An economic evaluation of planned immediate versus delayed birth for preterm prelabour rupture of membranes: findings from the PPROMT randomised controlled trial.

OBJECTIVE: This study is an economic evaluation of immediate birth compared with expectant management in women with preterm prelabour rupture of the membranes near term (PPROMT). DESIGN: A cost-effectiveness analysis alongside the PPROMT randomised controlled trial. SETTING: Obstetric departments in 65 hospitals across 11 countries. POPULATION: Women with a singleton pregnancy with ruptured membranes between 34+0 and 36+6 weeks gestation. METHODS: Women were randomly allocated to immediate birth or expectant management. Costs to the health system were identified and valued. National hospital costing data from both the UK and Australia were used. Average cost per recruit in each arm was calculated and 95% confidence intervals were estimated using bootstrap re-sampling. Averages costs during antenatal care, delivery and postnatal care, and by country were estimated. MAIN OUTCOMES MEASURES: Total mean cost difference between immediate birth and expectant management arms of the trial. RESULTS: From 11 countries 923 women were randomised to immediate birth and 912 were randomised to expectant management. Total mean costs per recruit were £8852 for immediate birth and £8740 for expectant delivery resulting in a mean difference in costs of £112 (95% CI: -431 to 662). The expectant management arm had significantly higher antenatal costs, whereas the immediate birth arm had significantly higher delivery and neonatal costs. There was large variation between total mean costs by country. CONCLUSION: This economic evaluation found no evidence that expectant management was more or less costly than immediate birth. Outpatient management may offer opportunities for cost savings for those women with delayed delivery. TWEETABLE ABSTRACT: For women with preterm prelabour rupture of the membranes, the relative benefits and harms of immediate and expectant management should inform counselling as costs are similar.

[Ambulant Management in Case of Premature Rupture of Membranes (PROM) at Term: Maternal and Perinatal Outcome]. / Ambulantes Management bei vorzeitigem Blasensprung (VBS) am Termin. Eine Outcome-Analysestudie bei ambulantem vs. stationärem Management.

Introduction: It is estimated that after premature rupture of membranes (PROM) at term, 60% of all women go into labour within 48 h, 95% within 72 h. Often labour is induced after 24 h because the risk of maternal and neonatal infection rises. The majority of clinicians advise hospital care to allow monitoring and detection of problems. But for low-risk patients who meet strict inclusion criteria, sometimes home management is possible. This study examines the safety and costs of home management. Material and Methods: We included 239 patients with PROM at term, 202 of them with hospital and 37 with home management. Patients who met the inclusion criteria were checked 12 h after PROM and were induced by the end of 24 h if labour had not begun spontaneously. Results: There were no differences in maternal or neonatal outcome. Women with home management were likely to spend less time in hospital and this was associated with reduced costs. Conclusion: Women with outpatient management of PROM had a shorter hospitalization stay without negative impact on maternal or fetal outcome. In times of increasing financial pressure on the medical system, outpatient management for PROM seems to be a viable option.

Economic analysis comparing induction of labor and expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks (PPROMEXIL trial).

OBJECTIVE: To compare the costs of induction of labor and expectant management in women with preterm prelabor rupture of membranes (PPROM). DESIGN: Economic analysis based on a randomized clinical trial. SETTING: Obstetric departments of eight academic and 52 non-academic hospitals in the Netherlands. POPULATION: Women with PPROM near term who were not in labor 24 h after PPROM. METHODS: A cost-minimization analysis was done from a health care provider perspective, using a bottom-up approach to estimate resource utilization, valued with unit-costs reflecting actual costs. MAIN OUTCOME MEASURES: Primary health outcome was the incidence of neonatal sepsis. Direct medical costs were estimated from start of randomization to hospital discharge of mother and child. RESULTS: Induction of labor did not significantly reduce the probability of neonatal sepsis [2.6% vs. 4.1%, relative risk 0.64 (95% confidence interval 0.25-1.6)]. Mean costs per woman were €8094 for induction and €7340 for expectant management (difference €754; 95% confidence interval -335 to 1802). This difference predominantly originated in the postpartum period, where the mean costs were €5669 for induction vs. €4801 for expectant management. Delivery costs were higher in women allocated to induction than in women allocated to expectant management (€1777 vs. €1153 per woman). Antepartum costs in the expectant management group were higher because of longer antepartum maternal stays in hospital. CONCLUSIONS: In women with pregnancies complicated by PPROM near term, induction of labor does not reduce neonatal sepsis, whereas costs associated with this strategy are probably higher.

Pregnancy outcomes after treatment for cervical intraepithelial neoplasia in a single NHS hospital.

OBJECTIVE: The objective of this study was to assess the adverse pregnancy outcomes in women who had treatment for cervical intraepithelial neoplasia. METHODS: This was a retrospective cohort using data linkage. Pathology databases from Whipps Cross University Hospital were used to identify women with a histological sample taken at colposcopy between 1995 and 2009. Births for these women were identified through the hospitals' obstetric database. A total of 876 births (from 721 women) were identified. Logistic regression was used to assess the relationship between adverse pregnancy outcomes and treatment for cervical intraepithelial neoplasia before delivery. Results were adjusted by ethnicity, deprivation, and parity. RESULTS: After taking into account parity, socioeconomic status, and ethnicity, receiving any type of excisional treatment (single or multiple) before birth increased the risk of preterm labor compared with having a punch biopsy only (adjusted relative risk, 1.61; 95% confidence interval, 1.11-2.32). Preterm deliveries that occurred after a spontaneous onset of labor were found to be more likely after treatment for cervical disease (adjusted relative risk, 1.68; 95% confidence interval, 1.11-2.52). CONCLUSIONS: Women receiving any type of excisional treatment before delivery are at increased risk of preterm delivery when compared with women attending colposcopy but not treated. Although we took into account the effects of parity, socioeconomic status, and ethnicity, residual confounding factors may be unidentified.

Magnesium sulfate therapy for the prevention of cerebral palsy in preterm infants: a decision-analytic and economic analysis.

OBJECTIVE: We sought to estimate the cost-effectiveness of magnesium neuroprophylaxis for all women at risk for preterm birth <32 weeks. STUDY DESIGN: A decision analytic and cost-effectiveness model was designed to compare use of magnesium for neuroprophylaxis vs no treatment for women at risk for preterm birth <32 weeks due to preterm premature rupture of membranes or preterm labor from 24-32 weeks. Outcomes included neonatal death and moderate-severe cerebral palsy. Effectiveness was reported in quality-adjusted life years. RESULTS: Magnesium for neuroprophylaxis led to lower costs ($1739 vs $1917) and better outcomes (56.684 vs 56.678 quality-adjusted life years). However, sensitivity analysis revealed the model to be sensitive to estimates of effect of magnesium on risk of moderate or severe cerebral palsy as well as neonatal death. CONCLUSION: Based on currently published evidence for efficacy, magnesium for neuroprophylaxis in women at risk to deliver preterm is cost-effective.

Comparison of Childbirth Delivery Outcomes and Costs of Care Between Women Experiencing vs Not Experiencing Homelessness.

Importance: Women and families constitute the fastest-growing segments of the homeless population. However, there is limited evidence on whether women experiencing homelessness have poorer childbirth delivery outcomes and higher costs of care compared with women not experiencing homelessness. Objective: To compare childbirth delivery outcomes and costs of care between pregnant women experiencing homelessness vs those not experiencing homelessness. Design, Setting, and Participants: This cross-sectional study included 15 029 pregnant women experiencing homelessness and 308 242 pregnant women not experiencing homelessness who had a delivery hospitalization in 2014. The study used statewide databases that included all hospital admissions in 3 states (ie, Florida, Massachusetts, and New York). Delivery outcomes and delivery-associated costs were compared between pregnant women experiencing homelessness and those not experiencing homelessness cared for at the same hospital (analyzed using the overlap propensity-score weighting method and multivariable regression models with hospital fixed effects). The Benjamini-Hochberg false discovery rate procedure was used to account for multiple comparisons. Data were analyzed from January 2020 through May 2020. Exposure: Housing status at delivery hospitalization. Main Outcomes and Measures: Outcome variables included obstetric complications (ie, antepartum hemorrhage, placental abnormalities, premature rupture of the membranes, preterm labor, and postpartum hemorrhage), neonatal complications (ie, fetal distress, fetal growth restriction, and stillbirth), delivery method (ie, cesarean delivery), and delivery-associated costs. Results: Among 15 029 pregnant women experiencing homelessness (mean [SD] age, 28.5 [5.9] years) compared with 308 242 pregnant women not experiencing homelessness (mean [SD] age, 29.4 [5.8] years) within the same hospital, those experiencing homelessness were more likely to experience preterm labor (adjusted probability, 10.5% vs 6.7%; adjusted risk difference [aRD], 3.8%; 95% CI, 1.2%-6.5%; adjusted P = .03) and had higher delivery-associated costs (adjusted costs, $6306 vs $5888; aRD, $417; 95% CI, $156-$680; adjusted P = .02) compared with women not experiencing homelessness. Those experiencing homelessness also had a higher probability of placental abnormalities (adjusted probability, 4.0% vs 2.0%; aRD, 1.9%; 95% CI, 0.4%-3.5%; adjusted P = .053), although this difference was not statistically significant. Conclusions and Relevance: This study found that women experiencing homelessness, compared with those not experiencing homelessness, who had a delivery and were admitted to the same hospital were more likely to experience preterm labor and incurred higher delivery-associated costs. These findings suggest wide disparities in delivery-associated outcomes between women experiencing homelessness and those not experiencing homelessness in the US. The findings highlight the importance for health care professionals to actively screen pregnant women for homelessness during prenatal care visits and coordinate their care with community health programs and social housing programs to make sure their health care needs are met.

Induction of labour versus expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks (the PPROMEXIL-trial).

BACKGROUND: Preterm prelabour rupture of the membranes (PPROM) is an important clinical problem and a dilemma for the gynaecologist. On the one hand, awaiting spontaneous labour increases the probability of infectious disease for both mother and child, whereas on the other hand induction of labour leads to preterm birth with an increase in neonatal morbidity (e.g., respiratory distress syndrome (RDS)) and a possible rise in the number of instrumental deliveries. METHODS/DESIGN: We aim to determine the effectiveness and cost-effectiveness of immediate delivery after PPROM in near term gestation compared to expectant management. Pregnant women with preterm prelabour rupture of the membranes at a gestational age from 34+0 weeks until 37+0 weeks will be included in a multicentre prospective randomised controlled trial. We will compare early delivery with expectant monitoring. The primary outcome of this study is neonatal sepsis. Secondary outcome measures are maternal morbidity (chorioamnionitis, puerperal sepsis) and neonatal disease, instrumental delivery rate, maternal quality of life, maternal preferences and costs. We anticipate that a reduction of neonatal infection from 7.5% to 2.5% after induction will outweigh an increase in RDS and additional costs due to admission of the child due to prematurity. Under these assumptions, we aim to randomly allocate 520 women to two groups of 260 women each. Analysis will be by intention to treat. Additionally a cost-effectiveness analysis will be performed to evaluate if the cost related to early delivery will outweigh those of expectant management. Long term outcomes will be evaluated using modelling. DISCUSSION: This trial will provide evidence as to whether induction of labour after preterm prelabour rupture of membranes is an effective and cost-effective strategy to reduce the risk of neonatal sepsis. CONTROLLED CLINICAL TRIAL REGISTER: ISRCTN29313500.

Vision Amniotic Leak Detector (ALD) to Eliminate Amniotic Fluid Leakage as a Cause of Vaginal Wetness in Pregnancy: A NICE Medical Technology Guidance.

In prelabour rupture of membranes (PROM) or preterm PROM the amniotic membranes rupture prior to labour. Where this is not overt a speculum examination is undertaken to confirm diagnosis. The Vision Amniotic Leak Detector (ALD) is a panty liner that can diagnose amniotic fluid as a cause of vaginal wetness. It was evaluated by the UK National Institute for Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme. The sponsor (CommonSense Ltd) identified five studies, of which three were deemed within scope by the External Assessment Centre (EAC). Two of these three used an inappropriate comparator. The EAC recalculated the diagnostic accuracy of Vision ALD using speculum examination as the comparator: sensitivity of 97% (95% CI 93-99%), negative predictive value of 96% (95% CI 92-98%). A negative result would therefore allow patients to be discharged with confidence. In the sponsor's cost-consequence model only patients with a positive Vision ALD result would have a speculum examination, producing a cost saving of around £10 per patient. The EAC felt that some costs were unjustified and the model did not include infection outcomes or use in a community setting. The EAC revised the sponsor's model and found the results were most sensitive to clinician costs. Vision ALD was associated with savings of around £15-£25 per patient when administration in lower-cost community healthcare avoided a referral to a higher-cost secondary-care centre. NICE published guidance MTG15 in July 2013 recommending that the case for adopting Vision ALD was supported by the evidence.

Preterm premature rupture of membranes: a randomized study of home versus hospital management.

OBJECTIVE: To compare length of latency period, gestational age at delivery, and safety in a carefully selected group of patients with preterm premature rupture of the membranes (PROM) randomized to home versus hospital management. METHODS: After meeting strict inclusion criteria, 67 patients with preterm PROM were randomized by sealed envelope to home versus hospital expectant management. The groups were managed similarly with pelvic and bed rest. Management included recording of temperature and pulse every 6 hours, daily charting of fetal movements, twice-weekly nonstress test and complete blood count, and weekly ultrasound and visual examination of the cervix. RESULTS: There was no significant difference in clinical characteristics or perinatal outcome between the groups. There was, however, a significant decrease in both the days of maternal hospitalization and maternal hospital expenses in the home group. CONCLUSION: Only a very small proportion of cases of preterm PROM (18%) could meet the strict safety criteria for inclusion used in the study. In the home-management group, length of the latency period and gestational age at delivery were not significantly different than in hospitalized patients.

Costs of maternal conditions attributable to smoking during pregnancy.

CONTEXT: Despite known adverse health effects, many women continue to smoke during pregnancy. Public attention has now focused on the economic as well as health effects of this behavior. OBJECTIVE: To estimate health care costs associated with smoking-attributable cases of placenta previa, abruptio placenta, ectopic pregnancy, preterm premature rupture of the membrane (PPROM), pre-eclampsia, and spontaneous abortion. DESIGN: Pooled odds ratios were used with data on total cases to estimate smoking-attributable cases. Estimated average costs for cases of ectopic pregnancy and spontaneous abortion were used to estimate smoking-attributable health care costs for these conditions. Incremental costs, or costs above those for a "normal" delivery, were used to estimate smoking-attributable costs of placenta previa, abruptio placenta, PPROM, and pre-eclampsia associated with delivery. SETTING: National estimates for 1993. PARTICIPANTS: Data from the National Hospital Discharge Survey (NHDS) and claims data from a sample of large, self-insured employers across the country. RESULTS: Smoking-attributable costs ranged from $1.3 million for PPROM to $86 million for ectopic pregnancy. Smoking during pregnancy apparently protects against pre-eclampsia and saves between $36 and $49 million, depending on smoking prevalence. Over all conditions smoking-attributable costs ranged from $135 to $167 million. CONCLUSIONS: Smoking during pregnancy is a preventable cause of higher health care costs for the conditions studied. While smoking during pregnancy was found to be protective against pre-eclampsia and, hence, saves costs, the net costs were still positive and significant. Effective smoking-cessation programs can reduce health care costs but clinicians will perhaps need to manage increased cases of pre-eclampsia in a cost-effective manner.

Delivery at 34 weeks is more costly than at 35 weeks in pregnancies with premature rupture of membranes.

OBJECTIVE: To assess the relative risks and costs of delivery at 34 vs. 35 weeks with preterm premature rupture of membranes (PROM). STUDY DESIGN: Retrospective study of singleton gestations with preterm PROM over a 5-year period. Patients who delivered at 34 vs. 35 weeks were compared. RESULTS: Sixty-five patients were identified in each group. There were no significant differences in maternal demographics or complications. Direct costs of mother-infant pairs at 34 weeks were significantly higher (dollars 6687 +/- 4273 vs. dollars 4089 +/- 3037, p = 0.0001). Newborn intensive care unit stay was significantly longer for infants born at 34 weeks (8.4 +/- 7.1 vs. 3.5 +/- 4.6 days, p < 0.0001). CONCLUSIONS: There was a significant increase in neonatal interventions, neonatal length of stay and cost for infants delivered at 34 vs. 35 weeks. Prospective data are necessary to evaluate the actual maternal and neonatal morbidity incurred by delay of delivery.

Pregnancy outcome after expectant management of premature rupture of the membranes in the second trimester.

Because management of premature rupture of the membranes (PROM) at or before 26 weeks is controversial, we examined maternal and perinatal outcome after expectant management of 44 pregnancies complicated by this problem. Mean gestational age at preterm PROM was 23.9 +/- 1.7 (SD) weeks. The latency period between preterm PROM and delivery ranged from 1 to 68 days, with a medium of 6. Of the patients, 54.6% delivered within a week of PROM, and 79.5% delivered by four weeks; 77.2% developed chorioamnionitis, but despite this high incidence, there was no maternal sepsis or pelvic thrombophlebitis, and no maternal surgery was necessary. Perinatal outcome was 60.5% neonatal survival, 54.2% perinatal survival and a stillbirth rate of 10.4%. Respiratory distress syndrome, bronchopulmonary dysplasia, sepsis and intraventricular hemorrhage were common types of neonatal morbidity. There was no pulmonary hypoplasia, and limb deformity was seen in only two neonates. Costs of expectant management in pregnancies complicated by second-trimester PROM were estimated, and a strategy to reduce cost is suggested.

[Maternal and fetal morbidity in patients with premature rupture of the membrane after 27-week gestation. Causes and costs]. / Condiciones atribuibles y costos de la morbilidad materno-fetal en pacientes con ruptura prematura de membranas después de las 27 semanas de gestación.

Premature rupture of the membranes (PROM) occurs in a third of the childbirths preterm, this represents 8% of all pregnancies, with same morbidity and mortality in developing and developed countries, PROM is the more common cause of neonatal morbidity and mortality, making this obstetric complication a worldwide problem of health, since it contributes to the economic problem for the cost risen in medical attention for both, mothers and live birth. PROM is considered a mutifactorial entity. This study was carried out in the Hospital de Ginecología y Obstetricia of the Centro Médico "La Raza" in Mexico City, where women entered in serial form with pregnancies from 27 to 34 weeks of gestation and spontaneous PROM, without any other pathology. 120 patients were included, with 26.8 +/- 5.9 year-old age. The gestational age with more frequency of PROM were from 30 to 33 weeks, 22.5% of the patients had 4 days with PROM, 6 of this cases arrived up to 13 days with this complication at delivery. 2.5% of the patients presented deciduitis, with adequated response to the use of antibiotics. When analyzing the hospital stay, a stay was observed from 4 to 7 days (5.26 +/- 1.96 M +/- SD), with a total cost for maternal stay of 2 millions 445,650 pesos. Those babies born had an average of 23 days of hospital stay and the total cot of the days of stay was 4 millions 963,978 pesos. Other costs were the attention of maternal and pediatrics specialty, the obstetric resolution of the pregnancy, obstetric ultrasonography and crystallographies. Thus, the total costs of the attention of this complication in these patients with PROM was of 10 millions 296,988 pesos. The international reference is the American dollar that was in 10 pesos for dollar to the moment of this study. The maternal morbidity is low to that described in previous studies, but in spite of the exhaustive efforts on the prevention, prediction, diagnosis and treatment, the premature rate due to PROM has not diminished, however the rate of neonatal survival has been increased and the morbidity has diminished.

Adverse perinatal outcomes after the February 27th 2010 Chilean earthquake.

OBJECTIVE: To investigate whether the February 27th earthquake exposition was associated to adverse perinatal outcomes in Chilean pregnant women. METHODS: We analyzed all deliveries occurred in 2009 (n = 3,609) and 2010 (n = 3,279) in a reference hospital in the area of the earthquake. Furthermore, we investigated pregnant women who gave birth between March 1st and December 31st 2010 (n = 2,553) and we classified them according to timing of exposition. RESULTS: We found a 9% reduction in birth rate, but an increase in the rate of early preterm deliveries (<34 weeks), premature rupture of membranes (PROM), macrosomia, small for gestational age, and intrauterine growth restriction (IUGR) after the earthquake, in contrast to the previous year. Women exposed to the earthquake during her first trimester delivered smaller newborns (3,340 ± 712 g v/s 3,426 ± 576 g respectively, p = 0.007) and were more likely diagnosed with early preterm delivery, preterm delivery (<37 weeks) and PROM but were less likely diagnosed with IUGR and late delivery (42 weeks, p < 0.05) compared to those exposed at third trimester. Accordingly, IUGR and preterm deliveries presented elevated healthcare costs. CONCLUSION: Natural disasters such as earthquakes are associated to adverse perinatal outcomes that impact negatively the entire maternal-neonatal healthcare system.

Premature rupture of the membranes--aggressive versus conservative approach: effect of tocolytic and antibiotic therapy.

The purpose of this randomized, prospective study was to evaluate the efficacy of tocolytic and antibiotic therapy in the prolongation of pregnancy and neonatal outcome in the treatment of premature rupture of the membranes without clinical labor. Delivery was delayed for 48 h, 7 days and beyond 35 weeks of gestation in 87, 39 and 18%, respectively, of patients in the treated group (n = 39) compared with 50, 12 and 17% of patients in the nontreated group (n = 42). The incidence of a low Apgar score (< 7 at 5 min), requiring artificial ventilation, and infectious morbidity was more common in the treated group than in the nontreated group (18 vs. 0, 41 vs. 17 and 39 vs. 17%, respectively). There was no significant cost difference in survivors between the treated and nontreated groups, although the mothers in the treated group were significantly more expensive. From these observations, it appears that tocolysis and antibiotics are not effective in PROM cases.

Management of premature rupture of membranes at or near term.

The purpose of this retrospective cohort study was to explore the safety and cost-effectiveness of conservatively managed premature rupture of the membranes (PROM) in term and near-term pregnancy. The records of 909 women with PROM at or near term were reviewed. Outcomes of those women and infants who were managed conservatively were compared with those who were managed aggressively. Those who were managed conservatively experienced one-third the rate of cesarean sections, with no increase in intrauterine or neonatal infections, and were hospitalized a half-day longer than those managed aggressively. These findings are consistent with previously published studies and support the position that conservative management can be safe for both mother and infant. The findings also confirm that, with minor adjustments in institutional protocols, conservative management can be cost-effective.

The therapeutic efficacy and cost-effectiveness of aggressive tocolysis for premature labor associated with premature rupture of the membranes.

We conducted a randomized trial comparing bed rest with tocolysis to determine the therapeutic efficacy, safety, and cost-effectiveness of tocolysis for the treatment of preterm labor after membrane rupture. One hundred nine women participated over a 26-month interval. Treatment groups did not differ significantly in terms of gestational age at membrane rupture, gestational age at delivery, birth weight, maternal or fetal infectious morbidity, respiratory distress syndrome, necrotizing enterocolitis, or perinatal mortality. Prolongation of intrauterine time after the onset of uterine contractions was seen in women receiving tocolysis (105.2 +/- 157 hours versus 62.1 +/- 77 hours, p = 0.06). This prolongation was not associated with a significant reduction in the total cost per surviving infant (tocolysis, $38,593 +/- $40,887 versus bed rest, $43,158 +/- $37,116; p = 0.445). The cost difference was artifactual. The number of very premature infants born (less than 28 weeks' gestation) was unequal in the two groups (12 in the bed rest group and 5 in the tocolysis group) and skewed the results. Before 28 weeks' gestation tocolysis was associated with a significant increase in intrauterine time after the onset of regular contractions (p = 0.05). However, there was no identifiable perinatal benefit garnered from the additional 5 days. After 28 weeks there were no significant differences between treatment groups in terms of intrauterine time after the onset of regular contractions and total cost per surviving infant. Because tocolysis does not improve perinatal outcome and can itself be associated with major maternal morbidity, it should be avoided after 28 weeks' gestation. Before 28 weeks' gestation tocolysis may greatly increase intrauterine time, but the benefit of this prolongation is not clear.

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.