L‐Jaramillo 1997.
Methods | Prospective, randomised, double‐blind, placebo‐controlled trial. | |
Participants | Hospital setting in Quito Ecuador, women recruited 1990‐1995. Inclusion criteria: age < 17.5 years; nulliparous; first prenatal visit before 20 weeks' gestation; certain menstrual dates; residency in Quito for at least 1 year; BP =/< 120/80 mmHg; no underlying medical disorders; no drug, mineral or vitamin therapy. Average daily calcium intake in this population is 51% of the recommended dietary allowance. |
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Interventions | Elemental calcium 2 g daily as calcium carbonate from 20 weeks (n = 134), vs placebo tablets (n = 140). | |
Outcomes | Pre‐eclampsia (BP > 140/90 mmHg on 2 occasions > 6 hours apart, and proteinuria > 300 mg/L (> 1+ on dipstick on 2 occasions 4‐24 hours apart)). BP recorded as mean of 2 measurements, 2 minutes apart, in the right arm, in the sitting position (1st and 5th Korotkoff sounds). Maternal serum ionised calcium at 38 weeks was calcium group mean 1.23, SD 0.02 mM vs placebo 1.16, 0.02; umbilical cord serum ionised calcium levels were calcium 1.44, 0.04 vs placebo 1,37, 0.03; gestational length was calcium 39.6, 0.4 vs placebo 38.7, 0.3. |
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Notes | Quito, Ecuador (altitude 2800 m). 1990 to 1995. Source of funding: supported by the Safe Motherhood Program, World Health Organization. CoI: not stated. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table used to assign each participant independently in sequence to calcium or placebo regimen |
Allocation concealment (selection bias) | Low risk | Adequate. Tablets similar in weight, colour, size. Containers and tablets prepared by the Department of Chemistry and Pharmacy, Central University of Ecuador |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 274 recruited, 260 analysed |
Selective reporting (reporting bias) | Unclear risk | Only participants with no missing values were included in the analyses (125 in calcium group and 135 in placebo group). |
Other bias | Unclear risk | 14 withdrawals after randomisation: 12 by change to another hospital or private medical doctor, 2 by non‐compliance. 9/134 (6.7%) were from the calcium group and 5/140 (3.6%) from the placebo group. |