| Objectives:To identify the prophylactic efficacy of Fu Qingzhu’s Bao Chan Wu You Fang for cephalic dystocia.Methods:A prospective, randomized, controlled trial (TRIAL REGISTRATION: ChiCTR-TRC-14004838) was conducted between March 2014 and April 2015. Of 289 hospitalized expectant mothers assessed for eligibility,150 were randomized. Inclusion criteria were pregnancy in term, single birth, primiparity, cephalic presentation, and mild cephalopelvic disproportion. Gravidas in the intervention group (n= 75) took 200 ml of Fu Qingzhu’s Bao Chan Wu You Fang decoction orally twice daily from threatened labor through in labor besides receiving routine labor management, while those in control group (n = 75) receive routine labor management alone. The primary outcome points was the proportions of dystocia. The secondary outcome points included delivery route, contraction stress test(CST) results, fetal distress, neonatal asphyxia, perineal laceration, and volume of postpartum hemorrhage. Binary Logistic regression analysis was used in order to identify factors associated with dystocia.Results:The proportions of dystocia in intervention group and control group were 26.7%(20/75)and 53.3%(40/75), respectively [χ2=11.111, P= 0.001. relative risk(RR) was 0.500(95% confidence interval (CI),0.325-0.769)]. Binary Logistic regression analysis indicated that body heights, abdomen circumferences of expectant mothers at study entry and intervention (i.e., Fu Qingzhu’s Bao Chan Wu You Fang administration by oral) were significantly associated with lower risk for dystocia. The multivariate-adjusted odds ratio (OR) (95% CI) of dystocia was 0.258 (0.122-0.544) (P< 0.001) for intervention vs control, 1.141(1.030-1.263) (P= 0.011) for body heights and 0.913 (0.852-0.978) (P= 0.010) for abdomen circumferences, respectively. Constituent ratios of spontaneous, cesarean section, operative vaginal delivery in the two groups were 73.3%(55/75) and 24.0%(18/75),2.7%(2 /75)and 46.7%(35/75),38.7%(29/75)and 14.7%(11/75),respectively,respectively(χ2= 13.250,P=0.001),of fetal distress were 5.3%(4/75)and 17.3%(13/75),respectively [χ2=5.374,P=0.020；RR=0.308(95%CI:0.105.0.901)],of type Ⅰ,type Ⅱ,type Ⅲ of CST results were 74.7%(56/75)and 21.3%(16/75),4.0%(3/75)and 54.7%(41/75), 29.3%(22/75)and 16.0%(12/75),respectively,respectively[Z=-2.786,P=0.005].The median volume of blood loss within the first 24 hours after delivery were 240 (interquartile,185,350)ml in the intervention group and 270(230,380)ml in the controls, respectively(z=-2.325,P=0.020).The constituent ratios of degree 0,degree 1,degree 2 of perineal laceration in intervention group and control group were 7.0%(4/57),59.7%(34 /57),33.3%(19/57)and 2.2%(1/46),45.6%(21/46),52.2%(24/46),respectively, respectively(z=-2.050,P=0.040).No statistical differences were found in proportions of fetal distress,neonatal asphyxia or postpartum hemorrhage between the two groups.Conclusions:Fu Qingzhu’s Bao Chan Wu You Fang can reduce the risks for cephalic dystocia and fetal distress. |
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