L‐Jaramillo 1990.
Methods | Randomised, double‐blind trial. Stated "Each patient was assigned independently in sequence", and "All women completed the study". | |
Participants | Women attending a hospital in Quito, Ecuador. Dates of recruitment not stated. Healthy nulliparous women with positive roll‐over test at 28‐30 weeks' gestational age ‐ judged at high risk for gestational hypertension. | |
Interventions | 2000 mg elemental calcium daily, from 28‐32 weeks to delivery, vs placebo starch tablets. | |
Outcomes | Gestational hypertension (BP > 140/90 mmHg on 2 occasions 6 hours apart); proteinuria (300 mg/L); duration of pregnancy (calcium mean 39.2 (SD 1.2) vs placebo 37.4 (2.3) weeks); birthweight (2936 (396) vs 2685 (427) g). | |
Notes | Quito, Ecuador (altitude 2800 m). 22 in calcium group, 34 in placebo group. Source of funding: not stated. CoI: not stated. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Authors state that this was a RCT but no details of sequence generation are provided. |
Allocation concealment (selection bias) | Unclear risk | No details given about how concealment was achieved or whether tablets looked identical |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Stated double‐blind but no further information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Stated double‐blind but no further information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not clear |
Selective reporting (reporting bias) | Unclear risk | Not clear |
Other bias | Unclear risk | Large discrepancy in size of groups not accounted for |