The likelihood of rupture of unruptured intracranial aneurysms that were less than 10 mm in diameter was exceedingly low among patients in group 1 and was substantially higher among those in group 2. The risk of morbidity and mortality related to surgery greatly exceeded the 7.5-year risk of rupture among patients in group 1 with unruptured intracranial aneurysms smaller than 10 mm in diameter.
Follow-up by a gynecologist is advised to check for intra-abdominal disease and inform patients on fertility perspective. Surgeons should be aware of the possibility of inguinal endometriosis in fertile women with a lump in the groin.
Objective To evaluate the long‐term outcomes of children born to women with a short cervix and otherwise low risk for preterm birth, after antenatal exposure to vaginal progesterone vs placebo. Methods This was a follow‐up study of the Triple P trial, which randomized 80 low‐risk women with a short cervix (≤ 30 mm) at 18–22 weeks' gestation to progesterone (n = 41) or placebo (n = 39). At 2 years of corrected age, children were invited for a neurodevelopmental assessment, using the Bayley Scales of Infant and Toddler Development, third edition (BSID‐III), and a neurological and physical examination by an assessor blinded to the allocated treatment. Parents filled out the Ages and Stages Questionnaire, the Child Behavior Checklist (CBCL) and a general‐health questionnaire. The main outcome of interest was mean BSID‐III cognitive and motor scores. Additionally, a composite score of mortality and abnormal developmental outcome, including BSID‐III ≤–1 SD, CBCL score in the clinical range and/or parental reported physical problems (at least two operations or at least two hospital admissions in the previous 2 years), was evaluated. Our sample size, dictated by the original sample of the Triple P trial, provided 80% power to detect a mean difference (MD) of 15 points (1 SD) between groups for the BSID‐III tests. Results Of the 80 children born to the randomized women, one in the progesterone group and two in the placebo group died in the neonatal period. Follow‐up data were obtained for 59/77 (77%) children and BSID‐III outcomes in 57 children (n = 28 in the progesterone group and n = 29 in the placebo group) born at a median gestational age of 38 + 6 weeks (interquartile range (IQR), 37 + 3 to 40 + 1 weeks) with a median birth weight of 3240 g (IQR, 2785–3620 g). In the progesterone vs placebo groups, mean BSID‐III cognitive development scores were 101.6 vs 105.0 (MD, –3.4 (95% CI, –9.3 to 2.6); P = 0.29) while mean motor scores were 102.4 vs 107.3 (MD, –4.9 (95% CI, –11.2 to 1.4); P = 0.13). No differences were seen between the two groups in physical (including genital and neurological examination), behavioral and health‐related outcomes. Conclusion In this sample of children born to low‐risk women with a short cervix at screening, no relevant differences in neurodevelopmental, behavioral, health‐related and physical outcomes were found between offspring exposed to vaginal progesterone and those exposed to placebo. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
IntroductionThe ProTWIN trial previously showed no beneficial effect of treatment with a cervical pessary vs usual care to prevent preterm birth in women with a multiple pregnancy. However, in women with a midtrimester short cervix (<38 mm), pessary did reduce the composite outcome of neonatal morbidity and mortality. This follow‐up study evaluates the long‐term outcomes of all children born to mothers who participated in the ProTWIN trial at 4 years of age.Material and methodsParents received the Ages and Stages Questionnaire, Strength and Difficulties Questionnaire and a health questionnaire. All questionnaires were reported separately and as a combined outcome (abnormal child outcome). A linear mixed effects model was used to adjust for correlated data in twins and correction for confounders was performed. In exploratory analysis, a composite outcome of death or survival with abnormal child outcome was used by combining extrapolated data on child outcome with survival data. All data were analyzed for the total group and the subgroup of women with midtrimester short cervix.ResultsOf the original 813 women of the ProTWIN trial, we approached 579, of whom 258 participated (45%) in follow‐up. We received questionnaires of 514 children (281 pessary vs 233 control), with 119 children in the subgroup of women with midtrimester short cervix. An abnormal child outcome was found in 23% in the pessary group vs 16% in the control group (odds ratio 1.58; 95% confidence interval 0.94‐2.65). In exploratory analysis with extrapolated data on child outcome (n = 815), no difference in abnormal child outcome was seen between the pessary and control group. In the subgroup of women with a short cervix (n = 268), this composite outcome indicated a favorable outcome for children born to mothers with pessary.ConclusionsIn women with a multiple pregnancy, the use of a cervical pessary did not improve development, behavior or physical outcomes of the surviving children at age 4.
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