Publication:

Comparison of efficacy of Drotaverine hydrochloride and Valethamate bromide in the augmentation of labour: a hospital based randomized trial

Background Labour is a process of contraction with the goal of producing progressive cervical effacement and dilatation in order to expel the uterine foetus from the intrauterine to the extra-uterine environment. The objective of this study was to compare the efficacy and safety of drotaverine hydrochloride and valethamate bromide for shortening the duration of labour.

Methods This randomized trial was conducted at R. G. Kar Medical College over one year. Total 360 primigravida or multigravidae mothers satisfying the criteria of having singleton term pregnancy with cephalic presentation with spontaneous onset of labour were included and allocated randomly into Drotavarine Group (Group 1) and Valethamate Group (Group 2).

Results There was statistically significant reduction of mean duration of first stage of labour both in primigravida (123.12±37.82 min versus 156.30±45.10 min) and multigravidae (102.75± 36.90 min versus 139.98±45.89 min) in Group 1 than Group 2. P value ˂0.0001 in each Group. The mean rate of cervical dilatation in Group 1 was 3.0±0.41 cm/hr and 3.5±0.414 cm/hr in primigravida and multigravidae respectively. 2.67±0.51 cm/hr in primigravida and 2.90±0.44cm/hr in multigravidae in Group 2. It was statistically significant (p˂0.0001 in both Groups). Mean injection to delivery interval both in primigravida and multigravidae of Group 1 were significantly less than Group 2 (p=0.0006 and p˂0.0001 respectively). Modes of delivery were comparable in both Groups (p=0.756). Few maternal complications like transient tachycardia was more (12) in VB Group in compare to DH (3). Although it was not statistically significant (p=0.268). Foetal complications including Apgar score at 1 min and 5 min in both Groups were comparable in both primigravida and multigravidae (P value 0.39718 and 0.285 respectively).

Conclusions Drotaverine hydrochloride has promising beneficial effects on labour and it is safe to use.