Table 1.
| Trial feature | Industry | Academic | United States government | Chi2P value |
|---|---|---|---|---|
| Total | 290 (6.8) | 3655 (85.6) | 331 (7.7) | |
| Primary purpose | ||||
| Treatment | 116 (40.0) | 1467 (40.1) | 98 (29.6) | .0002 |
| Basic science | 5 (1.7) | 84 (2.3) | 17 (5.1) | |
| Prevention | 92 (31.7) | 1119 (30.6) | 134 (40.5) | |
| Otherc | 67 (23.1) | 894 (24.5) | 76 (23.0) | |
| Missing | 10 (3.4) | 91 (2.5) | 6 (1.8) | |
| Phase | ||||
| Not Applicabled | 127 (43.8) | 2455 (67.2) | 223 (67.4) | <.0001 |
| Phase 1 | 13 (4.5) | 107 (2.9) | 16 (4.8) | |
| Phase 1/2–2 | 46 (15.9) | 221 (6.0) | 34 (10.3) | |
| Phase 2/3–3 | 58 (20.0) | 414 (11.3) | 35 (10.6) | |
| Phase 4 | 46 (15.9) | 458 (12.5) | 23 (6.9) | |
| Enrollmente | ||||
| 0–9 | 25 (8.6) | 169 (4.6) | 10 (3.0) | <.0001 |
| 10–49 | 57 (19.7) | 545 (14.9) | 39 (11.8) | |
| 50–99 | 38 (13.1) | 698 (19.1) | 53 (16.0) | |
| 100–499 | 115 (39.7) | 1655 (45.3) | 140 (42.3) | |
| 500–999 | 24 (8.3) | 237 (6.5) | 34 (10.3) | |
| >999 | 30 (10.3) | 337 (9.2) | 55 (16.6) | |
| Missing | 1 (0.3) | 14 (0.4) | 0 | |
| Blinding | ||||
| None | 166 (57.2) | 1926 (52.7) | 174 (52.6) | <.0001 |
| Single | 31 (10.7) | 947 (25.9) | 100 (30.2) | |
| Double | 93 (32.1) | 773 (21.1) | 56 (16.9) | |
| Missing | 0 | 9 (0.2) | 1 (0.3) | |
| Randomization | ||||
| Nonrandomized | 80 (27.6) | 706 (19.3) | 36 (10.9) | <.0001 |
| Randomized | 207 (71.4) | 2918 (79.8) | 295 (89.1) | |
| Missing | 3 (1.0) | 31 (0.8) | 0 | |
| Oversight by a data safety monitoring committee | ||||
| No | 155 (53.4) | 1976 (54.1) | 138 (41.7) | <.0001 |
| Yes | 120 (41.4) | 1341 (36.7) | 174 (52.6) | |
| Missing | 15 (5.2) | 338 (9.2) | 19 (5.7) | |
| Location | ||||
| High-income countries | 210 (72.4) | 2125 (58.1) | 222 (67.1) | <.0001 |
| Low- and middle-income countries only | 47 (16.2) | 1048 (28.7) | 79 (23.9) | |
| Missing | 33 (11.4) | 482 (13.2) | 30 (9.1) | |
| Therapeutic focusf | ||||
| Infection | 55 (19.0) | 283 (7.7) | 100 (30.2) | <.0001 |
| Nutrition | 40 (13.8) | 458 (12.5) | 55 (16.6) | .10 |
| Fetal | 27 (9.3) | 378 (10.3) | 17 (5.1) | .009 |
| Early delivery | 25 (8.6) | 292 (8.0) | 11 (3.3) | .002 |
| Diabetes mellitus | 22 (7.6) | 266 (7.3) | 19 (5.7) | .56 |
| Mental health | 21 (7.2) | 267 (7.3) | 66 (19.9) | <.0001 |
| Cesarean delivery | 19 (6.6) | 659 (18.0) | 8 (2.4) | <.0001 |
| Labor Augmentation | 19 (6.6) | 235 (6.4) | 3 (0.9) | .0002 |
| Hemorrhage | 19 (6.6) | 281 (7.7) | 5 (1.5) | .0001 |
| Hypertension | 13 (4.5) | 229 (6.3) | 12 (3.6) | .08 |
| Breastfeeding | 10 (3.4) | 158 (4.3) | 29 (8.8) | .0006 |
| Anesthesia | 10 (3.4) | 501 (13.7) | 4 (1.2) | <.0001 |
| Trauma | 7 (2.4) | 85 (2.3) | 3 (0.9) | .24 |
| Pregnancy loss | 6 (2.1) | 139 (3.8) | 4 (1.2) | .02 |
| Thromboembolic | 3 (1.0) | 21 (0.6) | 0 | .22 |
| Vomiting | 2 (0.7) | 17 (0.5) | 2 (0.6) | .83 |
| Other | 37 (12.8) | 441 (12.1) | 44 (13.3) | .77 |
Values are number (percentage) unless indicated otherwise.
Steinberg et al. The obstetrical clinical trial landscape. AJOG MFM 2021.
Percentages may not sum up to 100 because of rounding
Funding categories were determined with data on the sponsor and collaborators. Industry funding includes trials with an industry sponsor or collaborating agency. United States government trials include remaining trials with a United States government sponsor or collaborating agency. Academic trials include all other trials
Other primary purposes include diagnostic, screening, supportive care, health services research, and other
On ClinicalTrials.gov, “Not Applicable” is used to describe trials without Food and Drug Administration–defined phases, including trials of devices or behavioral interventions
Enrollment included both actual enrollment (for completed trials) and anticipated enrollment (for ongoing trials with continued enrollment)
Trials could have >1 therapeutic focus. For analysis, each therapeutic focus was treated as a binary variable.