Abstract Study question In women with unexplained infertility, does tubal flushing with oil-based contrast during HSG early in the fertility work-up reduce time to ongoing pregnancy? Summary answer In women with unexplained infertility, tubal flushing with oil-based contrast during HSG early in the fertility work-up does not reduce time to pregnancy. What is known already In couples with unexplained infertility, tubal flushing with oil-based contrast during HSG is known to increase live births and reduce time to pregnancy compared to HSG with water-based contrast. It is unknown whether tubal flushing with oil-based contrast incorporated early in the fertility work-up will have this effect as compared to 6 months later in the fertility work-up. Study design, size, duration Between August 2019 and May 2023, we performed a multicenter, randomized trial in 15 Dutch hospitals. After informed consent, participating women were randomized to immediate HSG (oil-based contrast) or HSG delayed by six months. This allowed us to assess the effect of tubal flushing versus no tubal flushing over a 6-month period, as well as time to conception after immediate versus delayed flushing over a period of 12 months. We aimed to recruit 554 participants. Participants/materials, setting, methods We included ovulatory infertile women (18-39 years), who were advised expectant management based on a favorable prognosis for natural conception (Hunault prediction-model). The study has two primary endpoints, time to conception leading to live births (I) within 6 months, and (II) over a 12-month period. Here we report on conception within 6 months leading to ongoing pregnancy. Live birth data will be available at the 2024 ESHRE meeting. Analyses were done according to intention-to-treat principle. Main results and the role of chance Between August 2019 and May 2023, we randomized 577 women (287 allocated to the immediate HSG and 290 allocated to the delayed HSG group). Mean (±sd) female age was 30.0±3.6 years and median duration of infertility was 17.0 months. In the immediate HSG group, 239 women had an HSG after a median duration of 0.7 months after randomization, while in the delayed group 83 women had an HSG within 6 months (median time to HSG: 5.2 months after randomization). Conception leading to ongoing pregnancy within 6 months occurred in 90 women (32.5%) in the immediate HSG group and 91 women (33.2%) in the delayed HSG group (HR: 0.96; 95% CI: 0.72-1.29). Conception leading to any pregnancy within 6 months occurred in 119 women (43.0%) in the immediate HSG group and 104 women (38%) in the delayed HSG group (HR: 1.16; 95% CI: 0.89-1.51). The median time to conception leading to ongoing pregnancy was 2.4 months in the immediate HSG group and also 2.4 months in in the delayed HSG group. Limitations, reasons for caution This study was limited to women with unexplained infertility with favorable natural conception chances (>30%). In this abstract, we only report time to ongoing pregnancy and not time to pregnancy leading to live birth. Data on conception leading to live births will be available at the 2024 ESHRE meeting. Wider implications of the findings In women with unexplained infertility and a favorable prognosis to conceive, early tubal flushing with oil-based contrast during HSG does not increase live birth rates nor reduce time to pregnancy within six months as compared to tubal flushing delayed by six months. Trial registration number EU clinical Trials Register, no: 2018-004153-25 AND Clinicaltrials.gov, ID: NCT05608590

In women with unexplained infertility, tubal flushing with oil-based contrast during hysterosalpingography leads to significantly more live births as compared to tubal flushing with water-based contrast during hysterosalpingography. However, it is unknown whether incorporating tubal flushing with oil-based contrast in the initial fertility work-up results to a reduced time to conception leading to live birth when compared to delayed tubal flushing that is performed six months after the initial fertility work-up. We also aim to evaluate the effectiveness of tubal flushing with oil-based contrast during hysterosalpingography versus no tubal flushing in the first six months of the study. This study will be an investigator-initiated, open-label, international, multicenter, randomized controlled trial with a planned economic analysis alongside the study. Infertile women between 18 and 39 years of age, who have an ovulatory cycle, who are at low risk for tubal pathology and have been advised expectant management for at least six months (based on the Hunault prediction score) will be included in this study. Eligible women will be randomly allocated (1:1) to immediate tubal flushing (intervention) versus delayed tubal flushing (control group) by using web-based block randomization stratified per study center. The primary outcome is time to conception leading to live birth with conception within twelve months after randomization. We assess the cumulative conception rate at six and twelve months as two co-primary outcomes. Secondary outcomes include ongoing pregnancy rate, live birth rate, miscarriage rate, ectopic pregnancy rate, number of complications, procedural pain score and cost-effectiveness. To demonstrate or refute a shorter time to pregnancy of three months with a power of 90

STUDY QUESTION:Does pain or volume of used contrast medium impact the effectiveness of oil-based contrast during hysterosalpingography (HSG)? SUMMARY ANSWER:In women who report moderate to severe pain during HSG, the use of oil-based contrast resulted in more ongoing pregnancies compared to the use of water-based contrast, whereas in women who reported mild or no pain, no difference in ongoing pregnancies was found. WHAT IS KNOWN ALREADY:We recently showed that in infertile women undergoing HSG, the use of oil-based contrast results in more ongoing pregnancies within 6 months as compared to the use of water-based contrast. However, the underlying mechanism of this fertility-enhancing effect remains unclear. STUDY DESIGN, SIZE, DURATION:We performed a post-hoc analysis of the H2Oil study, a multicentre randomised controlled trial (RCT) evaluating the therapeutic effect of oil- and water-based contrast at HSG. Here, we evaluated the impact of pain experienced at HSG and volume of used contrast media during HSG on ongoing pregnancy. PARTICIPANTS/MATERIALS, SETTING, METHODS:In a subset of 400 participating women, pain during HSG by means of the Visual Analogue Scale (VAS) (range: 0.0-10.0 cm) was reported, while in 512 women, we registered the volume of used contrast (in millilitres). We used logistic regression analyses to assess whether pain and volume of used contrast media modified the effect of oil-based contrast on ongoing pregnancy rates. Data were analysed according to intention-to-treat principle. MAIN RESULTS AND THE ROLE OF CHANCE:In 400 women in whom pain scores were reported, the overall median pain score was 5.0 (Interquartile range (IQR) 3.0-6.8) (oil group (n = 199) 4.8 (IQR 3.0-6.4); water group (n = 201) 5.0 (IQR 3.0-6.7); P-value 0.28). There was a significant interaction between pain (VAS ≤5 versus VAS ≥6) and the primary outcome ongoing pregnancy (P-value 0.047). In women experiencing pain (VAS ≥6), HSG with oil-based contrast resulted in better 6-month ongoing pregnancy rates compared to HSG with water-based contrast (49.4% versus 29.6%; RR 1.7; 95% CI, 1.1-2.5), while in women with a pain score ≤5, 6-month ongoing pregnancy rates were not significantly different between the use of oil- (28.8%) versus water-based contrast (29.2%) (RR 0.99; 95% CI, 0.66-1.5). In the 512 women in whom we recorded contrast, median volume was 9.0 ml (IQR 5.7-15.0) in the oil group versus 8.0 ml (IQR 5.9-13.0) in the water group, respectively (P-value 0.72). Volume of used contrast was not found to modify the effect of oil-based contrast on ongoing pregnancy (P-value for interaction 0.23). LIMITATIONS, REASONS FOR CAUTION:This was a post-hoc analysis that should be considered as hypothesis generating. The RCT was restricted to infertile ovulatory women, younger than 39 years of age and with a low risk for tubal pathology. Therefore, our results should not be generalised to infertile women who do not share these features. WIDER IMPLICATIONS OF THE FINDINGS:The underlying mechanism of the fertility-enhancing effect induced by HSG with the use of oil-based contrast remains unclear. However, these findings suggest a possible mechanistic pathway, that is increasing intrauterine pressure occurring prior to dislodging pregnancy hindering debris or mucus plugs from the proximal part of otherwise normal fallopian tubes. This information might help in the search of the underlying fertility-enhancing mechanism found by using oil-based contrast during HSG. STUDY FUNDING/COMPETING INTEREST(S):The original H2Oil RCT was an investigator-initiated study that was funded by the two academic institutions (AMC and VUmc) of the Amsterdam UMC. The funders had no role in study design, collection, analysis and interpretation of the data. K.D. reports consultancy for Guerbet. H.V. reports consultancy fees from Ferring. C.B.L. reports speakers' fees from Ferring and research grants from Ferring, Merck and Guerbet. V.M. reports receiving travel and speakers fees as well as research grants from Guerbet. B.W.M. is supported by an NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. The other authors do not report conflict of interests. TRIAL REGISTRATION NUMBER:The H2Oil study was registered at the Netherlands Trial Registry (NTR 3270). TRIAL REGISTRATION DATE:1 February 2012. DATE OF FIRST PATIENT’S ENROLMENT:3 February 2012.

STUDY QUESTION Are six cycles of ovulation induction with gonadotrophins more cost-effective than six cycles of ovulation induction with clomiphene citrate (CC) with or without IUI in normogonadotropic anovulatory women not pregnant after six ovulatory cycles with CC? SUMMARY ANSWER Both gonadotrophins and IUI are more expensive when compared with CC and intercourse, and gonadotrophins are more effective than CC. WHAT IS KNOWN ALREADY In women with normogonadotropic anovulation who ovulate but do not conceive after six cycles with CC, medication is usually switched to gonadotrophins, with or without IUI. The cost-effectiveness of these changes in policy is unknown. STUDY DESIGN, SIZE, DURATION We performed an economic evaluation of ovulation induction with gonadotrophins compared with CC with or without IUI in a two-by-two factorial multicentre randomized controlled trial in normogonadotropic anovulatory women not pregnant after six ovulatory cycles with CC. Between December 2008 and December 2015 women were allocated to six cycles with gonadotrophins plus IUI, six cycles with gonadotrophins plus intercourse, six cycles with CC plus IUI or six cycles with CC plus intercourse. The primary outcome was conception leading to a live birth achieved within 8 months of randomization. PARTICIPANTS/MATERIALS, SETTING, METHODS We performed a cost-effectiveness analysis on direct medical costs. We calculated the direct medical costs of ovulation induction with gonadotrophins versus CC and of IUI versus intercourse in six subsequent cycles. We included costs of medication, cycle monitoring, interventions, and pregnancy leading to live birth. Resource use was collected from the case report forms and unit costs were derived from various sources. We calculated incremental cost-effectiveness ratios (ICER) for gonadotrophins compared to CC and for IUI compared to intercourse. We used non-parametric bootstrap resampling to investigate the effect of uncertainty in our estimates. The analysis was performed according to the intention-to-treat principle. MAIN RESULTS AND THE ROLE OF CHANCE We allocated 666 women in total to gonadotrophins and IUI (n = 166), gonadotrophins and intercourse (n = 165), CC and IUI (n = 163), or CC and intercourse (n = 172). Mean direct medical costs per woman receiving gonadotrophins or CC were €4495 versus €3006 (cost difference of €1475 (95% CI: €1457-€1493)). Live birth rates were 52% in women allocated to gonadotrophins and 41% in those allocated to CC (relative risk (RR) 1.24:95% CI: 1.05-1.46). The ICER was €15 258 (95% CI: €8721 to €63 654) per additional live birth with gonadotrophins. Mean direct medical costs per woman allocated to IUI or intercourse were €4497 versus €3005 (cost difference of €1510 (95% CI: €1492-€1529)). Live birth rates were 49% in women allocated to IUI and 43% in those allocated to intercourse (RR = 1.14:95% CI: 0.97-1.35). The ICER was €24 361 (95% CI: €-11 290 to €85 172) per additional live birth with IUI. LIMITATIONS, REASONS FOR CAUTION We allowed participating hospitals to use their local protocols for ovulation induction and IUI, which may have led to variation in costs, but which increases generalizability. Indirect costs generated by transportation or productivity loss were not included. We did not evaluate letrozole, which is potentially more effective than CC. WIDER IMPLICATIONS OF THE FINDINGS Gonadotrophins are more effective, but more expensive than CC, therefore, the use of gonadotrophins in women with normogonadotropic anovulation who have not conceived after six ovulatory CC cycles depends on society's willingness to pay for an additional child. In view of the uncertainty around the cost-effectiveness estimate of IUI, these data are not sufficient to make recommendations on the use of IUI in these women. In countries where ovulation induction regimens are reimbursed, policy makers and health care professionals may use our results in their guidelines. STUDY FUNDING/COMPETING INTEREST(S) This trial was funded by the Netherlands Organization for Health Research and Development (ZonMw number: 80-82310-97-12067). The Eudract number for this trial is 2008-006171-73. The Sponsor's Protocol Code Number is P08-40. CBLA reports unrestricted grant support from Merck and Ferring. BWM is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for Merck, ObsEva and Guerbet. TRIAL REGISTRATION NUMBER NTR1449.

BACKGROUND: Laparoscopy has been claimed to be superior to hysterosalpingography (HSG) in predicting fertility. Whether this conclusion is applicable to a general subfertile population can be questioned as data in support of this claim were collected in third line centres. The aim of this study was to assess the prognostic capacity of HSG and laparoscopy in a general subfertile population.METHODS: In 38 centres, we prospectively studied a cohort of patients referred for subfertility between 2002 and 2004, who underwent HSG and/or laparoscopy as part of their subfertility work-up. Follow-up started immediately after tubal testing and ended 12 months thereafter. Time to pregnancy was censored at the of date last contact, when the woman was not pregnant or at the start of treatment. Kaplan-Meier curves for the occurrence of spontaneous intrauterine pregnancy were constructed for patients without tubal pathology, for those with unilateral tubal pathology and for patients with bilateral tubal pathology at HSG or laparoscopy. Multivariable Cox regression analysis was used to calculate fecundity rate ratios (FRRs) to express associations between tubal pathology and the occurrence of an intrauterine pregnancy.RESULTS: Of the 3301 included patients, 2043 underwent HSG only, 747 underwent diagnostic laparoscopy only and 511 underwent both. At HSG, 322 (13%) patients showed unilateral tubal pathology and 135 (5%) showed bilateral tubal pathology. At laparoscopy, 167 (13%) showed unilateral tubal pathology and 215 (17%) showed bilateral tubal pathology. Multivariable analysis resulted in FRRs of 0.81 [95% confidence interval (CI): 0.59-1.1] for unilateral, and 0.28 (95% CI: 0.13-0.59) for bilateral, tubal pathology at HSG. The FRRs at laparoscopy were 0.85 (95% CI: 0.47-1.52) for unilateral, and 0.24 (95% CI: 0.11-0.54) for bilateral, tubal pathology.CONCLUSIONS: Patients with unilateral tubal pathology at HSG and laparoscopy had a moderate reduction in pregnancy chances, whereas those with bilateral tubal pathology at HSG and laparoscopy had a severe reduction in pregnancy chances. This reduction was similar for HSG and laparoscopy, suggesting that HSG and laparoscopy have a comparable predictive capacity for natural conception.

Objective We have previously reported that NovaSure(R) was more effective than balloon ablation at 12 months follow up in the treatment of menorrhagia. In this paper, we report the 5-year outcome of this study. The objective was to evaluate amenorrhoea rates, hysterectomy rate, and quality of life associated with the bipolar impedance-controlled endometrial ablation technique (NovaSure) in comparison with balloon ablation technique (ThermaChoice(R)) at 5 years after administration.Design Double-blind randomised controlled trial, 2:1 randomisation NovaSure versus ThermaChoice.Setting A teaching hospital with 500 beds in the Netherlands.Population A total of 126 premenopausal women suffering from menorrhagia with a pictorial blood loss assessment count >= 150 without intracavitary abnormalities.Methods Women were randomly allocated to bipolar radiofrequency ablation and balloon ablation in a 2:1 ratio.Main outcome measures The main outcome measures were amenorrhoea rate, hysterectomies, and health-related quality of life (HRQol) as reported at 5 year follow up.Results At 5 years of follow up, the total response rate was 96% in the bipolar group and 90% in the balloon group. Amenorrhoea was reported in the bipolar group by 48% of women and in the balloon arm by 32% (relative risk 1.6 [.93-2.6]). There were eight women in the bipolar group (9.8%) and five in the balloon group (12.9%) who had undergone a hysterectomy. Furthermore, there was a significant equal improvement of HRQoL over time in both groups.Conclusions At 5 years follow up, bipolar thermal ablation was superior over balloon ablation in the treatment of menorrhagia.

The Chlamydia antibody titre (CAT) is a test used to identify subfertile couples at increased risk for tubal pathology. The usefulness of the routine performance of CAT was evaluated in a multicentre prospective cohort study, in women without regular ovulation. Consecutive couples presenting with subfertility due to an irregular menstrual cycle or amenorrhoea were included. A total of 711 women were studied, all of whom underwent CAT. Tubal status was verified in 190 of these women. Two-sided tubal pathology was found in 5% of these women, and one-sided occlusion in 10%. Of all the women in the study group, 33 (4.6%) had an abnormal CAT, of which 21 underwent further tubal testing. Tubal pathology was found in two (10%) of these 21 patients. The sensitivity and specificity of CAT were respectively 20% and 89%. Correction for verification bias increased the specificity to 96% with a drop of the sensitivity to 9%. In subfertile couples with anovulation, the performance of CAT is not useful. It is proposed that testing for tubal disease in these women is delayed until treatment with clomiphene citrate has failed.

Objective To compare the effectiveness of two second-generation ablation techniques, bipolar radio-frequency impedance-controlled endometrial ablation (NovaSure) and balloon ablation (ThermaChoice), in the treatment of menorrhagia.Design Double-blind, randomised, controlled trial.Setting A large teaching hospital with 500 beds in The Netherlands.Population Women suffering from menorrhagia referred by their general practitioner.Methods Women suffering from menorrhagia, without intracavitary abnormalities, were randomly allocated to bipolar radio-frequency ablation (bipolar group) and balloon ablation (balloon group) in a 2:1 ratio. At follow up, both women and observers were unaware of the type of treatment that had been performed.Main outcome measures The main outcome measure was amenorrhea at 3, 6 and 12 months after randomisation.Results One hundred and twenty-six women were included in the study, of which 83 were allocated to the bipolar group, and 43 to the balloon group. No complications occurred in either of the treatment groups. At the one-year follow up stage, amenorrhea rates were 43% (34/83) in the bipolar group and 8% (3/43) in the balloon group (treatment effect in time P < 0.001). At this stage, 90% of the patients in the bipolar group were satisfied with the result of the treatment against 79% in the balloon group (treatment effect in time P= 0.003).Conclusion The bipolar radio-frequency impedance-controlled endometrial ablation system is more effective than balloon ablation in the treatment of menorrhagia.

Objective: To compare health-related quality of life (HRQoL) after bipolar radio frequency ablation and thermal balloon ablation in women with dysfunctional uterine bleeding.Design: Randomized clinical trial.Setting: Teaching hospital.Patient(s): Women suffering from dysfunctional uterine bleeding.Intervention(s): Bipolar radio frequency ablation and thermal balloon ablation.Main Outcome Measure(s): Patients were asked to complete HRQoL questionnaires at baseline, and at 2 days, 2 weeks, 3 months, 6 months, and 12 months after surgery. The questionnaires contained the medical outcomes study Short-Form 36 (SF-36), the Self-rating Depression Scale, the Rotterdam Symptom Checklist, State-Trait Anxiety Inventory, and a structured clinical history questionnaire.Result(s): Data on HRQoL were available on at least two different time points in 115 and 126 randomized patients. HRQoL improved significantly over time in both groups, except for the domain of general health in the SF-36. None of the dimensions showed a significant difference between both groups, neither was there a significant interaction between time and treatment effect.Conclusion(s): Both methods significantly improved HRQoL in women with dysfunctional uterine bleeding. However, despite better amenorrhea and satisfaction rates after bipolar radio frequency ablation, there was no difference in HRQoL between the two groups. (c) 2005 by American Society for Reproductive Medicine.

Fallopian tube obstruction is thought to play a role in 12% to 33% of subfertile couples. Assessing the patency of the fallopian tubes is, therefore, an important part of the work-up of a subfertile couple. There are several tests available for this purpose, including hysterosalpingography, laparoscopy and dye test, selective salpingography and hysterosalpingo-contrast sonography (Table 1). Each one of these tests differs in interand intra-observer reliability, diagnostic accuracy to predict blockage or other tubal disease, the prognostic information for treatmentindependent pregnancy, potential complications and costs. Moreover, some of these tests would allow assessment of the possible functioning of the tubes (e.g. measurement of tubal perfusion pressures during selective salpingography), evaluation of other pelvic pathology that may have an impact on fertility (e.g. laparoscopy to assess for endometriosis) or improve pregnancy rates in their own right (e.g. oil-based hysterosalpingography). Currently, there is a wide variation in the choice, combinations and ordering of tubal evaluation tests in different assisted conception units. While there could be several reasons for such variation in practice, one reason may be a lack of collated information that allows an easy comparison of the available tests. We, therefore, reviewed tubal evaluation tests for their interand intra-observer reliability, accuracy to predict tubal blockage and disease, prognostic value for treatment-independent pregnancies, effectiveness to improve pregnancy outcome and possible complications. We limited our review to visual tests only—non-visual tests such as chlamydial antibody testing were not considered in this review.

Objective: To investigate patient preferences for endometrial ablation and a levonorgestrel-releasing intrauterine device (IUD) as alternatives to hysterectomy in the treatment of dysfunctional uterine bleeding.Design: Comparative study based on structured interviews.Setting: A large teaching hospital with 500 beds in the Netherlands.Patient(s): Ninety-six patients who were scheduled for endometrial ablation, 25 patients who were scheduled for hysterectomy, and 23 patients who were scheduled for a levonorgestrel-releasing IUD were interviewed. All of the women had dysfunctional uterine bleeding.Intervention(s): Patients were asked to state their most significant complaints and their reasons for choosing a particular treatment. Subsequently, the preference for endometrial ablation and a levonorgestrel-releasing IUD as alternatives to hysterectomy was assessed during a structured interview. Women were informed about the advantages and disadvantages of all three treatment options. Patients rated their preferences according to different hypothetical success rates. The success rates after endometrial ablation and levonorgestrel-releasing IUD were varied until patients found an acceptable treatment outcome.Main Outcome Measure(s): Patient preference of endometrial ablation and the levonorgestrel-releasing IUD over hysterectomy.Result(s): The main reason for the treatment of choice differed between the three groups. Most of the patients in the hysterectomy group wanted a definite solution to their problems, whereas patients in the levonorgestrel-releasing IUD group and in the ablation group put greater emphasis on a minimally invasive intervention with or without a short hospital stay. In women undergoing ablation, 70% of the patients preferred this treatment and the levonorgestrel-releasing IUD to hysterectomy in cases in which the success rate of noninvasive treatment was presumed to be 50%. In women having a levonorgestrel-releasing IUD inserted, 95% of the patients preferred this approach over hysterectomy in cases in which the success rate of this device was presumed to be 50%, whereas 35% of patients prefer-red ablation over hysterectomy in cases in which the success rate of ablation was presumed to be 50%. In women undergoing hysterectomy, 30% would have opted for ablation and 45% would have opted for a levonorgestrel-releasing IUD in cases in which success rates were 50%. Of patients who opted for hysterectomy, however, 60% stated that they would have preferred a noninvasive treatment if the success rate of this type of treatment were >80%.Conclusion(s): A majority of the patients who had dysfunctional uterine bleeding and who were scheduled for an endometrial ablation or a levonorgestrel-releasing IUD were inclined to take a risk of 50% likelihood of treatment failure to avoid a hysterectomy. As a consequence, research of treatment for dysfunctional uterine bleeding should focus on this 50% success level. (Fertil Steril(R) 2004;82:160-6. (C)2004 by American Society for Reproductive Medicine.)

OBJECTIVE:To compare maternal and perinatal complications in triplet and twin pregnancies.STUDY DESIGN:Case-controlled study in the setting of a University Hospital. Each pregnancy of a consecutive series of 40 triplet pregnancies of 20 weeks or more was matched for parity and maternal age with two sets of twins delivered in the same year. Primary end points of the analysis were maternal complications and perinatal outcome.RESULTS:Of the triplets 82% and of the twins 36% were a result of assisted reproduction. Pre-term labor occurred significantly more often in triplet than in twin gestation. Triplets had a significantly lower median birth-weight (1478 vs. 2030 g) and gestational age at delivery (32 vs. 35.5 weeks). The mean neonatal hospital stay was significantly longer in triplets, mainly related to the lower birth-weight, but there was no significant difference between triplets and twins in the incidence of major neonatal complications.CONCLUSION:This data of the anticipated perinatal outcome in triplet and twin pregnancies may be used to counsel women with a triplet pregnancy considering selective reduction to twins. All methods of assisted reproduction should aim at prevention of multifetal gestation.

We compared the effects of continuous epidural infusion of ropivacaine 0.25% with bupivacaine 0.25% on pain relief and motor block during labor, and on the neonate. Seventy-six full-term parturients in active labor requiring epidural analgesia were randomly allocated to receive either bupivacaine 0.25% or ropivacaine 0.25%. Fifteen minutes after a loading dose of 10 mL of the study drug, an epidural infusion with the same drug was started at 6-12 mL/h to maintain an adequate block. Top-up doses of 6-10 mL were given as required. At full cervical dilation, the epidural infusion was discontinued. The onset of pain relief (verbal scale), contraction pain (visual analog scale), intensity of motor block (modified Bromage scale), and duration of motor block were not statistically different between the groups. Apgar scores at 1 and 5 min after delivery were comparable. There was a higher proportion of the neonates in the ropivacaine group (26/31 = 84%) who had a neurologic and adaptive capacity score (NACS) > or = 35 2 h after delivery than in the bupivacaine group (18/29 = 62%). We conclude that ropivacaine 0.25% and bupivacaine 0.25% are equally effective for epidural pain relief during labor. Ropivacaine may have an advantage over bupivacaine regarding neonatal neurobehavioral performance during the first few hours after delivery, although further studies will be required to substantiate this.