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Meta-Analysis
. 2014 May 8;2014(5):CD002860.
doi: 10.1002/14651858.CD002860.pub2.

Nitric oxide donors for treating preterm labour

Kirsten Duckitt  1 , Steve Thornton, Oliver P O'Donovan, Therese Dowswell
Affiliations
Meta-Analysis

Nitric oxide donors for treating preterm labour

Kirsten Duckitt et al. Cochrane Database Syst Rev. .

Abstract

Background: A number of tocolytics have been advocated for the treatment of threatened preterm labour in order to delay birth. The rationale is that a delay in birth may be associated with improved neonatal morbidity or mortality. Nitric oxide donors, such as nitroglycerin, have been used to relax the uterus. This review addresses their efficacy, adverse effects and influence on neonatal outcome.

Objectives: To determine whether nitric oxide donors administered in threatened preterm labour are associated with a delay in birth, adverse effects or improved neonatal outcome.

Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 December 2013).

Selection criteria: Randomised controlled trials of nitric oxide donors administered for tocolysis.

Data collection and analysis: Two review authors independently assessed trial quality and extracted data.

Main results: Twelve trials, including a total of 1227 women at risk of preterm labour, contributed data to this updated review. The methodological quality of trials was mixed; trials comparing nitric oxide donors with other types of tocolytics were not blinded and this may have had an impact on findings.Three studies compared nitric oxide donors (glyceryl trinitrate (GTN)) with placebo. There was no significant evidence that nitric oxide donors prolonged pregnancy beyond 48 hours (average risk ratio (RR) 1.19, 95% confidence interval (CI) 0.74 to 1.90, two studies, 186 women), and although for most adverse effects there was no significant difference between groups, women in the active treatment group in one study were at higher risk of experiencing a headache. For infant outcomes there was no significant evidence that nitric oxide donors reduced the risk of neonatal death or serious morbidity (stillbirth RR 0.36, 95% CI 0.01 to 8.59, one study, 153 infants; neonatal death RR 0.43, 95% CI 0.06 to 2.89, two studies, 186 infants). One study, using a composite outcome, reported a reduced risk of serious adverse outcomes for infants in the GTN group which approached statistical significance (RR 0.29, 95% CI 0.08 to 1.00, 153 infants). Overall, these studies were underpowered to identify differences between groups for most outcomes.When nitric oxide donors were compared with other tocolytic drugs there was no significant evidence that nitric oxide donors performed better than other tocolytics (betamimetics, magnesium sulphate, a calcium channel blocker or a combination of tocolytics) in terms of pregnancy prolongation, although nitric oxide donors appeared to be associated with a reduction in most adverse effects, apart from headache. There was no significant difference between groups for infant morbidity or mortality outcomes.

Authors' conclusions: There is currently insufficient evidence to support the routine administration of nitric oxide donors in the treatment of threatened preterm labour.

PubMed Disclaimer

Conflict of interest statement

ST provides commercial consultancy advice. None of these companies make any of the drugs included in the review. KD has received honoraria from Merck, Bayer and Actavis. None of these companies produce tocolytics. TD has been paid from a grant from WHO for work on this review; WHO has had no influence over the findings or conclusions of the review.

Figures

1
1
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 1 Prolongation of pregnancy greater than 48 hours.
1.2
1.2. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 2 Birth prior to 37 completed weeks.
1.3
1.3. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 3 Birth prior to 34 completed weeks.
1.4
1.4. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 4 Birth prior to 28 completed weeks.
1.5
1.5. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 5 Caesarean section.
1.6
1.6. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 6 Any adverse drug reactions.
1.7
1.7. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 7 Headache.
1.8
1.8. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 8 Dizziness.
1.9
1.9. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 9 Flushing.
1.10
1.10. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 10 Hypotension.
1.11
1.11. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 11 Completion of course of maternal steroids.
1.12
1.12. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 12 Death unrelated to congenital abnormalities.
1.13
1.13. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 13 Intraventricular haemorrhage.
1.14
1.14. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 14 Respiratory distress syndrome.
1.15
1.15. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 15 Chronic lung disease.
1.16
1.16. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 16 Birthweight (grams).
1.17
1.17. Analysis
Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 17 (Non‐prespecified) Composite outcome: serious infant morbidity or mortality.
2.1
2.1. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 1 Prolongation of pregnancy greater than 24 hours.
2.2
2.2. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 2 Prolongation of pregnancy greater than 48 hours.
2.3
2.3. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 3 Prolongation of pregnancy greater than 7 days.
2.4
2.4. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 4 Prolongation of pregnancy greater than 14 days.
2.5
2.5. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 5 Birth prior to 37 completed weeks.
2.6
2.6. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 6 Birth prior to 34 completed weeks.
2.7
2.7. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 7 Birth prior to 32 completed weeks.
2.8
2.8. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 8 Caesarean section.
2.9
2.9. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 9 Adverse effects.
2.10
2.10. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 10 Headache.
2.11
2.11. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 11 Dizziness.
2.12
2.12. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 12 Palpitations.
2.13
2.13. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 13 Shortness of breath.
2.14
2.14. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 14 Nausea.
2.15
2.15. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 15 Tachycardia.
2.16
2.16. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 16 Chest pain/tightness.
2.17
2.17. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 17 Adverse effects leading to treatment cessations.
2.18
2.18. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 18 Maternal pulmonary oedema.
2.19
2.19. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 19 Death unrelated to congenital abnormalities.
2.20
2.20. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 20 Use of mechanical ventilation.
2.21
2.21. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 21 Chronic lung disease.
2.22
2.22. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 22 Admission of infant to neonatal intensive care unit.
2.23
2.23. Analysis
Comparison 2 Nitric oxide donors versus any betamimetic, Outcome 23 Birthweight.
3.1
3.1. Analysis
Comparison 3 Nitric oxide donors versus magnesium sulphate, Outcome 1 Headache.
3.2
3.2. Analysis
Comparison 3 Nitric oxide donors versus magnesium sulphate, Outcome 2 Dizziness.
3.3
3.3. Analysis
Comparison 3 Nitric oxide donors versus magnesium sulphate, Outcome 3 Flushing.
3.4
3.4. Analysis
Comparison 3 Nitric oxide donors versus magnesium sulphate, Outcome 4 Palpitations.
3.5
3.5. Analysis
Comparison 3 Nitric oxide donors versus magnesium sulphate, Outcome 5 Hypotension.
4.1
4.1. Analysis
Comparison 4 Nitric oxide donors versus any calcium channel blocker, Outcome 1 Prolongation of pregnancy greater than 48 hours.
4.2
4.2. Analysis
Comparison 4 Nitric oxide donors versus any calcium channel blocker, Outcome 2 Headache.
4.3
4.3. Analysis
Comparison 4 Nitric oxide donors versus any calcium channel blocker, Outcome 3 Flushing.
4.4
4.4. Analysis
Comparison 4 Nitric oxide donors versus any calcium channel blocker, Outcome 4 Hypotension.
4.5
4.5. Analysis
Comparison 4 Nitric oxide donors versus any calcium channel blocker, Outcome 5 Nausea.
4.6
4.6. Analysis
Comparison 4 Nitric oxide donors versus any calcium channel blocker, Outcome 6 Tachycardia.
5.1
5.1. Analysis
Comparison 5 Nitric oxide donors versus combination of tocolytics, Outcome 1 Prolongation of pregnancy greater than 48 hours.
5.2
5.2. Analysis
Comparison 5 Nitric oxide donors versus combination of tocolytics, Outcome 2 Caesarean section.
5.3
5.3. Analysis
Comparison 5 Nitric oxide donors versus combination of tocolytics, Outcome 3 Headache.
5.4
5.4. Analysis
Comparison 5 Nitric oxide donors versus combination of tocolytics, Outcome 4 Flushing.
5.5
5.5. Analysis
Comparison 5 Nitric oxide donors versus combination of tocolytics, Outcome 5 Nausea.
5.6
5.6. Analysis
Comparison 5 Nitric oxide donors versus combination of tocolytics, Outcome 6 Tachycardia.
5.7
5.7. Analysis
Comparison 5 Nitric oxide donors versus combination of tocolytics, Outcome 7 Chest pain/tightness.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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