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The effects of vitamin C supplementation on pre-eclampsia in Mulago Hospital, Kampala, Uganda: a randomized placebo controlled clinical trial.

Kiondo P, Wamuyu-Maina G, Wandabwa J, Bimenya GS, Tumwesigye NM, Okong P - BMC Pregnancy Childbirth (2014)

Bottom Line: The primary outcome was pre-eclamsia.Secondary outcomes were: severe pre-eclampsia, gestational hypertension, preterm delivery, low birth weight and still birth delivery.Supplementation with vitamin C did not reduce the incidence of pre-eclampsia nor did it reduce the adverse maternal or neonatal outcomes.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynaecology, School of Medicine, Makerere University College of Health Sciences, P,O Box 7072, Kampala, Uganda. kiondop@yahoo.com.

ABSTRACT

Background: Oxidative stress plays a role in the pathogenesis of pre-eclampsia. Supplementing women with antioxidants during pregnancy may reduce oxidative stress and thereby prevent or delay the onset pre-eclampsia. The objective of this study was to evaluate the effect of supplementing vitamin C in pregnancy on the incidence of pre-eclampsia, at Mulago hospital, Kampala, Uganda.

Methods: This was a (parallel, balanced randomization, 1:1) placebo randomized controlled trial conducted at Mulago hospital, Department of Obstetrics and Gynecology. Participants included in this study were pregnant women aged 15-42 years, who lived 15 km or less from the hospital with gestational ages between 12-22 weeks. The women were randomized to take 1000mg of vitamin C (as ascorbic acid) or a placebo daily until they delivered. The primary outcome was pre-eclamsia. Secondary outcomes were: severe pre-eclampsia, gestational hypertension, preterm delivery, low birth weight and still birth delivery. Participants were 932 pregnant women randomized into one of the two treatment arms in a ratio of 1:1. The participants, the care providers and those assessing the outcomes were blinded to the study allocation.

Results: Of the 932 women recruited; 466 were randomized to the vitamin and 466 to the placebo group. Recruitment of participants was from November 2011 to June 2012 and follow up was up to January 2013. Outcome data was available 415 women in the vitamin group and 418 women in the placebo group.There were no differences in vitamin and placebo groups in the incidence of pre-eclampsia (3.1% versus 4.1%; RR 0.77; 95% CI: 0.37-1.56), severe pre-eclampsia (1.2% versus 1.0%; RR 1.25; 95% CI: 0.34-4.65), gestational hypertension(7.7% versus 11.5%; RR 0.67; 95% CI: 0.43-1.03), preterm delivery (11.3% versus 12.2%; RR 0.92; 95% CI: 0.63-1.34), low birth weight (11.1% versus 10.3%; RR 1.07; 95% CI: 0.72-1.59) and still birth delivery (4.6% versus 4.5%; RR 1.01; 95% CI: 0.54-1.87).

Conclusions: Supplementation with vitamin C did not reduce the incidence of pre-eclampsia nor did it reduce the adverse maternal or neonatal outcomes. We do not recommend the use of vitamin C in pregnancy to prevent pre-eclampsia.

Trial registration: This study was registered at the Pan African Clinical Trial Registry, PACTR201210000418271 on 25th October 2012.

No MeSH data available.


Related in: MedlinePlus

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Fig1: Trial profile.

Mentions: We screened 1,097 women, of which 956 were eligible but 932 women were willing to participate in the study and were randomized (466(50%) to the vitamin C group and 466(50%) to the placebo group). The losses to follow-up were 51(10.9%) women in the vitamin group and 48(10.3%) women in the placebo group (FigureĀ 1). Recruitment started in November 2011 and was completed in June 2012.Figure 1


The effects of vitamin C supplementation on pre-eclampsia in Mulago Hospital, Kampala, Uganda: a randomized placebo controlled clinical trial.

Kiondo P, Wamuyu-Maina G, Wandabwa J, Bimenya GS, Tumwesigye NM, Okong P - BMC Pregnancy Childbirth (2014)

Trial profile.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4150937&req=5

Fig1: Trial profile.
Mentions: We screened 1,097 women, of which 956 were eligible but 932 women were willing to participate in the study and were randomized (466(50%) to the vitamin C group and 466(50%) to the placebo group). The losses to follow-up were 51(10.9%) women in the vitamin group and 48(10.3%) women in the placebo group (FigureĀ 1). Recruitment started in November 2011 and was completed in June 2012.Figure 1

Bottom Line: The primary outcome was pre-eclamsia.Secondary outcomes were: severe pre-eclampsia, gestational hypertension, preterm delivery, low birth weight and still birth delivery.Supplementation with vitamin C did not reduce the incidence of pre-eclampsia nor did it reduce the adverse maternal or neonatal outcomes.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynaecology, School of Medicine, Makerere University College of Health Sciences, P,O Box 7072, Kampala, Uganda. kiondop@yahoo.com.

ABSTRACT

Background: Oxidative stress plays a role in the pathogenesis of pre-eclampsia. Supplementing women with antioxidants during pregnancy may reduce oxidative stress and thereby prevent or delay the onset pre-eclampsia. The objective of this study was to evaluate the effect of supplementing vitamin C in pregnancy on the incidence of pre-eclampsia, at Mulago hospital, Kampala, Uganda.

Methods: This was a (parallel, balanced randomization, 1:1) placebo randomized controlled trial conducted at Mulago hospital, Department of Obstetrics and Gynecology. Participants included in this study were pregnant women aged 15-42 years, who lived 15 km or less from the hospital with gestational ages between 12-22 weeks. The women were randomized to take 1000mg of vitamin C (as ascorbic acid) or a placebo daily until they delivered. The primary outcome was pre-eclamsia. Secondary outcomes were: severe pre-eclampsia, gestational hypertension, preterm delivery, low birth weight and still birth delivery. Participants were 932 pregnant women randomized into one of the two treatment arms in a ratio of 1:1. The participants, the care providers and those assessing the outcomes were blinded to the study allocation.

Results: Of the 932 women recruited; 466 were randomized to the vitamin and 466 to the placebo group. Recruitment of participants was from November 2011 to June 2012 and follow up was up to January 2013. Outcome data was available 415 women in the vitamin group and 418 women in the placebo group.There were no differences in vitamin and placebo groups in the incidence of pre-eclampsia (3.1% versus 4.1%; RR 0.77; 95% CI: 0.37-1.56), severe pre-eclampsia (1.2% versus 1.0%; RR 1.25; 95% CI: 0.34-4.65), gestational hypertension(7.7% versus 11.5%; RR 0.67; 95% CI: 0.43-1.03), preterm delivery (11.3% versus 12.2%; RR 0.92; 95% CI: 0.63-1.34), low birth weight (11.1% versus 10.3%; RR 1.07; 95% CI: 0.72-1.59) and still birth delivery (4.6% versus 4.5%; RR 1.01; 95% CI: 0.54-1.87).

Conclusions: Supplementation with vitamin C did not reduce the incidence of pre-eclampsia nor did it reduce the adverse maternal or neonatal outcomes. We do not recommend the use of vitamin C in pregnancy to prevent pre-eclampsia.

Trial registration: This study was registered at the Pan African Clinical Trial Registry, PACTR201210000418271 on 25th October 2012.

No MeSH data available.


Related in: MedlinePlus