Table 1. Trial intervention and general characteristics by site.
| South Asia | Sub-Saharan Africa | Central and South America | |||||
|---|---|---|---|---|---|---|---|
|
|
|
|
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| India (Belgaum) | India (Nagpur) | Pakistan | Zambia | Kenya | Guatemala | Argentina | |
| Location of birth (n/N [%]) | |||||||
| Hospital | 11 548/18 175 (64%) | 6465/10 079 (64%) | 3422/12 422 (28%) | 438/7107 (6%) | 963/9069 (11%) | 1370/5269 (26%) | 2815/2855 (99%) |
| Clinic | 5142/18 175 (28%) | 2592/10 079 (26%) | 2796/12 422 (23%) | 3147/7107 (44%) | 2291/9069 (25%) | 131/5269 (2%) | 6/2855 (<1%) |
| Home or other | 1485/18 175 (8%) | 1022/10 079 (10%) | 6204/12 422 (50%) | 3522/7107 (50%) | 5815/9069 (64%) | 3768/5269 (72%) | 34/2855 (1%) |
| Antenatal care (n/N [%]) | 18 162/18 196 (100%) | 10 076/10 078 (100%) | 9917/12 402 (80%) | 7030/7108 (99%) | 8551/9069 (94%) | 5149/5269 (98%) | 2659/2837 (94%) |
| Identification (signs of preterm birth) | |||||||
| Location | Community, clinic, hospital | Community, clinic, hospital | Community, clinic, hospital | Community, clinic, hospital | Community, clinic, hospital | Community, clinic, hospital | Clinic, hospital |
| Provider | CHW, nurse, physician | Self-identification, nurse, physician | Self-identification, TBA, CHW, nurse, physician | TBA, nurse, physician | CHW, nurse | Self-identification, TBA, nurse, physician | Nurse, physician |
| Identification (gestational age assessment) | |||||||
| Location | Community, clinic, hospital | Community, clinic, hospital | Community, clinic, hospital | Community, clinic, hospital | Community, clinic, hospital | Community, clinic, hospital | Clinic, hospital |
| Provider | CHW, nurse, physician | TBA, CHW, nurse, physician | TBA, nurse, physician | TBA, nurse, physician | Nurse | TBA, nurse, physician, | Nurse, physician |
| Antenatal corticosteroid administration* | |||||||
| Location | Community, clinic, hospital | Clinic, hospital | Community, clinic, hospital | Clinic, hospital | Community, clinic, hospital | Community, clinic, hospital | Clinic, hospital |
| Provider | Nurse, physician | Nurse, physician | CHW, nurse, physician | Nurse, physician | Nurse | Nurse | Nurse, physician |
| Steroid type† | |||||||
| Name (manufacturer) | Dexona (Zydus Cadila) | Decamycin (Ranbaxy) and Decacin (Natco) | Decadron (OBS Pakistan) | Dexona (Zydus Cadila) | Dexamethasone (Dawa) | Dexamethasone (Caplin Point Laboratories) | Trofinan (Biol) |
| Description | 8 mg per 2 mL vial | 4 mg per 1 mL vial | 4 mg per 1 mL vial | 8 mg per 2 mL vial | 4 mg per 1 mL ampoule | 8 mg per 2 mL ampoule | 8 mg per 2 mL ampoule |
| Trial period | April 10, 2012–Oct 10, 2013, and May 1, 2012–Oct 31, 2013 | June 11, 2012–Dec 11, 2013 | June 5, 2012–Dec 5, 2013 | April 14, 2012–Oct 14, 2013 | April 30, 2012–Oct 30, 2013 | Sept 20, 2012–March 20, 2014 | Oct 1, 2011–March 31, 2013 |
Data for location of birth and antenatal care are from before the trial (2010). Nurses includes auxiliary nurses, nurses, nurse midwives, and similar. TBA=traditional birth attendant. CHW=community health workers (term encompasses a range of health workers specific to countries).
*
Community-level administration by study staff or nurse (Guatemala); auxiliary nurse midwife (Belgaum, India); vaccinators (Pakistan); and study nurses or clinical officers (Kenya).
†
All sites used dexamethasone sodium phosphate injection.