Introduction: In France, performance of a termination of pregnancy is legally possible without any gestational age limit. After 22 weeks of gestation, a feticide is ethically performed using usually sufentanil and lidocaine. The aim of this study was to compare the use of remifentanil, a fast-acting morphine-derivating product, instead of sufentanil. Methods: This 2-center randomized, controlled, single-blinded phase-III treatment trial had 2 parallel arms: an experimental group using remifentanil with lidocaine versus a control group receiving sufentanil associated with lidocaine. This trial took place over a 40-month period. The primary outcome was time to fetal asystole after lidocaine injection. The secondary outcome measures were the procedure’s success rate, the rate of serious maternal side effects, and the presence of cellular or tissue modifications. Results: The study included 66 women, randomized into 2 groups of similar size and characteristics. Time to fetal asystole did not differ significantly between the groups, with a delay of 4 min (Q1−Q3, 2–11) in the sufentanil group and 4 min (Q1−Q3, 1–10) in the remifentanil group (p = 0.84). Similarly, the success rate of the procedure did not differ significantly. Fetal asystole was procured in <2 min and persisted >1 min for 16 (25.8%) women in our total population: 7 (22.5%) in the sufentanil group and 9 (29.0%) in the remifentanil group, p = 0.77. No severe maternal side effects were observed. Among the 49 fetopathological examinations performed, the few tissue and cell modifications observed did not cause any interpretation difficulties in either group. Discussion/Conclusion: Use of remifentanil instead of sufentanil for feticide procedure did not improve time to fetal asystole. No harmful effect was observed for either maternal tolerance or interpretation of the histologic slides.
Objectives In early pregnancies, miscarriages and inconclusive ultrasound scans considering location and viability are very common. In several previous studies, serum progesterone levels predicted viability of pregnancy and, in recent ones, failed Pregnancies of Unknown Location (PUL), completion of miscarriage and complications. Corpus luteum, secreting progesterone in early pregnancy, was less studied. Some publications showed correlations between corpus luteum aspects and diagnosis of miscarriage but it was not evaluated for other outcomes in early pregnancy, such as failed PUL, completion of miscarriage or complications. We aimed to assess if Doppler examination of corpus luteum could also predict all these outcomes: failed PUL, diagnosis and completion of miscarriages and complications. Study design A single operator prospectively described and/or collected pictures of Doppler signal in the wall of the corpus luteum at most consultations in our early pregnancy unit and established a three-level score. All suspected or confirmed non-viable pregnancies with this score or/and serum progesterone levels were registered retrospectively. With logistic regressions, AIC/BIC, likelihood ratios, ROC curves, Mann-Whitney and Fisher exact tests, we evaluated the ability of the score, alone, to predict failed PUL, diagnosis and completion of miscarriages and the complications, and, combined, to improve previously published predictions. Results From 277 included pregnancies, 186 (67.1 %) miscarried. Of these, 159/186 (85.5 %) fully evacuated without surgery: 114/186 (61.3 %) within 20 days after the first diagnosis and 45/186 (24.2 %) after more than 20 days. Twenty-seven patients (14.5 %) underwent surgical evacuation, including ten complications, five haemorrhages and five suspected infections. Logistic regression correlated strongly the corpus luteum score with failed PUL (p < 0.0001) and miscarriages (p < 0.0001). Moreover, rates of complications and swift non-surgical completions of miscarriage were respectively 0 % and 92 % with scores of 0, versus 6 % and 44 % with scores of 1, versus 16 % and 0 % with scores of 2. Combined with serum progesterone levels, this score improved most predictions. Adding parity or history of miscarriage in predictive models even increased these performances. Conclusions Corpus luteum score, alone, can predict failed PUL, diagnosis and completion of miscarriages and their complications. Combining this score with other factors (mainly serum progesterone levels) improves most predictions.
In France, termination of pregnancy (TOP) can be performed regardless of gestational age if the fetus is at high risk for a severe and uncorrectable condition or the mother's health is compromised, and there is medical approval. After 22 weeks of gestation, feticide is legally and ethically required before terminating the pregnancy1. We performed a 9-month prospective observational multicenter study comparing, for the first time, the use of two lethal agents, potassium chloride (KCl) and lidocaine. Outcomes studied were time from administration of lethal agent to fetal asystole2, 3, maternal tolerance4 and quality of the pathological data5. After epidural anesthesia, the procedure consisted of an ultrasound-guided puncture, using a 20-gauge needle, of the fetal umbilical vein or, in case of technical difficulty, of the fetal heart, followed by injection of 1.5 μg of sufentanil per kg of estimated fetal weight, and, finally, immediate injection of 100 mg (10 mL) of 1% lidocaine or 1 g (10 mL) of 10% KCl. The injection could be repeated once if fetal asystole did not occur after 1 min (maximum overall dose of 200 mg of lidocaine or 2 g of KCl). In cases in which feticide was performed for fetal anomaly, pathologists, who were blinded to the type of lethal agent used, evaluated the quality of micro- and macroscopic pathological data. Of the 37 cases of TOP included in the study, 18 were in the lidocaine group and 19 in the KCl group (Table 1). The mean time to fetal asystole did not differ significantly between the two groups: 1.66 (1–4.19) min in the lidocaine group vs 2.33 (0.61–2.83) min in the KCl group (P = 0.67). No serious side effect suggesting maternal intolerance was observed. Three cases of vasovagal reaction were observed in each group. In the KCl group, within 1 min following the injection of the lethal agent, one woman described the onset of a metallic taste in her throat, while another woman experienced a 15-s sensation of generalized paralysis, without loss of consciousness, which resolved spontaneously. Both of these women had received the minimum dose of KCl (10 mL) by the intrafunicular route. A pathological examination was conducted, with the mother's consent, in 54.1% of fetuses. The use of lidocaine or KCl was systematically associated with cell lysis. There was no significant difference between the groups in the degree of maceration, congestion, lysis or presence of crystals in the viscera (P = 1.00 for all) (Table 2 and Figure 1). In conclusion, our study showed that the use of KCl vs lidocaine for feticide in TOP does not influence the time to fetal asystole nor does it impede pathological analysis. The risk due to the possible passage of KCl to the maternal circulation indicates that lidocaine use is preferable. This work also shows the possibility of improving feticide protocols, especially regarding the management of fetal analgesia.
When an orofacial cleft lip is discovered, precise characterization of this malformation is necessary, especially the extension of this cleft to the secondary palate. We aimed to develop and evaluate the feasibility/reproducibility of a score-based quality control for the visualization of the fetal hard palate during the second-trimester scan. All ultrasound images of fetal hard palate assessed routinely during second-trimester scan were retrospectively retrieved for a 6-month period. One hundred of these images were randomly selected and analyzed by two blinded reviewers, according to a scoring system (0-6 points). Criteria retained in the score were complete palate bone horizontal plate, presence of two pterygoid processes, visible alveolar ridge, and horizontal axis of insonation. A score ≥4 defined images of good quality. Inter- and intra-reviewer reproducibility was assessed. Inter-reviewer reproducibility was excellent with significant correlation (Pearson coefficient 0.953; P < .0001), global adjusted κ coefficient (0.86, 95% CI 0.79-0.94) and individual criteria adjusted κ coefficient always > 0.8. Rates of images of good quality (score ≥ 4) were 75%-77%, also with excellent agreement (κ coefficient 0.89, 95% CI 0.79-0.99). Intra-reviewer reproducibility retrieved the same results (excellent agreement) except for the axis of insonation (satisfactory agreement). This simple image scoring system for the fetal palate is easy, has excellent inter- and intra-reviewer reproducibility and could also help sonographers to correctly identify the palate structure.
Introduction: When an orofacial cleft lip is discovered, precise characterization of this malformation is necessary, especially the extension of this cleft to the secondary palate. We aimed to develop and evaluate the feasibility/reproducibility of a score based quality control for the visualization of the fetal hard palate during the second trimester scan. Material and methods: All ultrasound images of fetal hard palate assessed routinely during second-trimester scan were retrospectively retrieved for a 6-month period. One hundred of these images were randomly selected and analyzed by two blinded reviewers, according to a scoring system (0-6 points). Criteria retained in the score were complete palate bone horizontal plate, presence of two pterygoid processes, visible alveolar ridge, and horizontal axis of insonation. A score >= 4 defined images of good quality. Inter- and intra-reviewer reproducibility was assessed. Results: Inter-reviewer reproducibility was excellent with significant correlation (Pearson coefficient 0.953; P < .0001), global adjusted kappa coefficient (0.86, 95% CI 0.79-0.94) and individual criteria adjusted kappa coefficient always > 0.8. Rates of images of good quality (score >= 4) were 75%-77%, also with excellent agreement (kappa coefficient 0.89, 95% CI 0.79-0.99). Intra-reviewer reproducibility retrieved the same results (excellent agreement) except for the axis of insonation (satisfactory agreement). Conclusions: This simple image scoring system for the fetal palate is easy, has excellent inter- and intra-reviewer reproducibility and could also help sonographers to correctly identify the palate structure.
ObjectivesThe objective of this article is to describe and assess prenatal imaging findings, fetal and postnatal outcomes of thrombosis of torcular herophili, and to determine diagnostic features, pathophysiology, prognosis, and optimal management.MethodsOver a decade, we compiled the largest single-center retrospective study of outcomes. Fetal magnetic resonance imaging (MRI) was used to confirm the sonographic suspicion and monitor thrombosis of torcular herophili. We noted prenatal and postnatal imaging specifications, pregnancy outcomes, and clinical and radiological pediatric monitoring. Analysis of findings and review of the literature allowed us to define prognostic factors.ResultsIn eight cases of prenatal diagnosis of thrombosis of torcular herophili, MRI outcomes were specific. There were five deliveries at full term, two terminations of pregnancy, and one fetal demise in utero. Neonates had a good clinical and radiological outcome. Factors of poor prognosis were deep venous sinus thrombosis, enduring mass effect, brain parenchymal injury, and heart failure related to dural arteriovenous shunt.ConclusionAmong dural sinus malformations, thrombosis of torcular herophili with or without extension at the posterior segment of the longitudinal sinus frequently has a good prognosis. It is urgent to wait because the prognosis can only be ascertained over time by means of ultrasound scan and MRI monitoring. (c) 2014 John Wiley & Sons, Ltd.