Outpatient balloon catheter vs inpatient prostaglandin for induction of labour (OBLIGE): a randomised controlled trial.

BACKGROUND: Approximately one in four pregnant women undergo an induction of labour. The purpose of this study is to investigate the clinical effectiveness, safety, and cost-effectiveness for mothers and babies of two methods of cervical ripening - inpatient care for women starting induction with vaginal prostaglandin E2 hormones, or allowing women to go home for 18 to 24 h after starting induction with a single-balloon catheter. METHODS/DESIGN: This is a multi-centre randomised controlled trial in New Zealand. Eligible pregnant women, with a live singleton baby in a cephalic presentation who undergo a planned induction of labour at term, will be randomised to outpatient balloon-catheter induction or in-hospital prostaglandin induction. The primary outcome is caesarean section rate. To detect a 24% relative risk reduction in caesarean rate from a baseline of 24.8%, with 80% power and 5% type 1 error, will require 1552 participants in a one to one ratio. DISCUSSION: If outpatient balloon-catheter induction reduces caesarean section rates, has additional clinical benefits, and is safe, cost-effective, and acceptable to women and clinicians, we anticipate change in induction of labour practice around the world. We think that home-based balloon-catheter induction will be welcomed as part of a patient-centred labour-induction care package for pregnant women. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12616000739415. Registered on 6 June 2016.

What can we do to reduce the associated costs in induction of labour of intrauterine growth restriction foetuses at term? A cost-analysis study.

OBJECTIVE: To evaluate the costs associated with induction of labour in intrauterine growth restriction fetuses comparing different procedures. STUDY DESIGN: 150 pregnancies at term diagnosed with intrauterine growth restriction and indication for induction of labour were included. 24 were ripened with misoprostol 25 µg tablets, 24 with dinoprostone 10 mg vaginal insert, and 77 with Cook® cervical ripening balloon. To determine the costs of induction of labour, method of induction, intrapartum medication, epidural analgesia, type of delivery, and maternal and neonatal admissions were considered. Statistical analysis was performed using the G-Stat 2.0 free statistical software. ANOVA test was used for comparisons between quantitative parametric variables. Chi-squared test or Fisher test was used for qualitative variables. A value of p < 0.05 was considered statistically significant. RESULTS: Up to 70.83% women in dinoprostone group gave birth within the first 24 h compared to 42.66% in misoprostol group and 36.36% in CG (p < 0.01). Misoprostol tablets were cheaper (9.45 ± 1.52 US dollars) than dinoprostone or Cook® balloon (41.67 ± 0 and 59.85 ± 0 54.45 ± 0 US dollars, respectively) (p < 0.01). Costs related to maternal admissions were higher in CG (475.13 ± 146.95$) than dinoprostone group (475.13 ± 146.95$) or MG (427.97 ± 112.65$) (p = 0.03). Total costs in misoprostol group (2765.18 ± 495.38$) were lower than in the dinoprostone group (3075.774 ± 896.14$) or Cook® balloon group (3228.02 ± 902.06$) groups. CONCLUSIONS: Misoprostol for induction of labour had lower related costs than dinoprostone or Cook® balloon, with similar obstetrical and perinatal outcomes.

Induction of labor using prostaglandin vaginal gel: cost analysis comparing early amniotomy with repeat prostaglandin gel.

BACKGROUND: In a randomized controlled trial of two policies for induction of labor (IOL) using Prostaglandin E2 (PGE2) vaginal gel, women who had an earlier amniotomy experienced a shorter IOL-to-birth time. OBJECTIVE: To report the cost analysis of this trial and determine if there are differences in healthcare costs when an early amniotomy is performed as opposed to giving more PGE2 vaginal gel, for women undergoing IOL at term. STUDY DESIGN: Following an evening dose of PGE2 vaginal gel, 245 women with live singleton pregnancies, ≥37+0 weeks, were randomized into an amniotomy or repeat-PGE2 group. Healthcare costs were a secondary outcome measure, sourced from hospital finance systems and included staff costs, equipment and consumables, pharmacy, pathology, hotel services and business overheads. A decision analytic model, specifically a Markov chain, was developed to further investigate costs, and a Monte Carlo simulation was performed to confirm the robustness of these findings. Mean and median costs and cost differences between the two groups are reported, from the hospital perspective. RESULTS: The healthcare costs associated with IOL were available for all 245 trial participants. A 1000-patient cohort simulation demonstrated that performing an early amniotomy was associated with a cost-saving of $AUD289 ($AUD7094 vs $AUD7338) per woman induced, compared with administering more PGE2. Propagating the uncertainty through the model 10,000 times, early amniotomy was associated with a median cost savings of $AUD487 (IQR -$AUD573, +$AUD1498). CONCLUSIONS: After an initial dose of PGE2 vaginal gel, a policy of administering more PGE2 when the Modified Bishop's score is <7 was associated with increased healthcare costs compared with a policy of performing an amniotomy, if technically possible. Length of stay was the main driver of healthcare costs.

A comparison of obstetrical outcomes and costs between misoprostol and dinoprostone for induction of labor.

OBJECTIVE: The objective of this study is to compare resource utilization (efficiency) and obstetrical/cost outcomes of single dose misoprostol versus dinoprostone for induction of labor (IOL) at term. METHODS: Retrospective cohort of induced deliveries 37-41 weeks gestation presenting with a Bishop score ≤4 using single-dose-50 mcg vaginal misoprostol or 10 mg-dinoprostone vaginal-inserts. Dinoprostone patients were compared (5:1) with misoprostol patients. The primary outcome variable was length of L&D stay (proxy for resource utilization). Baseline characteristics, clinical outcomes, and costs were compared. RESULTS: Three-hundred thirty-one patients were included, 276 received dinoprostone and 55 received misoprostol. The misoprostol group had statistically significant decreased time to active labor [median 8 h (1.6,24) versus 12(0.8,52)], time-to-delivery [median 11 h (4,31) versus 17(2.8,56)] and L&D stay [median 16 h (13,28) versus 24(18,30)]. Differences remained significant after adjustment for race, method of delivery, birth weight, gravidity/parity, gestational age, and BMI (adjusted p values <0.001, <0.01, and < 0.05, respectively). There were no statistical differences in Apgar scores, tachysystole rate, cesarean section rate, and composite maternal/neonatal morbidity. A policy of using misoprostol would result in annual cost savings of approximately $242 500 at our institution as compared with dinoprostone. CONCLUSION: Single-dose misoprostol is more efficient in IOL at term with respect to L&D utilization and cost and its use is not associated with increased adverse obstetrical outcomes.

Cost-effectiveness of induction of labour at term with a Foley catheter compared to vaginal prostaglandin E2 gel (PROBAAT trial).

OBJECTIVE: To assess the economic consequences of labour induction with Foley catheter compared to prostaglandin E2 gel. DESIGN: Economic evaluation alongside a randomised controlled trial. SETTING: Obstetric departments of one university and 11 teaching hospitals in the Netherlands. POPULATION: Women scheduled for labour induction with a singleton pregnancy in cephalic presentation at term, intact membranes and an unfavourable cervix; and without previous caesarean section. METHODS: Cost-effectiveness analysis from a hospital perspective. MAIN OUTCOME MEASURES: We estimated direct medical costs associated with healthcare utilisation from randomisation to 6 weeks postpartum. For caesarean section rate, and maternal and neonatal morbidity we calculated the incremental cost-effectiveness ratios, which represent the costs to prevent one of these adverse outcomes. RESULTS: Mean costs per woman in the Foley catheter group (n = 411) and in the prostaglandin E2 gel group (n = 408), were €3297 versus €3075, respectively, with an average difference of €222 (95% confidence interval -€157 to €633). In the Foley catheter group we observed higher costs due to longer labour ward occupation and less cost related to induction material and neonatal admissions. Foley catheter induction showed a comparable caesarean section rate compared with prostaglandin induction, therefore the incremental cost-effectiveness ratio was not informative. Foley induction resulted in fewer neonatal admissions (incremental cost-effectiveness ratio €2708) and asphyxia/postpartum haemorrhage (incremental cost-effectiveness ratios €5257) compared with prostaglandin induction. CONCLUSIONS: Foley catheter and prostaglandin E2 labour induction generate comparable costs.

[Mechanisms, clinical profile and role of prostaglandin and prostamide analogues in antiglaucomatous therapy]. / Wirkmechanismen, klinisches Profil und Stellenwert von Prostaglandin- und Prostamid-Analoga in der antiglaukomatösen Therapie.

Prostaglandin and prostamide analogues belong to a new substance group which came into the market in the 1990s. They have revolutionised antiglaucomatous therapy by their once-daily dosing regimen and fewer side effects. Today, prostaglandin and prostamide analogues are approved as first-line therapy for patients with primary open-angle glaucoma and ocular hypertension. They lower the intraocular pressure primarily by increasing the uveoscleral outflow. Recent investigations have shown that they also improve the trabecular outflow facility and thus the conventional outflow pathways. Prostaglandin and prostamide analogues are highly efficient in lowering the intraocular pressure, for which they are superior to other antiglaucomatous substance groups. In particular, they appear to have a good control of 24-hour intraocular pressure fluctuations by primarily improving the outflow pathways. Furthermore, they have less systemic side effects than ß-blockers. However, their use is often associated with higher costs. In case of undesirable events, they mostly present with ocular symptoms. Based on their good clinical profile, prostaglandin and prostamide analogues play an important role in the primary and additive therapy for glaucoma.

[Comparison of isosorbide dinitrate and dinoprostone for induction of labor in term pregnancy]. / Isosorbide y dinoprostona en inducción del trabajo de parto.

BACKGROUND: it has been suggested that nitric oxide generators, such as isosorbide dinitrate, may be an alternative to mimic the effects of signal transduction mechanisms leading to cervical ripening, without affecting uterine contractility. OBJECTIVE: to compare the isosorbide dinitrate and dinoprostone for induction of labor in term pregnancy. MATERIAL AND METHODS: in a randomized controlled blinded clinical trial, we studied 66 patients divided into 2 groups: 33 patients were given 20 mg of isosorbide dinitrate and to the other 33 were administered 0.5 mcg of dinoprostone; in both groups the drugs were administered vaginally each 6 h and at maximum 3 times. It was carried out a cardiotocographic study in order to determine the presence or absence of uterine activity and to exclude disorders of the fetal heart frequency; it was performed a vaginal examination to assess cervical conditions determining the Bishop score at 0, 6 and 12 h. RESULTS: there were no differences between the groups in the determinations of mean arterial pressure, maternal heart frequency, fetal heart frequency and Bishop score registered at 6 y 12 h followed the drugs administration. The time of delivery was 20.7 +/- 1.8 h in the group of women treated with dinoprostone; and 16.3 +/- 1.4 h in women treated with isosorbide dinitrate (p=0.032). The cost was higher in women treated with dinoprostone ($560 vs $12, respectively, p=0.001). There was no difference between the groups related to: frequency of meconium stained liquid (p=1.000), mode of delivery by caesarean section (p=0.918), Apgar score at 1 minute (p=0.764) and 5 minutes (p=0.294) and mother discharged with healthy baby (p=1.000). CONCLUSIONS: the isosorbide dinitrate is associated with lower duration of labor compared with dinoprostone. There was no difference in the maternal-fetal outcome by using whatever drug.

[Structural sensitivity analysis]. / Análisis de sensibilidad estructural.

The aim of this study was to perform a structural sensitivity analysis of a decision model and to identify its advantages and limitations. A previously published model of dinoprostone was modified, taking two scenarios into account: eliminating postpartum hemorrhages and including both hemorrhages and uterine hyperstimulation among the adverse effects. The result of the structural sensitivity analysis shows the robustness of the underlying model and confirmed the initial results: the intrauterine device is more cost-effective than intracervical dinoprostone gel. Structural sensitivity analyses should be congruent with the situation studied and clinically validated. Although uncertainty may be only slightly reduced, these analyses provide information and add greater validity and reliability to the model.

Is expensive always better? Comparison of two induction agents for term rupture of membranes.

The aim of this study was to compare the clinical safety and efficacy of sublingual misoprostol with vaginal prostaglandin E2 (Prostin(R)) as an induction agent after term rupture of membranes. This was a non-blinded randomised control study involving 57 women who were >24-48 h after term rupture of membranes. In total, 29 women received sublingual misoprostol and 28 received Prostin. The mean induction of labour to delivery time was 20.71+/-11.59 h in the Prostin group and 13.96+/-9.90 h in the misoprostol group, (p = 0.021). Some 46.4 % (13/28) of the Prostin group needed a second dose compared with only 20.7 % (6/29) of the misoprostol group (p = 0.039). Oxytocin infusion was used by 57% (16/28) of the Prostin group compared with 31% (9/29) of those who had received misoprostol, (p = 0.047). In our study, sublingual misoprostol when compared with vaginal prostaglandin E2 gel (Prostin) leads to a shorter induction to labour time, and less need for second dose of induction agent or oxytocin infusion. Women were given a satisfaction questionnaire to complete after delivery. Those who were given misoprostol were satisfied with the outcome, would use it again in the future, and recommend it to friends in similar circumstances.

A comparison of oral misoprostol tablets and vaginal prostaglandin E2 pessary in induction of labour at term.

OBJECTIVE: To compare the cost-effectiveness, mode of delivery, fetal and maternal outcome of oral Misoprostol and vaginal prostaglandin E2 pessary in induction of labour at term. DESIGN: Randomized clinical trial. PLACE AND DURATION OF STUDY: Hamdard University Hospital, Imam Clinic and General Hospital from February 2002 to January 2003. PATIENTS AND METHODS: The trial was conducted over two groups of patient for labour induction such that Group A received 50 microg oral Misoprostol 4 hourly to a maximum of four doses. Group B received prostaglandin E2 vaginal pessary at 6 hourly intervals upto two doses. Labour induction, number of doses, need of augmentation, induction to delivery time interval, mode of delivery and neonatal outcome were the main outcomes. Test of proportions was used to compare the significance between both managements. RESULTS: Out of a total of 214 women, 106 received oral Misoprostol and 108 received PGE2 vaginal pessary. Ninety-three percent women in misoprostol group were successfully induced compared with 91% in PGE2 group. A significant response of labour induction with the minimal dose (58%, p = 0.001) and earlier induction to vaginal delivery (74%, p = 0.01) was observed in Misoprostol group. Rate of operative delivery was also less (16%, p = 0.16) compared with PGE2 group (25%). CONCLUSION: Oral Misoprostol administration was more efficient and cost-effective than PGE2 vaginal pessary for induction of labour due to earlier response with minimal dose and less number of operative deliveries.

Comparative efficacy and cost of the prostaglandin analogs dinoprostone and misoprostol as labor preinduction agents.

OBJECTIVE: The purpose of this study was to compare the relative efficacy and cost of three commercially available prostaglandin analogs, misoprostol (Cytotec), dinoprostone gel (Prepidil), and dinoprostone insert (Cervidil), as labor preinduction agents. STUDY DESIGN: One-hundred eleven women with an unfavorable cervix who underwent labor induction were assigned randomly to receive either misoprostol 50 microg every 6 hours for two doses, dinoprostone gel 0.5 mg every 6 hours for two doses, or dinoprostone insert 10 mg for one dose intravaginally. Twelve hours later, oxytocin induction was initiated per standardized protocol. Efficacy and cost of the labor preinduction/induction with the study treatments were compared. RESULTS: Mean Bishop score change (+/-SD) over the initial 12-hour interval was significantly greater in the misoprostol group (5.2 +/- 3.1) compared with the dinoprostone insert (3.2 +/- 2.3) or the dinoprostone gel groups (2.2 +/- 1.3, P <.0001). The proportion of women who reached complete dilation (68.4%, 50.0%, 51.4%, respectively; P =.14) and who were delivered (60.5%, 47.4%, 40.0%, respectively; P =.10) within 24 hours of the initiation of induction were not significantly different between the misoprostol, dinoprostone insert, and dinoprostone gel groups. Induction-to-delivery intervals, however, were significantly shorter among women who treated with misoprostol (24.0 +/- 10.8 hours) compared with either the dinoprostone gel (31.6 +/- 13.4 hours) or the dinoprostone insert (32.2 +/- 14.7 hours, P <.05). Overall mean cost per patient that was incurred by labor induction was significantly less for the misoprostol group ($1036.13) compared with the dinoprostone insert group ($1565.72) or the dinoprostone gel group ($1572.92, P <.0001). No significant differences were noted with respect to the mode of delivery or to the adverse maternal/neonatal outcome. CONCLUSION: Misoprostol is more cost-effective than the comparable commercial dinoprostone prostaglandin preparations as an adjuvant to labor induction in women with an unfavorable cervix.

Induction of labor by prostaglandin E(2) in relation to the Bishop score.

OBJECTIVE: To compare the effectiveness of prostaglandin E(2) intravaginal gel with the intracervical gel in patients with an unfavorable cervix. METHOD: In a prospective multicenter trial 470 patients with unfavorable Bishop scores (3-4) were randomized to receive prostaglandin vaginal gel (2 mg) or intracervical gel (0.5 mg). RESULTS: In patients with unfavorable Bishop scores the intravaginal application route resulted in a better cervical ripening, a shorter induction to delivery interval and a higher cumulative rate of deliveries during 24 h (P=0.01). CONCLUSION: Intravaginal instillation of prostaglandin E(2) gel for induction of labor is effective in patients with an unfavorable Bishop score of 3-4.

Comparing two dinoprostone agents for preinduction cervical ripening at term. A randomized trial.

OBJECTIVE: To compare the safety, efficacy and cost of two methods of administering commercially available dinoprostone for preinduction cervical ripening at term. STUDY DESIGN: Sixty-nine women admitted for labor induction were randomized to receive one of two commercially available agents for cervical ripening. Half the patients received a gel containing 0.5 mg of dinoprostone placed intracervically every four hours. The other half received a polymer insert containing 10 mg of dinoprostone intravaginally. After 12 hours of cervical ripening, oxytocin was given and amniotomy performed to induce labor. RESULTS: Among 69 women randomized, 35 received the gel and 34 the polymer. No significant differences were noted between the two groups in starting characteristics or indication for induction. Both groups were similar with respect to change in Bishop score, start-to-delivery interval, amount of oxytocin required, mode of delivery and success of induction. A slightly higher rate of hyperstimulation was noted in the polymer group, although this did not lead to fetal or maternal morbidity. The average costs per patient for the two agents were similar. CONCLUSION: The two dinoprostone agents are similar with respect to efficacy. The polymer group had slightly more complications but without adverse fetal or maternal outcomes. A larger, multicenter trial would be required to determine actual differences in the efficacy, safety and cost of these two agents.

Vaginal misoprostol for term labor induction.

Misoprostol is an effective agent for cervical ripening and induction of labor. The use of oxytocin was significantly decreased in patients treated with misoprostol versus dinoprostone. It has been used to induce over 1000 women in reported studies and has demonstrated a safety profile comparable with that of endocervical and vaginal dinoprostone. Uterine hyperstimulation was a concern in earlier trials, but at a reduced dose of 25 micrograms, the incidence has decreased to a level that is comparable with the values reported for dinoprostone. Misoprostol tablets are stable at room temperature and are considerably less expensive than the dinoprostone alternatives. Two additional factors pertaining to misoprostol administration must be taken into account before the drug is selected for vaginal use. First, Cytotec tablets are currently available in two strengths, 100 and 200 micrograms. This can lead to confusion or error if the clinician orders a quarter or half tablet. The order should always identify the strength in micrograms (25 or 50 micrograms). Second, the 100-microgram tablet is not scored; therefore, the proper dose should be carefully prepared by a pharmacist using a pill cutter. Key members of the hospital staff must be trained about the proper use of misoprostol for labor induction before initiating therapy. One alternative to directly inserting the tablet is to pulverize it and mix with a gel such as hydroxyethylcellulose gel. However, such compounding introduces the same problems with stability and uniformity of dose as experienced with dinoprostone gels. Despite the success of misoprostol in clinical trials, it is not approved for this indication, and the manufacturer of Cytotec does not plan to pursue approval. Therefore, independent, large-scale studies are warranted to more accurately assess the efficacy and overall safety of using intravaginal alprostadil for cervical ripening and labor induction. Additional clinical experience should also help to determine the best regimen and method of administration. From the data currently available, it appears that either a 25- or 50-microgram dose (one-fourth or one-half of a 100-microgram tablet) inserted into the posterior vaginal fornix and repeated at 4-5-hour intervals if needed, is a clinically effective regimen, and is associated with the least amount of adverse effects and complications. As with all labor inductions, uterine contractions and fetal heart rate should be monitored carefully throughout the procedure.

Induction of labour versus expectant management for prelabour rupture of the membranes at term: an economic evaluation. TERMPROM Study Group. Term Prelabour Rupture of the Membranes.

BACKGROUND: As the interval between rupture of the fetal membranes at term and delivery increases, so may the risk of fetal and maternal infection. Recently the TERMPROM (Term Prelabor Rupture of the Membranes) Study Group reported the results of a randomized controlled trial comparing 4 management strategies: induction with oxytocin (IwO), induction with prostaglandin (IwP), and expectant management and induction with either oxytocin (EM-O) or prostaglandin (EM-P) if complications developed. The study found no statistically significant differences in neonatal infection and cesarean section rates between any of the 4 groups. OBJECTIVE: To conduct an economic evaluation comparing the cost of (a) IwO and EM-O, (b) IwP and EM-P and (c) IwO and IwP. DESIGN: An economic analysis, conducted alongside the clinical trial, using a third-party payer perspective. Analysis included all treatment costs incurred for both the mother and the baby. Information on health care utilization and outcomes was collected for all study participants. Three countries (Canada, the United Kingdom and Australia), corresponding to the largest study recruitment, were chosen for calculation of unit costs. For each country, the base, low and high estimates of unit cost for each service item were generated. Intention-to-treat analysis. Extensive statistical and sensitivity analyses were performed. RESULTS: The median cost of IwO per patient was significantly lower statistically than that of EM-O and IwP. This result held in all 3 countries compared -$114 and -$46 in Canada, -113 Pounds and -63 Pounds in the UK, and -A$30 and -A$49 in Australia) and after an extensive sensitivity analysis. There was no statistically significant difference in median cost per patient between IwP and EM-P. CONCLUSION: Although the clinical results of the TERMPROM study did not find IwO to be preferable to the other treatment alternatives, the economic evaluation found it to be less costly. However, these cost differences, even though statistically significant, are not likely to be important in many countries. When this is the case, the authors recommend that women be offered a choice between management strategies.

Prostaglandin E2 for cervical ripening: a randomized comparison of Cervidil versus Prepidil.

OBJECTIVE: Our purpose was to compare the efficacy and safety of two standardized preparations of prostaglandin E2, Prepidil and Cervidil, for ripening of the cervix and initiation of labor. STUDY DESIGN: This was a prospective randomized study. Subjects in whom induction of labor was indicated were randomly assigned to receive either Prepidil (n = 36), an intracervical prostaglandin E2 gel, or Cervidil (n = 37), a controlled-release hydrogel pessary, as a cervical ripening agent. Inclusion criteria included (1) a Bishop score of < or = 7, (2) a cervix < 4 cm dilated, and (3) < or = 2 cm of cervical dilatation if effacement was > 70%. Each agent was administered according to the manufacturer's recommendations. RESULTS: There was no difference in Bishop scores between the two groups at the completion of the ripening process. The following mean times were shorter for the pessary group than for the gel group: (1) insertion of the ripening agent to vaginal delivery (20.6 vs 26.4 hours, p = 0.017), (2) time to achieve cervical ripening (11.1 vs 15.2 hours, p < 0.001), (3) time to achieve active labor (18.3 vs 25.5 hours, p = 0.019), and (4) hospital stay (3.7 vs 4.4 days, p = 0.03). Labor was initiated without the use of oxytocin in 24% of patients in the pessary group versus 3% of those in the gel group (p = 0.014). CONCLUSION: Both prostaglandin E2 agents are effective in achieving cervical ripening; however, the controlled-release pessary achieves ripening over a shorter time period. Furthermore, because time to achieve vaginal delivery and length of stay are shorter, the use of oxytocin is less frequent, and there is no increase in complications, the overall cost is expected to be less with the use of Cervidil as compared with Prepidil.

Randomised trial of one versus two doses of prostaglandin E2 for induction of labour: 2. Analysis of cost.

OBJECTIVE: To compare the impact upon maternity unit resources and finances of two protocols for induction of labour using prostaglandins. DESIGN: A prospective randomised trial comparing a single dose of prostaglandin E2 (2 mg) in the evening with two doses of prostaglandin E2 (2 mg), the second being given after six hours if labour had not started or the cervix was still unripe, followed if necessary by formal induction of labour by amniotomy and oxytocin infusion 14 to 20 hours after the initial prostaglandin E2 dose. Outcome for nulliparae and multiparae were analysed separately, by treatment intention. SETTING: A maternity unit in a district general hospital delivering > 6000 women annually. PARTICIPANTS: Nine hundred and fifty-five women with viable singleton pregnancies and cephalic presentation at term without previous history of caesarean section who were advised to have labour induced with prostaglandins. MAIN OUTCOME MEASURES: Costs incurred in managing all aspects of labour, including time spent on the antenatal ward and, in the delivery unit; costs associated with formal induction, augmentation of labour and epidural analgesia; costs of intrapartum maternal morbidity, mode of delivery and immediate neonatal care. Costs of postpartum hospital stay were estimated from unit statistics. RESULTS: The overall mean cost of induction of labour was Pounds 5.00 and Pounds 7.22 less per woman for nulliparae and multiparae, respectively, if the two dose regimen was used. The main reason for the differences was due to delivery suite costs from the slightly greater rate of assisted deliveries in the single treatment groups. In contrast, costs for neonatal care were marginally lower if only one prostaglandin dose was used. CONCLUSIONS: The increased drug costs providing two prostaglandin E2 doses when required were off-set by reductions in the costs of other intrapartum interventions for both nulliparae and multiparae. The advantages of less time spent on the antenatal ward for multiparae when two prostaglandin E2 doses were used may be eliminated if amniotomy and oxytocin infusion was commenced six hours after the initial prostaglandin dose had been given if labour had not started.

Second trimester pregnancy termination including fetal death: comparison of five different methods.

OBJECTIVE: To compare the efficacy of methods for second trimester pregnancy termination. METHODS: A prospective randomized study of women undergoing pregnancy termination between 14 and 28 weeks gestation. Three hundred and forty patients with poor cervical condition (Bishop score < or = 4) in whom one of five termination methods were used were assessed: (i) extraamniotic administration of ethacridine lactate (82 patients); (ii) intracervical prostaglandin (PG) E2 gel (100 patients); (iii) intravenous infusion of concentrated oxytocin (36 patients); (iv) vaginal misoprostol (49 patients); and (v) balloon insertion (73 patients). Oxytocin infusion was used in all but concentrated oxytocin group to augment labor, when necessary. Patients in whom effective uterine contractions and cervical dilatation was not obtained within 48 h with the primary termination method were registered as failures. RESULTS: The efficacy of each method were evaluated in terms of abortion within time. Abortion within 48 h were achieved in 98.8% (81/82) of the patients in ethacridine group; 97.3% (35/36) of the patients in concentrated oxytocin group; 90.0% (90/100) of the patients in PGE2 group; 97.2% (71/73) of the patients in balloon group; 77.5% (38/49) of the patients in misoprostol group (P = 0.000, P < 0.01, Wilcoxon (Gehan) statistic). The overall median induction-abortion interval +/- S.D. (in h) in each group were as follows: ethacridine lactate: 15.7 +/- 9.6, PGE2 gel: 20.0 +/- 14.5, concentrated oxytocin: 12.2 +/- 14.4, misoprostol: 24.0 +/- 22.2, balloon: 16.0 +/- 15.4 (one way ANOVA, P = 0.003, P < 0.01). CONCLUSION: In comparison with the five methods, the use of extraamniotic ethacridine, intravenous concentrated oxytocin, and balloon was found to provide more effective treatment than intracervical PGE2 and misoprostol in terms of achievement of abortion within 24 and 48 h.

PIP: The efficacy of 5 methods of second-trimester pregnancy termination was compared in a prospective, randomized study of 340 women admitted to a High Risk Pregnancy Unit in Ankara, Turkey, with an unfavorable cervical state. The women were between 14 and 28 weeks' gestation. Termination methods assessed included: extra-amniotic administration of ethacridine lactate (82 women), cervical ripening through use of prostaglandin (PG) E2 gel (100 women), intravenous infusion of concentrated oxytocin (36 women), intravaginal misoprostol (49 women), and balloon insertion (73 women). Oxytocin infusion was used to augment labor, where necessary, in all but the concentrated oxytocin group. The main indications for pregnancy termination were fetal death (50%) and fetal anomaly (25%). Abortion within 48 hours was achieved in 98.8% of women in the ethacridine group, 97.3% of those in the concentrated oxytocin group, 90.0% of women in the PGE2 group, 97.2% of patients in the balloon group, and 77.5% of those in the misoprostol group. The median induction-abortion intervals were: ethacridine lactate, 15.7 +or- 9.6 hours; PGE2 gel, 20.0 +or- 14.5 hours; concentrated oxytocin, 12.2 +or- 14.4 hours; misoprostol, 24.0 +or- 22.2 hours; and balloon, 16.0 +or- 15.4 hours. Overall, these results suggest that mid-trimester induced abortion with extraamniotic ethacridine, balloon application, or intravenous concentrated oxytocin are the most effective techniques and should be considered as alternatives to misoprostol and PGE2.