Use of an antispasmodic (rociverine) to shorten the length of labor: a randomized, placebo-controlled trial. The effect of hyoscine butylbromide on the first stage of labour in term pregnancies. The antiemetic efficacy and safety of prophylactic metoclopramide for elective cesarean delivery during spinal anesthesia. Antibiotic treatment of preterm labor with intact membranes: a multicenter, randomized, double-blinded, placebo-controlled trial. A randomised controlled study comparing Drotaverine hydrochloride and Valethamate bromide in the augmentation of labour. Effect of hyoscine-N-butyl bromide rectal suppository on labor progress in primigravid women: randomized double-blind placebo-controlled clinical trial. A randomised controlled trial and meta-analysis of active management of labour. A randomized trial of two preparations of vaginal prostaglandin for pre-induction cervical ripening. Antibiotic treatment in preterm labor and intact membranes: a randomized, double-blinded, placebo-controlled trial.
To determine the effectiveness of rociverine, an antispasmodic drug, for reducing the duration of labor among nulliparous women managed according to a standard intrapartum protocol.
                Randomized controlled trial.
                An academic tertiary care hospital.
                Nulliparae in spontaneous active labor, with cervical dilatation between 3 and 5 cm.
                Participants were randomly assigned to receive either an intramuscular injection of 20mg rociverine (n=55) or the same volume of saline (n=56).
                Cervical dilatation rate (from administration of study drug to full dilatation).
                Laboring women who received rociverine had faster cervical dilatation than those assigned to placebo (2.43 ± 1.84 vs. 1.85 ± 1.38 cm/hour, p=0.03). The time interval from treatment administration to full cervical dilatation was shorter in the rociverine group than in the placebo group (220 ± 125 vs. 278 ± 129 min, p=0.04). No difference was found in any other obstetric outcome. No adverse effects have been recorded from rociverine administration.
                Intrapartum administration of rociverine to nulliparous women may help to reduce the duration of the first stage of labor in a context of uniform labor management.
                © 2011 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2011 Nordic Federation of Societies of Obstetrics and Gynecology. To determine whether hyoscine butylbromide shortens the first stage of labour, without an increase in maternal or neonatal complications.
                Randomised, double-blinded, controlled trial.
                The Antenatal clinics and Labour and Delivery ward of the University Hospital of the West Indies, Kingston, Jamaica.
                Women in spontaneous labour at term.
                Either drug or placebo was given intravenously once the women entered active labour.
                The duration of the first stage of labour. Secondary outcomes included comparisons of the duration of the second and third stages of labour, blood loss at delivery, rate of caesarean section, and APGAR scores in the neonates between the two groups.
                A total of 129 women yielded data for analysis. Of these, 69 women received the placebo and 60 received hyoscine butylbromide. The mean time for the first stage in the control group was 228 minutes, compared with 156 minutes in the drug group, representing a decrease of 31.7% (P = 0.001). There was no significant change in the duration of the second and third stages of labour, and no difference in blood loss or in APGAR scores. There was a slight (but statistically insignificant) increase in the caesarean section rate.
                Hyoscine butylbromide is effective in significantly reducing the duration of the first stage of labour, and it is not associated with any obvious adverse outcomes in mother or neonate. The efficacy and safety of intravenous metoclopramide administered prophylactically before elective cesarean delivery under spinal anesthesia was studied.
                In a double-blind, randomized fashion, 42 ASA Physical Status I-II parturients at term were assigned to receive either 10-mg intravenous metoclopramide or an equal volume of normal saline before induction of spinal anesthesia. The occurrence of nausea and/or vomiting recorded throughout the perioperative period until the patient was admitted to the recovery room. Neonatal acid-base status and neurobehavioral exams were obtained.
                Patients in the group receiving metoclopramide had a significantly lower incidence of nausea and vomiting both before and after delivery than the control group (14% versus 81% overall). All neonatal acid-base values were within normal limits and there were no significant differences in neurobehavioral exam results between the two groups.
                Metoclopramide administered before induction of spinal anesthesia for cesarean delivery appears to significantly reduce both pre- and postdelivery emetic symptoms without apparent adverse effects on mother or neonate. Although an association between subclinical intrauterine infection and preterm birth is well established, there is conflicting evidence regarding the benefits of antibiotic administration to women in preterm labor with intact membranes. We attempted to determine the effect of ampicillin-amoxicillin and erythromycin treatment on prolongation of pregnancy, the rate of preterm birth, and neonatal morbidity in patients with preterm labor and intact membranes.
                A multicenter, randomized, double-blinded, placebo-controlled trial was designed and implemented by the Maternal-Fetal Medicine Units Network of the National Institute of Child Health and Human Development. Two hundred seventy-seven women with singleton pregnancies and preterm labor with intact membranes (24 to 34 weeks) were randomly allocated to receive either antibiotics or placebos.
                Of the 2373 patients screened for participation in this study in six medical centers, 277 women were enrolled (n = 133 for antibiotics group vs n = 144 for placebo group). In each study group, 60% of patients completed all the study medications. The overall prevalence of microbial invasion of the amniotic cavity was 5.8% (14/239). No significant difference between the antibiotic group and the placebo group was found in maternal outcomes, including duration of randomization-to-delivery interval, frequency of preterm delivery (< 37 weeks), frequency of preterm premature rupture of membranes, clinical chorioamnionitis, endometritis, and number of subsequent admissions for preterm labor. Similarly, no significant difference in neonatal outcomes could be detected between the two groups including respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage, sepsis, and admission and duration of newborn intensive special care unit hospitalization.
                The results of this study do not support the routine use of antibiotic administration to women in preterm labor with intact membranes. Cervical dilatation is a poorly understood process. Various drugs have been used to facilitate this process and reduce the duration of labour and thereby reduce feto-maternal complications. The present study is an attempt to compare and evaluate the efficacy of Drotaverine hydrochloride and Valethamate bromide in the process of cervical dilatation and labour augmentation.
                A prospective randomised trial of 146 low-risk women in spontaneous labour was conducted. 49 women were given Drotaverine (Group 1), 49 women were given Valethamate (Group 2) and 48 women were given placebo (Group 3). At 4 cm of cervical dilatation, elective amniotomy was done and the injection was given intramuscularly, and repeated every hour for a maximum of three doses.
                There was a statistically significant difference in the mean injection-delivery times (time from first injection to delivery of the baby), which was 183.2 min (SD 78.8) in the Drotaverine group compared to 206.5 min (SD 69.7) in the Valethamate group, and 245 min (SD 70.9) in the control group. The mean cervical dilatation rate (cm/h) was 3 (SD 1.4), 2.4 (SD 0.9) and 1.9 (SD 0.6) in groups 1, 2 and 3, respectively, and these differences were statistically significant. There were no statistically significant differences in the duration of second and third stage of labour. Transient side effects such as foeto-maternal tachycardia, flushing of the face and dryness of mouth were noted with Valethamate. A few patients complained of headache in the Drotaverine group.
                Both Drotaverine and Valethamate appear to significantly help cervical dilatation and augment first stage of labour. But, Drotaverine is superior to Valethamate with fewer side effects. To determine the effects of hyoscine-N-butyl bromide (HBB) rectal suppository on labor progress in primigravid women.
                A randomized double-blind placebo-controlled clinical trial was carried out on 130 primigravid women admitted for spontaneous labor. The women were recruited based on the inclusion and exclusion criteria and randomized into the experimental (n=65) and control group (n=65). In the beginning of the active phase of labor, 20 mg of HBB rectal suppository was administered to the experimental group, while a placebo suppository was administered to the control group. Cervical dilatation and duration of active phase and second stage of labor were recorded.
                The rate of cervical dilatation was 2.6 cm/h in the experimental and 1.5 cm/h in the control group (P<0.001). The active phase and the second stage of labor were significantly shorter in the experimental group (P=0.001 and P<0.001, respectively). There was no significant difference between the two groups in the fetal heart rate, maternal pulse rate, blood pressure, and the APGAR score 1 and 5 minutes after birth.
                Use of HBB rectal suppository in the active management of labor can shorten both the active phase and second stage of labor without significant side-effects. To test whether a policy of active management of nulliparous labour would reduce the rate of caesarean section and prolonged labour without influencing maternal satisfaction.
                Randomised controlled trial.
                Tertiary referral obstetric unit, Auckland, New Zealand.
                Nulliparous women in spontaneous labour at term with singleton pregnancy and cephalic presentation and without fetal distress.
                After the onset of active labour, previously consented women were randomly assigned to active management (n = 320) or to routine care (n = 331). Active labour was defined as regular painful contractions, occurring at least once in five minutes, lasting at least 40 seconds, accompanied by either spontaneous rupture of the membranes, or full cervical effacement and dilatation of at least two centimetres. Active management included early amniotomy, two-hourly vaginal assessments, and early use of high dose oxytocin for slow progress in labour. Routine care was not prespecified. Prolonged labour was > 12 hours duration. Maternal satisfaction with labour care was assessed by postal questionnaire at six weeks postpartum.
                Mode of delivery, duration of labour, and maternal satisfaction.
                Active management of labour did not reduce the rate of caesarean section 30/320 (9.4%), compared with 32/331 (9.7%) for routine care, but did shorten the length of first stage of labour (median 240 min vs 290 min; P = 0.02), and reduce the relative risk of prolonged labour (RR 0.39; 95% CI 0.22, 0.71). There were no differences between groups in the rates of newborn nursery admission, neonatal acidosis, low Apgar scores, or postpartum haemorrhage. Satisfaction with labour care was high (77%) and did not differ between groups.
                Active management of labour reduced the duration of the first stage of labour without affecting the rate of caesarean section, maternal satisfaction, or other maternal or newborn morbidity. To compare two prostaglandin (PG) E2 preparations for pre-induction cervical ripening in a randomized clinical trial.
                Two milligrams of vaginal PGE2 gel was compared with a vaginal PGE2 3-mg tablet in 200 nulliparous women. Outcomes assessed were induction failure, need for labor augmentation, pain relief requirements, fetal heart rate (FHR) abnormalities, operative delivery rate, induction-to-delivery interval, neonatal condition, and occurrence of uterine hyperstimulation.
                There was no statistical difference in pre- and post-dose cervical scores. Compared with the tablet group, women in the gel group were more likely to have significant FHR abnormalities in early labor (odds ratio [OR] 4.77, 95% confidence interval [CI] 1.15-19.5) requiring cesarean delivery. Fetal heart rate tracings in the active phase of labor were also more likely to be abnormal in the gel group (chi 2 = 4.31, P < .05). Compared with the gel group, women in the tablet group were significantly more likely to require operative delivery for poor progress in labor (OR 2.83, 95% CI 1.20-7.24). Other clinical outcomes were identical, with no significant differences in the overall rate of failed induction, cesarean delivery, rate of assisted delivery, requirement for oxytocin infusion, induction-to-delivery interval, pain relief requirements, or neonatal condition.
                When compared with the PGE2 tablet, the use of PGE2 gel for cervical ripening and labor induction in nulliparous women did not result in significant improvements in labor outcome. Whereas the gel was associated with an increase in significant FHR abnormalities, the tablet was associated with an increase in the rate of operative delivery for poor progress in labor. Although an association between microbial invasion of amniotic cavity and preterm birth has been extensively demonstrated, there is conflicting evidence regarding the benefits of antibiotic therapy in patients with preterm labor and intact membranes. We attempted to assess the efficacy of amoxicillin and erythromycin on pregnancy outcome in those patients. A randomized, double-blinded, placebo-controlled trial was designed and implemented. A total of 196 patients with singleton pregnancies and preterm labor with intact membranes (22-36 weeks) were randomly allocated to receive either antibiotics or placebo, plus adjunctive parenteral tocolysis, and 173 patients (antibiotics group n = 83 vs. placebo group n = 90) completed the treatment. The overall prevalence of microbial invasion of the amniotic cavity was 5.2% (9/173). No significant difference between both groups was found in maternal outcomes, including duration of randomization-to-delivery interval, frequency of preterm delivery, and frequency of clinical chorioamnionitis and endometritis. Rate of cesarean section was significantly higher in the placebo group (28% vs. 12%). Regarding neonatal outcome, no significant difference was detected between both groups in neonatal death, respiratory distress syndrome, proven sepsis, and birthweight. Suspected sepsis was significantly more frequent in the placebo group (6/90 vs. 0/78). The results of this trial indicate that amoxicillin and erythromycin do not prolong pregnancy in patients with preterm labor and intact membranes. A significant reduction in the rate of cesarean section was observed in patients receiving antibiotics. A significant reduction in the rate of neonatal suspected sepsis was also demonstrated.
There is low quality evidence that antispasmodics reduce the duration of first stage of labour and increase the cervical dilatation rate. There is very low quality evidence that antispasmodics reduce the total duration of labour. There is moderate quality evidence that antispasmodics do not affect the rate of normal vertex deliveries. There is insufficient evidence to make any conclusions regarding the safety of these drugs for both mother and baby. Large, rigorous randomised controlled trials are needed to evaluate the effect of antispasmodics on prolonged labour and to evaluate their effect on labour in a context of expectant management of labour.