Antioxidants for preventing pre‐eclampsia

Alice Rumbold; Lelia Duley; Caroline A Crowther; Ross RR Haslam

doi:10.1002/14651858.CD004227.pub2

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Analysis 1.1

Comparison 1 Any antioxidants versus control or placebo, Outcome 1 Pre‐eclampsia (subgroups by whether random or quasi‐random allocation).

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Analysis 1.2

Comparison 1 Any antioxidants versus control or placebo, Outcome 2 Preterm birth (< 37 weeks).

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Analysis 1.3

Comparison 1 Any antioxidants versus control or placebo, Outcome 3 Small‐for‐gestational age.

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Analysis 1.4

Comparison 1 Any antioxidants versus control or placebo, Outcome 4 Stillbirth.

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Analysis 1.5

Comparison 1 Any antioxidants versus control or placebo, Outcome 5 Neonatal death.

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Analysis 1.6

Comparison 1 Any antioxidants versus control or placebo, Outcome 6 Elective delivery (induction of labour or elective caesarean section).

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Analysis 1.7

Comparison 1 Any antioxidants versus control or placebo, Outcome 7 Bleeding episodes (including placental abruption, APH, PPH, need for transfusion).

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Analysis 1.8

Comparison 1 Any antioxidants versus control or placebo, Outcome 8 Serious maternal morbidity (including eclampsia, liver and renal failure, DIC, stroke).

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Analysis 1.9

Comparison 1 Any antioxidants versus control or placebo, Outcome 9 Gestational age at birth.

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Analysis 1.10

Comparison 1 Any antioxidants versus control or placebo, Outcome 10 Birthweight.

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Analysis 1.11

Comparison 1 Any antioxidants versus control or placebo, Outcome 11 Length of stay in hospital‐neonatal.

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Analysis 2.1

Comparison 2 Any antioxidants versus control or placebo (sensitivity analyses based on trial quality), Outcome 1 Pre‐eclampsia.

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Analysis 2.2

Comparison 2 Any antioxidants versus control or placebo (sensitivity analyses based on trial quality), Outcome 2 Preterm birth (< 37 weeks).

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Analysis 2.3

Comparison 2 Any antioxidants versus control or placebo (sensitivity analyses based on trial quality), Outcome 3 Small‐for‐gestational age.

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Analysis 2.4

Comparison 2 Any antioxidants versus control or placebo (sensitivity analyses based on trial quality), Outcome 4 Stillbirth.

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Analysis 2.5

Comparison 2 Any antioxidants versus control or placebo (sensitivity analyses based on trial quality), Outcome 5 Neonatal death.

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Analysis 3.1

Comparison 3 Any antioxidants versus control or placebo (subgroups by risk status), Outcome 1 Pre‐eclampsia.

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Analysis 3.2

Comparison 3 Any antioxidants versus control or placebo (subgroups by risk status), Outcome 2 Preterm birth.

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Analysis 3.3

Comparison 3 Any antioxidants versus control or placebo (subgroups by risk status), Outcome 3 Small‐for‐gestational‐age infant.

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Analysis 3.4

Comparison 3 Any antioxidants versus control or placebo (subgroups by risk status), Outcome 4 Stillbirth.

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Analysis 3.5

Comparison 3 Any antioxidants versus control or placebo (subgroups by risk status), Outcome 5 Neonatal death.

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Analysis 4.1

Comparison 4 Any antioxidants versus control or placebo (subgroups by gestation at entry), Outcome 1 Pre‐eclampsia.

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Analysis 4.2

Comparison 4 Any antioxidants versus control or placebo (subgroups by gestation at entry), Outcome 2 Preterm birth.

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Analysis 4.3

Comparison 4 Any antioxidants versus control or placebo (subgroups by gestation at entry), Outcome 3 Small‐for‐gestational age.

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Analysis 4.4

Comparison 4 Any antioxidants versus control or placebo (subgroups by gestation at entry), Outcome 4 Stillbirth.

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Analysis 4.5

Comparison 4 Any antioxidants versus control or placebo (subgroups by gestation at entry), Outcome 5 Neonatal death.

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Analysis 5.1

Comparison 5 Any antioxidants versus control or placebo (subgroups according to dose), Outcome 1 Pre‐eclampsia.

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Analysis 5.2

Comparison 5 Any antioxidants versus control or placebo (subgroups according to dose), Outcome 2 Stillbirth.

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Analysis 5.3

Comparison 5 Any antioxidants versus control or placebo (subgroups according to dose), Outcome 3 Neonatal death.

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Analysis 6.1

Comparison 6 Any antioxidants versus control or placebo (subgroups by use of antioxidants combined with other agents), Outcome 1 Pre‐eclampsia.

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Analysis 6.2

Comparison 6 Any antioxidants versus control or placebo (subgroups by use of antioxidants combined with other agents), Outcome 2 Preterm birth (< 37 weeks).

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Analysis 6.3

Comparison 6 Any antioxidants versus control or placebo (subgroups by use of antioxidants combined with other agents), Outcome 3 Small‐for‐gestational age.

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Analysis 6.4

Comparison 6 Any antioxidants versus control or placebo (subgroups by use of antioxidants combined with other agents), Outcome 4 Stillbirth.

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Analysis 6.5

Comparison 6 Any antioxidants versus control or placebo (subgroups by use of antioxidants combined with other agents), Outcome 5 Neonatal death.

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Analysis 7.1

Comparison 7 Any antioxidants versus control or placebo (subgroups according to dietary intake at entry), Outcome 1 Pre‐eclampsia.

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Analysis 7.2

Comparison 7 Any antioxidants versus control or placebo (subgroups according to dietary intake at entry), Outcome 2 Stillbirth.

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Analysis 7.3

Comparison 7 Any antioxidants versus control or placebo (subgroups according to dietary intake at entry), Outcome 3 Neonatal death.

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Table 1. Any antioxidants ‐ hypertension (undefined)

Antioxidants n/N	Control n/N	RR	95% CI
11/100	7/100	1.57	0.63 to 3.89

Table 1. Any antioxidants ‐ hypertension (undefined)

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Comparison 1. Any antioxidants versus control or placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pre‐eclampsia (subgroups by whether random or quasi‐random allocation) Show forest plot	7	6082	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.50, 0.75]

1.1 Studies with random allocation	6	1061	Risk Ratio (M‐H, Fixed, 95% CI)	0.45 [0.31, 0.66]
1.2 Studies with quasi‐random allocation	1	5021	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.55, 0.90]
2 Preterm birth (< 37 weeks) Show forest plot	3	583	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.04, 1.82]

2.1 Studies with random allocation	3	583	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.04, 1.82]
2.2 Studies with quasi‐random allocation	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Small‐for‐gestational age Show forest plot	3	634	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.47, 0.87]

3.1 Studies with random allocation	3	634	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.47, 0.87]
3.2 Studies with quasi‐random studies	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Stillbirth Show forest plot	3	5504	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.59, 1.17]

4.1 Studies with random allocation	2	483	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.18, 5.76]
4.2 Quasi‐random studies only	1	5021	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.58, 1.17]
5 Neonatal death Show forest plot	2	5076	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.81, 2.19]

5.1 Studies with random allocation	1	181	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.12, 4.03]
5.2 Studies with quasi‐random allocation (death before 8 days)	1	4895	Risk Ratio (M‐H, Fixed, 95% CI)	1.41 [0.84, 2.37]
6 Elective delivery (induction of labour or elective caesarean section) Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.51, 7.78]

6.1 Induction of labour	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.51, 7.78]
7 Bleeding episodes (including placental abruption, APH, PPH, need for transfusion) Show forest plot	2	483	Risk Ratio (M‐H, Random, 95% CI)	1.58 [0.08, 31.47]

7.1 Studies with random allocation	2	483	Risk Ratio (M‐H, Random, 95% CI)	1.58 [0.08, 31.47]
7.2 Studies with quasi‐random allocation	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
8 Serious maternal morbidity (including eclampsia, liver and renal failure, DIC, stroke) Show forest plot	1	251	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.02, 9.42]

8.1 Eclampsia (studies with random allocation)	1	251	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.02, 9.42]
8.2 Eclampsia (studies with quasi‐random allocation)	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Gestational age at birth Show forest plot	2	351	Mean Difference (IV, Fixed, 95% CI)	1.01 [0.56, 1.46]

9.1 Studies with random allocation	2	351	Mean Difference (IV, Fixed, 95% CI)	1.01 [0.56, 1.46]
9.2 Studies with quasi‐random allocation	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10 Birthweight Show forest plot	3	451	Mean Difference (IV, Fixed, 95% CI)	91.83 [11.55, 172.11]

10.1 Studies with random allocation	3	451	Mean Difference (IV, Fixed, 95% CI)	91.83 [11.55, 172.11]
10.2 Studies with quasi‐random allocation	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
11 Length of stay in hospital‐neonatal Show forest plot	1	181	Mean Difference (IV, Fixed, 95% CI)	1.30 [‐0.28, 2.88]

11.1 Studies with random allocation	1	181	Mean Difference (IV, Fixed, 95% CI)	1.30 [‐0.28, 2.88]
11.2 Studies with quasi‐random allocation	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Any antioxidants versus control or placebo

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Comparison 2. Any antioxidants versus control or placebo (sensitivity analyses based on trial quality)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pre‐eclampsia Show forest plot	3	734	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.32, 0.80]

1.1 High‐quality studies (Allocation concealment = A, blinding, < 3% exclusions and use of placebo)	3	734	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.32, 0.80]
2 Preterm birth (< 37 weeks) Show forest plot	2	483	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.02, 1.93]

2.1 High‐quality studies (Allocation concealment = A, blinding, < 3% exclusions and use of placebo)	2	483	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.02, 1.93]
3 Small‐for‐gestational age Show forest plot	2	534	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.47, 0.89]

3.1 High‐quality studies (Allocation concealment = A, blinding, < 3% exclusions and use of placebo)	2	534	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.47, 0.89]
4 Stillbirth Show forest plot	2	483	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.18, 5.76]

4.1 High‐quality studies (Allocation concealment = A, blinding, < 3% exclusions and use of placebo)	2	483	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.18, 5.76]
5 Neonatal death Show forest plot	1	181	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.12, 4.03]

5.1 High‐quality studies (Allocation concealment = A, blinding, < 3% exclusions and use of placebo)	1	181	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.12, 4.03]

Comparison 2. Any antioxidants versus control or placebo (sensitivity analyses based on trial quality)

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Comparison 3. Any antioxidants versus control or placebo (subgroups by risk status)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pre‐eclampsia Show forest plot	7	6082	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.50, 0.75]

1.1 Moderate/low‐risk women	4	5572	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.53, 0.83]
1.2 Moderate/high‐risk women	3	510	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.27, 0.71]
2 Preterm birth Show forest plot	3	583	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.04, 1.82]

2.1 Moderate/low‐risk women	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [1.03, 1.99]
2.2 Moderate/high‐risk women	2	383	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.78, 2.15]
3 Small‐for‐gestational‐age infant Show forest plot	3	634	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.47, 0.87]

3.1 Moderate/low‐risk women	1	251	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.29, 0.91]
3.2 Moderate/high‐risk women	2	383	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.49, 1.04]
4 Stillbirth Show forest plot	3	5504	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.59, 1.17]

4.1 Moderate/low‐risk women	2	5221	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.60, 1.19]
4.2 Moderate/high‐risk women	1	283	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.05, 5.49]
5 Neonatal death Show forest plot	2	5076	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.81, 2.19]

5.1 Moderate/low‐risk women	2	5076	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.81, 2.19]
5.2 Moderate/high‐risk women	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 3. Any antioxidants versus control or placebo (subgroups by risk status)

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Comparison 4. Any antioxidants versus control or placebo (subgroups by gestation at entry)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pre‐eclampsia Show forest plot	7	6082	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.50, 0.75]

1.1 Entered into study < 20 weeks	2	351	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.36, 1.04]
1.2 Entered into study >= 20 weeks	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.10 [0.01, 1.86]
1.3 Entered into study both < and >= 20 weeks	4	5631	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.50, 0.79]
2 Preterm birth Show forest plot	3	583	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.04, 1.82]

2.1 Entered into study < 20 weeks	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [0.75, 2.31]
2.2 Entered into study >= 20 weeks	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 Entered into study both < and >= 20 weeks	2	483	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.02, 1.93]
3 Small‐for‐gestational age Show forest plot	3	634	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.47, 0.87]

3.1 Entered into study < 20 weeks	2	351	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.29, 0.87]
3.2 Entered into study >= 20 weeks	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 Entered into study both < and >= 20 weeks	1	283	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.50, 1.08]
4 Stillbirth Show forest plot	3	5504	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.59, 1.17]

4.1 Entered into study < 20 weeks	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Entered into study >= 20 weeks	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.3 Entered into study both < and >= 20 weeks	3	5504	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.59, 1.17]
5 Neonatal death Show forest plot	2	5076	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.81, 2.19]

5.1 Entered into study < 20 weeks	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 Entered into study >= 20 weeks	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.3 Entered into study both < and >= 20 weeks	2	5076	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.81, 2.19]

Comparison 4. Any antioxidants versus control or placebo (subgroups by gestation at entry)

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Comparison 5. Any antioxidants versus control or placebo (subgroups according to dose)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pre‐eclampsia Show forest plot	7	6082	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.50, 0.75]

1.1 High dose (within pharmacological range)	4	710	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.30, 0.75]
1.2 Low dose (below pharmacological range)	1	5021	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.55, 0.90]
1.3 Unspecified	2	351	Risk Ratio (M‐H, Fixed, 95% CI)	0.42 [0.21, 0.81]
2 Stillbirth Show forest plot	3	5504	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.59, 1.17]

2.1 High dose (within pharmacological range)	2	483	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.18, 5.76]
2.2 Low dose (below pharmacological range)	1	5021	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.58, 1.17]
2.3 Unspecified	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Neonatal death Show forest plot	2	5076	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.81, 2.19]

3.1 High dose (within pharmacological range)	1	181	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.12, 4.03]
3.2 Low dose (below pharmacological range)	1	4895	Risk Ratio (M‐H, Fixed, 95% CI)	1.41 [0.84, 2.37]
3.3 Unspecified	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 5. Any antioxidants versus control or placebo (subgroups according to dose)

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Comparison 6. Any antioxidants versus control or placebo (subgroups by use of antioxidants combined with other agents)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pre‐eclampsia Show forest plot	7	6082	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.50, 0.75]

1.1 Antioxidants alone	5	934	Risk Ratio (M‐H, Fixed, 95% CI)	0.54 [0.36, 0.80]
1.2 Antioxidants with other agents	2	5148	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.50, 0.82]
2 Preterm birth (< 37 weeks) Show forest plot	3	583	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.04, 1.82]

2.1 Antioxidants alone	3	583	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.04, 1.82]
2.2 Antioxidants with other agents	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Small‐for‐gestational age Show forest plot	3	634	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.47, 0.87]

3.1 Antioxidants alone	3	634	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.47, 0.87]
3.2 Antioxidants with other agents	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Stillbirth Show forest plot	3	5504	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.59, 1.17]

4.1 Antioxidants alone	2	483	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.18, 5.76]
4.2 Antioxidants with other agents	1	5021	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.58, 1.17]
5 Neonatal death Show forest plot	2	5076	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.81, 2.19]

5.1 Antioxidants alone	1	181	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.12, 4.03]
5.2 Antioxidants with other agents	1	4895	Risk Ratio (M‐H, Fixed, 95% CI)	1.41 [0.84, 2.37]

Comparison 6. Any antioxidants versus control or placebo (subgroups by use of antioxidants combined with other agents)

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Comparison 7. Any antioxidants versus control or placebo (subgroups according to dietary intake at entry)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pre‐eclampsia Show forest plot	7	6082	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.50, 0.75]

1.1 Deficient dietary intake at trial entry	1	5021	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.55, 0.90]
1.2 Unknown dietary intake at trial entry	6	1061	Risk Ratio (M‐H, Fixed, 95% CI)	0.45 [0.31, 0.66]
2 Stillbirth Show forest plot	3	5504	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.59, 1.17]

2.1 Deficient dietary intake at trial entry	1	5021	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.58, 1.17]
2.2 Unknown dietary intake at trial entry	2	483	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.18, 5.76]
3 Neonatal death Show forest plot	2	5076	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.81, 2.19]

3.1 Deficient dietary intake at trial entry	1	4895	Risk Ratio (M‐H, Fixed, 95% CI)	1.41 [0.84, 2.37]
3.2 Unknown dietary intake at trial entry	1	181	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.12, 4.03]

Comparison 7. Any antioxidants versus control or placebo (subgroups according to dietary intake at entry)

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