randomized controlled trial; 17 α -OHPC, 17 α-hydroxyprogesterone caproate; OGTT, oral glucose tolerance test; GDM, gestational diabetes mellitus; PTB, preterm birth; BMI, body mass index; DM, diabetes mellitus.
Because this is a secondary analysis, criteria for diagnosis of GDM were not predefined. However, the centers that participated in the original study used similar guidelines to diagnose GDM.