Tocolysis for repeat external cephalic version in breech presentation at term: a randomised, double-blinded, placebo-controlled trial. A prospective randomised controlled trial of external cephalic version comparing two methods of uterine tocolysis with a non-tocolysis group. Oral nifepidine versus subcutaneous terbutaline tocolysis for external cephalic version: a double-blind randomised trial. Tocolysis in term breech external cephalic version. External cephalic version at term. A randomized controlled trial using tocolysis. A double-blind randomized comparison of lidocaine and saline for cervical anesthesia. Randomized comparison of intravenous nitroglycerin and magnesium sulfate for treatment of preterm labor. Extraamniotic saline infusion is promising in preparing the cervix for induction of labor. A randomized trial of external cephalic version with tocolysis in late pregnancy.
External cephalic version (ECV) reduces the incidence of breech presentation at term and caesarean section for non-cephalic births. Tocolytics may improve success rates, but are time consuming, may cause side effects and have not been proven to alter caesarean section rates. The aim of this trial was to determine whether tocolysis should be used if ECV is being re-attempted after a failed attempt.
                To determine whether tocolysis should be used if ECV is being re-attempted after a failed attempt.
                Randomised, double-blinded, placebo-controlled trial.
                UK teaching hospital.
                One hundred and twenty-four women with a breech presentation at term who had undergone an unsuccessful attempt at ECV.
                Relative risks with 95% confidence intervals for categorical variables and a t test for continuous variables. Analysis was by intention to treat.
                Incidence of cephalic presentation at delivery. Secondary outcomes were caesarean section and measures of neonatal and maternal morbidity.
                The use of tocolysis for a repeat attempt at ECV significantly increases the incidence of cephalic presentation at delivery (RR 3.21; 95% CI 1.23-8.39) and reduces the incidence of caesarean section (RR 0.33; 95% CI 0.14-0.80). The effects were most marked in multiparous women (RR for cephalic presentation at delivery 9.38; 95% CI 1.64-53.62). Maternal and neonatal morbidity remain unchanged.
                The use of tocolysis increases the success rate of repeat ECV and reduces the incidence of caesarean section. A policy of only using tocolysis where an initial attempt has failed leads to a relatively high success rate with minimum usage of tocolysis. The use of tocolvtic agents to enhance uterine relaxation and facilitate external cephalic version (ECV) has come under recent debate. We studied 90 breech presentations in late pregnancy who did not have contra-indications to ECV. The patients were randomised into 3 groups of 30 patients each: one was administered oral salbutamol 4 mg t.d.s.; another had intravenous salbutamol infused until the maternal heart rate rose above 100 bpm for 30 mins; and the last served as a control group. All patients in each group were matched for parity and gestation, and each had an intravenous line, thereby masking the treatment group from the 2 doctors who performed half the number of ECVs each. There was no significant difference in the success of ECV between the treatment and control groups (46.6% vs 50.0% vs 46.6%). The gestational age, the placental site, the attitude of the breech, the abdominal girth, and the maternal weight and fetal birth weights did not seem to influence results. On the other hand, there was a significant difference in successful ECV between nullipara (26%) and multipara (75%) (p less than 0.001). There were no cases of abruptio placenta or foetal distress, and one patient entered labour one day after the ECV at 39 weeks gestation. There were 2 cases of spontaneous version after failed ECV, and one case of spontaneous reversion to breech after successful ECV. We conclude that the use of salbutamol does not increase the incidence of successful ECV, but multiparity predicts for a successful outcome. To evaluate oral nifedipine versus subcutaneous terbutaline tocolysis for external cephalic version (ECV).
                A double-blind randomised trial.
                A university hospital in Malaysia.
                Non-labouring women with a term singleton fetus in breech presentation or transverse lie suitable for elective ECV.
                Participants were randomised to either 10 mg oral nifedipine tablet and subcutaneous saline placebo or oral placebo tablet and 250 microgram bolus terbutaline subcutaneously. Participants and providers were blinded. Ultrasound assessment and cardiotocogram were performed prior to ECV. ECV was commenced 20-30 minutes after treatment. A maximum of two ECV attempts were permitted. Elective caesarean delivery or a repeat ECV attempt at a later date was offered to participants following failed ECV. After successful ECV, management was expectant.
                Primary outcomes were successful ECV (cephalic presentation immediately after ECV) and caesarean delivery.
                Ninety women were randomised: 44 to nifedipine and 46 to terbutaline. Initial ECV success rate was 15/44 (34.1%) versus 24/46 (52.2%) (relative risk [RR] 0.7, 95% CI 0.4-1.1; P= 0.094), and caesarean delivery rate was 34/44 (77.3%) versus 26/46 (56.5%) (RR 1.4, 95% CI 1.01-1.85; numbers needed to treat to benefit 5, 95% CI 2.5-55; P= 0.046) for nifedipine and terbutaline groups, respectively. Neonatal outcome was not different.
                Bolus subcutaneous terbutaline tocolysis for ECV compared with oral nifedipine resulted in less caesarean deliveries. ECV success rate was not significantly higher. Larger studies are indicated. To study the effect of ritodrine tocolysis on the success of external cephalic version (ECV) and to assess the role of ECV in breech presentation at our centre.
                A prospective randomized double-blind-controlled trial comparing ritodrine and placebo in ECV of singleton term breech pregnancy at a tertiary hospital.
                Among the 60 patients who were recruited, there was a success rate of 36.7%. Ritodrine tocolysis significantly improved the success rate of ECV (50% vs. 23%; P=0.032). There was a marked effect of ritodrine tocolysis on the ECV success in nulliparae (36.4% vs. 13.0%) and multiparae (87.5% vs. 57.1%). External cephalic version has shown to reduce the rate of cesarean section for breech presentation by 33.5% in our unit.
                External cephalic version significantly reduced the rate of cesarean section in breech presentation, and ritodrine tocolysis improved the success of ECV and should be offered to both nulliparous and parous women in the case of term breech presentation. To assess the role of external cephalic version (ECV) at term, using tocolysis.
                A randomized controlled trial over a 12 month period.
                Harare Maternity Hospital, Harare, Zimbabwe.
                208 women with breech presentation at term were recruited after satisfying eligibility criteria. There were 103 women in the study group and 105 in the control group. At the end of the study a further 104 women were recruited for ECV.
                ECV attempted after intravenous injection of 10 micrograms of hexaprenaline, using either forward or backward somersault over a maximum period of 5 min.
                Success rate in terms of presentation during labour, need for caesarean section, and various variables related to fetal outcome.
                ECV reduced the frequency of breech presentation during labour from 83% to 17% and that of caesarean section from 33% to 13%. There were no troublesome complications from the procedure.
                In carefully selected women with breech presentation, ECV at term using tocolysis, safely reduced the rate of breech presentation in labour and also the caesarean section rate. Further research is needed to determine the role of ECV in early labour. To compare bacteriostatic saline and buffered lidocaine for cervical anesthesia to blunt the reported pain during brief suction curettage.
                A double-blind randomized clinical trial was conducted on women presenting for pregnancy termination procedures. Participants received either paracervical submucosal injections of bacteriostatic saline or 1% buffered lidocaine just before cervical dilation. Self-reported pain intensity was assessed at three time points during and 30 minutes after the procedure.
                Fifty-two of 135 eligible women presenting for pregnancy termination procedures participated in the study. Pain intensity ratings in lidocaine and saline treatment subjects did not differ significantly at any point. Our study had a power of 0.94 to detect more than a 15% difference on the 21-point box scale between the two solutions. Only one patient requested her block be repeated, and she had received lidocaine originally. Furthermore, of those women receiving lidocaine, 11% reported mild toxicity symptoms.
                To minimize lidocaine toxicity for a brief suction curettage procedure, bacteriostatic saline or very dilute lidocaine could be considered for the paracervical injection solution. The local anesthetic mechanism may be distention rather than blockage of specific autonomic nerves when there is no waiting period. This would mean that the term paracervical block could be changed to cervical anesthesia. To compare the safety and efficacy of high-dose intravenous (IV) nitroglycerin with those of IV magnesium sulfate for acute tocolysis of preterm labor.
                Thirty-one women with preterm labor before 35 weeks' gestation were assigned randomly to IV magnesium sulfate or IV nitroglycerin for tocolysis. Preterm labor was defined as the occurrence of at least two contractions in 10 minutes, with cervical change or ruptured membranes. Acute tocolysis was defined as tocolysis for up to 48 hours. Magnesium sulfate was administered as a 4-g bolus, then at a rate of 2-4 g/h. Nitroglycerin was administered as a 100-microg bolus, then at a rate of 1- to 10-microg/kg/min. The primary outcome measure was achievement of at least 12 hours of successful tocolysis.
                Thirty patients were available for analysis. There were no significant differences in gestational age, cervical dilation, or incidence of ruptured membranes between groups at the initiation of tocolysis. Successful tocolysis was achieved in six of 16 patients receiving nitroglycerin, compared with 11 of 14 receiving magnesium sulfate (37.5 versus 78.6%, P = .033). Tocolytic failures (nitroglycerin versus magnesium sulfate) were due to persistent contractions with cervical change or rupture of previously intact membranes (five of 16 versus two of 14), persistent hypotension (four of 16 versus none of 14), and other severe side effects (one of 16 versus one of 14). Maternal hemodynamic alterations were more pronounced in patients who received nitroglycerin, and 25% of patients assigned to nitroglycerin treatment had hypotension requiring discontinuation of therapy.
                Tocolytic failures were more common with nitroglycerin than with magnesium sulfate. The hemodynamic alterations noted in patients receiving nitroglycerin, including a 25% incidence of persistent hypotension, might limit the usefulness of IV nitroglycerin for the acute tocolysis of preterm labor. The application of local prostaglandins before induction of labor in women with an unripe cervix is standard procedure in Sweden. Side effects include uterine hypertonus and occasionally fetal heart rate abnormalities. Failed ripening is reported in up to 25% of cases. A previous report of ripening of the cervix by use of extraamniotic physiologic saline infusion through a Foley catheter applied in the cervix claimed results superior to topical prostaglandins.
                To conduct a prospective randomized trial of extraamniotic saline infusion and intracervical application of dinoprost 0.5 mg on cervical ripening and outcome of labor.
                Eighty-five term singleton pregnant women with unripe cervices where induction of labor was indicated were randomized to prostaglandin or saline infusion after obtaining informed consent. Outcome variables were improvement of cervical score, induction delivery time and mode of delivery.
                The 42 women in the saline infusion group obtained significantly (p < or = 0.001) higher cervical scores and shorter induction delivery intervals (p < or = 0.005) than the 43 women in the prostaglandin group. Cases of unripe cervix after 24 hours were significantly (p < or = 0.01) fewer in the saline group. There were more Cesarean sections in the saline group, but this difference was not significant. Saline infusion did not induce uterine activity and oxytocin was given in every case after the expulsion of the catheter.
                In this study extraamniotic saline infusion was a more efficacious method for ripening of the cervix than intracervical prostaglandin. The absence of early painful contractions is an advantage, but effective stimulation of labor is required to effect delivery after maturation of the cervix. The effect of external version under tocolysis with intravenous ritodrine during the 37th week of gestation was studied in a prospective randomized trial comprising 130 consecutive women with a fetus in breech presentation. Version was successful in 41% of the patients, all of whom had a cephalic vaginal delivery. Of the 56 women in the control group in whom version was not attempted; 8 (14%) converted to the vertex presentation spontaneously. Failure of version was significantly correlated with primiparity, location of the placenta on the anterior uterine wall, and maternal weight. The caesarean section rate was significantly lower in the version group (27%) than in the control group (46%) (P less than 0.05). The overall caesarean section rate for a fetus in breech presentation was 50%. There were no serious complications associated with version and the condition of the infants at birth was better in the version group than in the control group. We advise external version under tocolysis in late pregnancy to reduce the frequency of breech presentation in labour.
Betastimulants, to facilitate ECV, increased cephalic presentation in labour and birth, and reduced the caesarean section rate in both nulliparous and multiparous women, but there were insufficient data on adverse effects. Calcium channel blockers and nitric acid donors had insufficient data to provide good evidence. At present we recommend betamimetics for facilitating ECV.
There is scope for further research. The possible benefits of tocolysis to reduce the force required for successful version and the possible risks of maternal cardiovascular side effects, need to be addressed further. Further trials are needed to compare the effectiveness of routine versus selective use of tocolysis, the role of regional analgesia, fetal acoustic stimulation, amnioinfusion and the effect of intravenous or oral hydration prior to ECV.
Although randomised trials of nitroglycerine are small, the results are sufficiently negative to discourage further trials.