Archives of gynecology and obstetrics · 2018
The effect of alpha lipoic acid on uterine wound healing after primary cesarean section: a triple-blind placebo-controlled parallel-group randomized clinical trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Sammour Hazem, Elkholy Abdellatif, Rasheedy Radwa, Fadel Ebtesam
Аннотация
PURPOSE: To investigate the effect of alpha lipoic acid (ALA) on uterine wound healing after primary cesarean section (CS).
METHODS: A parallel-group, triple-blind, placebo-controlled randomized clinical trial was conducted in Ain Shams University Maternity Hospital, Cairo, Egypt, involving 102 women undergoing pre-labor primary CS. The participants were randomly assigned using a computer-generated list of random numbers to receive oral ALA or a placebo twice daily for 6 weeks after CS. Allocation to either group was in a 1:1 ratio by an independent statistician (not involved in the treatment or data collection). The primary outcome was the presence of CS defect and measuring its depth and width. Secondary outcomes were measurements of the anterior myometrial and residual myometrium thicknesses, healing ratio and the presence of intrauterine adhesions. Assessment was done using saline contrast sonohysterography.
RESULTS: Twenty (39.2%) women in the treatment group and ten (19.6%) controls had no niche (P value = 0.03, 95% CI - 0.388, - 0.0037). The absolute and relative risk reduction of forming a niche was 19.61% and 24.39%, respectively. The number of women needed to treat was five to avoid one niche formation. ALA use was associated with gastrointestinal upset in only three participants; however, none of the women withdrew during the study.
CONCLUSION: In women undergoing primary CS, the administration of ALA for 6 weeks postpartum improved uterine healing and decreased the incidence of scar niche.
METHODS: A parallel-group, triple-blind, placebo-controlled randomized clinical trial was conducted in Ain Shams University Maternity Hospital, Cairo, Egypt, involving 102 women undergoing pre-labor primary CS. The participants were randomly assigned using a computer-generated list of random numbers to receive oral ALA or a placebo twice daily for 6 weeks after CS. Allocation to either group was in a 1:1 ratio by an independent statistician (not involved in the treatment or data collection). The primary outcome was the presence of CS defect and measuring its depth and width. Secondary outcomes were measurements of the anterior myometrial and residual myometrium thicknesses, healing ratio and the presence of intrauterine adhesions. Assessment was done using saline contrast sonohysterography.
RESULTS: Twenty (39.2%) women in the treatment group and ten (19.6%) controls had no niche (P value = 0.03, 95% CI - 0.388, - 0.0037). The absolute and relative risk reduction of forming a niche was 19.61% and 24.39%, respectively. The number of women needed to treat was five to avoid one niche formation. ALA use was associated with gastrointestinal upset in only three participants; however, none of the women withdrew during the study.
CONCLUSION: In women undergoing primary CS, the administration of ALA for 6 weeks postpartum improved uterine healing and decreased the incidence of scar niche.