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1.
Ultrasound Obstet Gynecol ; 51(5): 621-628, 2018 May.
Article in English | MEDLINE | ID: mdl-29468770

ABSTRACT

OBJECTIVE: A recent randomized clinical trial (ProTWIN) showed that a cervical pessary prevented preterm birth and improved neonatal outcome in women with multiple pregnancy and cervical length (CL) < 38 mm. In this follow-up study, the long-term developmental outcome of these children was evaluated at 3 years' corrected age. METHODS: This was a follow-up study of ProTWIN, a multicenter trial conducted between 2009 and 2012 in which asymptomatic women with a multiple pregnancy were randomized to placement of a cervical pessary or no intervention. Current follow-up and analysis were limited to mothers with a mid-trimester CL < 38 mm (78 women (157 children) in the pessary group and 55 women (111 children) in the control group). At 3 years of corrected age, surviving children were invited for a Bayley Scales of Infant and Toddler Development-third edition (Bayley-III) assessment. Death after randomization or neurodevelopmental disability (Bayley-III score of ≤ 85, 1 SD below mean) rates were compared between the pessary and control groups, according to the intention-to-treat principle and using multiple imputation for missing data. Mean Bayley-III scores in surviving children were also assessed. A linear mixed-effects model was used to adjust for correlation between children of one mother. RESULTS: From the time of entry in the ProTWIN trial until follow-up at 3 years of age, a total of 27 children had died (six (5%) in the pessary vs 21 (26%) in the control group; odds ratio (OR), 0.13; 95% CI, 0.04-0.48). Bayley-III outcomes were collected for 173/241 (72%) surviving children (114 (75%) in the pessary vs 59 (66%) in the control group). The cumulative incidence of death or survival with a neurodevelopmental disability was 12 (10%) in the pessary vs 23 (29%) in the control group (OR, 0.26; 95% CI, 0.09-0.73). No statistical or clinically relevant differences were found with respect to cognitive, language and motor development among surviving children between the groups. Comparable results were found after multiple imputation. CONCLUSION: In women with twin pregnancy and a CL < 38 mm, the use of a cervical pessary strongly improved survival of the children without affecting neurodevelopment at 3 years' corrected age. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.


Subject(s)
Neurodevelopmental Disorders/epidemiology , Pessaries , Pregnancy, Twin , Premature Birth/prevention & control , Adult , Cervical Length Measurement/statistics & numerical data , Cervix Uteri/diagnostic imaging , Child, Preschool , Female , Follow-Up Studies , Gestational Age , Humans , Infant, Newborn , Male , Neurodevelopmental Disorders/diagnosis , Neurodevelopmental Disorders/etiology , Pregnancy , Pregnancy Outcome/epidemiology , Premature Birth/epidemiology , Statistics, Nonparametric
2.
Ultrasound Obstet Gynecol ; 48(1): 48-55, 2016 Jul.
Article in English | MEDLINE | ID: mdl-26748537

ABSTRACT

OBJECTIVE: The ProTWIN Trial (NTR1858) showed that, in women with a multiple pregnancy and a cervical length < 25(th) percentile (38 mm), prophylactic use of a cervical pessary reduced the risk of adverse perinatal outcome. We investigated whether other maternal or pregnancy characteristics collected at baseline can improve identification of women most likely to benefit from pessary placement. METHODS: ProTWIN is a multicenter randomized trial in which 808 women with a multiple pregnancy were assigned to pessary or control. Using these data we developed a multivariable logistic model comprising treatment, cervical length, chorionicity, pregnancy history and number of fetuses, and the interaction of these variables with treatment as predictors of adverse perinatal outcome. RESULTS: Short cervix, monochorionicity and nulliparity were predictive factors for a benefit from pessary insertion. History of previous preterm birth and triplet pregnancy were predictive factors of possible harm from pessary. The model identified 35% of women as benefiting (95% CI, 32-39%), which is 10% more than using cervical length only (25%) for pessary decisions. The model had acceptable calibration. We estimated that using the model to guide the choice of pessary placement would reduce the risk of adverse perinatal outcome significantly from 13.5% when no pessary is inserted to 8.1% (absolute risk reduction, 5.4% (95% CI, 2.1-8.6%)). CONCLUSIONS: We developed and internally validated a multivariable treatment selection model, with cervical length, chorionicity, pregnancy history and number of fetuses. If externally validated, it could be used to identify women with a twin pregnancy who would benefit from a pessary, and lead to a reduction in adverse perinatal outcomes in these women. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.


Subject(s)
Cervical Length Measurement , Decision Making , Pessaries , Premature Birth/prevention & control , Adult , Cervix Uteri , Female , Humans , Multivariate Analysis , Netherlands , Pregnancy , Pregnancy, Multiple , Premature Birth/diagnostic imaging , Prenatal Care , Reproducibility of Results
3.
Ultrasound Obstet Gynecol ; 46(5): 579-84, 2015 Nov.
Article in English | MEDLINE | ID: mdl-25402630

ABSTRACT

OBJECTIVE: To determine whether second-trimester cervical length (CL) in women with a twin pregnancy is associated with the risk of emergency Cesarean section. METHODS: This was a secondary analysis of two randomized trials conducted in 57 hospitals in The Netherlands. We assessed the univariable association between risk indicators, including second-trimester CL in quartiles, and emergency Cesarean delivery using a logistic regression model. For multivariable analysis, we assessed whether adjustment for other risk indicators altered the associations found in univariable (unadjusted) analysis. Separate analyses were performed for suspected fetal distress and failure to progress in labor as indications for Cesarean section. RESULTS: In total, 311 women with a twin pregnancy attempted vaginal delivery after 34 weeks' gestation. Emergency Cesarean delivery was performed in 111 (36%) women, of which 67 (60%) were performed owing to arrest of labor. There was no relationship between second-trimester CL and Cesarean delivery (adjusted odds ratio (aOR): 0.97 for CL 26(th) -50(th) percentiles; 0.71 for CL 51(st) - 75(th) percentiles; and 0.92 for CL > 75(th) percentile, using CL ≤ 25(th) percentile as reference). In multivariable analysis, the only variables associated with emergency Cesarean delivery were maternal age (aOR, 1.07 (95% CI, 1.00-1.13)), body mass index (BMI) (aOR, 3.99 (95% CI, 1.07-14.9) for BMI 20-23 kg/m(2) ; 5.04 (95% CI, 1.34-19.03) for BMI 24-28 kg/m(2) ; and 3.1 (95% CI, 0.65-14.78) for BMI > 28 kg/m(2) ) and induction of labor (aOR, 1.92 (95% CI, 1.05-3.5)). CONCLUSION: In nulliparous women with a twin pregnancy, second-trimester CL is not associated with risk of emergency Cesarean delivery.


Subject(s)
Cervical Length Measurement/methods , Cervical Length Measurement/statistics & numerical data , Cervix Uteri/diagnostic imaging , Cesarean Section/statistics & numerical data , Pregnancy Complications/diagnostic imaging , Pregnancy, Twin , Adult , Female , Humans , Infant, Newborn , Labor, Obstetric , Netherlands/epidemiology , Predictive Value of Tests , Pregnancy , Pregnancy Trimester, Second , Randomized Controlled Trials as Topic , Reference Values , Risk Factors
4.
Facts Views Vis Obgyn ; 6(1): 7-12, 2014.
Article in English | MEDLINE | ID: mdl-25009720

ABSTRACT

As the classical first trimester Down syndrome screening (FTS, combination test) has a false-negative rate of 20-25% and > 95% of the abnormal FTS results are false-positive, we evaluated the new Non-Invasive Prenatal Test (NIPT) in Belgium and the Netherlands. The study population consisted of 3000 consecutive pregnancies in Belgium and the Netherlands in which NIPT was performed using the Harmony test. In 57 (1.9%) of the 3000 pregnancies an abnormal NIPT result was found. This included 51 fetuses with trisomy 21, 4 fetuses with trisomy 18 and 2 fetuses with trisomy 13. In 47 of the 57 the NIPT result was confirmed by genetic testing of material obtained by amniocentesis or chorionic biopsy, and no false-positive results were recorded. The false-negative rate as determined on more than 2000 women that had delivered at the time of reporting was low, and so far only 2 false-negative results were reported (one trisomy 18 and one trisomy 21). The failure rate where no NIPT result could be obtained after repeated sampling was 0.90%. In this large clinical series, NIPT using the Harmony test proves to be a very reliable prenatal test to detect fetal trisomies 21, 18 and 13 in maternal blood in Belgium and the Netherlands.

5.
Ultrasound Obstet Gynecol ; 44(3): 338-45, 2014 Sep.
Article in English | MEDLINE | ID: mdl-24898103

ABSTRACT

OBJECTIVE: To assess the cost-effectiveness of a cervical pessary to prevent preterm delivery in women with a multiple pregnancy. METHODS: The study design comprised an economic analysis of data from a randomized clinical trial evaluating cervical pessaries (ProTWIN). Women with a multiple pregnancy were included and an economic evaluation was performed from a societal perspective. Costs were estimated between the time of randomization and 6 weeks postpartum. The prespecified subgroup of women with a cervical length (CL) < 25(th) centile (< 38 mm) was analyzed separately. The primary endpoint was poor perinatal outcome occurring up to 6 weeks postpartum. Direct medical costs and health outcomes were estimated and incremental cost-effectiveness ratios for costs to prevent one poor outcome were calculated. RESULTS: Mean costs in the pessary group (n = 401) were € 21,783 vs € 21,877 in the group in which no pessary was used (n = 407) (difference, -€ 94; 95% CI, -€ 5975 to € 5609). In the prespecified subgroup of women with a CL < 38 mm we demonstrated a significant reduction in poor perinatal outcome (12% vs 29%; RR, 0.40; 95% CI, 0.19-0.83). Mean costs in the pessary group (n = 78) were € 25,141 vs € 30,577 in the no-pessary group (n = 55) (difference, -€ 5436 (95% CI, -€ 11,001 to € 1456). In women with a CL < 38 mm, pessary treatment was the dominant strategy (more effective and less costly) with a probability of 94%. CONCLUSION: Cervical pessaries in women with a multiple pregnancy involve costs comparable to those in women without pessary treatment. However, in women with a CL < 38 mm, treatment with a cervical pessary appears to be highly cost-effective.


Subject(s)
Cervix Uteri/drug effects , Pessaries , Premature Birth/prevention & control , Prenatal Care/economics , Adult , Cervical Length Measurement/drug effects , Cost-Benefit Analysis , Female , Humans , Models, Economic , Pessaries/economics , Pregnancy , Pregnancy Outcome , Pregnancy, Multiple , Premature Birth/economics , Prenatal Care/methods , Randomized Controlled Trials as Topic
6.
Obstet Gynecol Int ; 2013: 125897, 2013.
Article in English | MEDLINE | ID: mdl-23766761

ABSTRACT

Objective. The aim of this study was to assess whether cervical length measurement (CL) could predict preterm birth (PTB) in symptomatic women with a twin pregnancy. Methods. We searched MEDLINE and EMBASE to identify studies investigating the accuracy of CL measurement in predicting PTB in symptomatic women with a twin pregnancy. We extracted data to construct two-by-two tables and used bivariate meta-analysis to generate point estimates of sensitivity and specificity. Results. Five studies (N = 226) were included. Variation in definition of PTB and cut-off points for CL was strong. One study investigated delivery within seven days, demonstrating a sensitivity of 1.0 (95% CI: 0.83-1.0) and a specificity of 0.31 (95% CI 0.2-0.43) for a CL cutoff at 25 mm. Three studies reported on predicting PTB < 37 weeks at a CL cutoff of 30 mm, with sROC point estimates of 0.76 (95% CI: 0.66 to 0.84) and 0.37 (95% CI: 0.21 to 0.56) for sensitivity and specificity, respectively. For preterm birth <34 weeks, no pooled estimates could be estimated since only 2 studies with large heterogeneity were identified. Conclusions. There is limited evidence on the accuracy of cervical length measurement testing the prediction of preterm birth in symptomatic women with a twin pregnancy, especially on the most important outcome, that is, delivery within 7 days.

7.
Ultrasound Obstet Gynecol ; 42(3): 329-34, 2013 Sep.
Article in English | MEDLINE | ID: mdl-23592400

ABSTRACT

OBJECTIVE: Increasingly, maternal administration of 17-α-hydroxyprogesterone caproate (17-OHPC) is utilized to prevent preterm birth, but the fetal safety of 17-OHPC is still a matter of concern. This study aimed to assess whether exposure to 17-OHPC during the second and third trimesters of pregnancy affects fetal biometry in twin gestations. METHODS: This study included a subset of women with a twin pregnancy who had been previously included in a randomized clinical trial comparing the effectiveness of 17-OHPC and placebo on neonatal outcomes and preterm birth rates in multiple pregnancy. In the present study, the individual growth patterns of femur length, head circumference and abdominal circumference were compared between fetuses of women who had been randomized to receive weekly injections of either 17-OHPC (n = 52) or placebo (n = 58) at between 16-20 and 36 weeks' gestation. RESULTS: The three biometric variables assessed developed similarly in fetuses in both the group exposed to 17-OHPC and the placebo group during the second half of pregnancy. Birth weight adjusted for parity and fetal sex was also comparable between groups. CONCLUSION: The use of 17-OHPC has no adverse effects on fetal biometry and birth weight in twins.


Subject(s)
Birth Weight/drug effects , Body Size/drug effects , Hydroxyprogesterones/pharmacology , Obstetric Labor, Premature/drug therapy , Progestins/pharmacology , 17 alpha-Hydroxyprogesterone Caproate , Adult , Biometry , Female , Gestational Age , Humans , Infant, Newborn , Male , Obstetric Labor, Premature/prevention & control , Pregnancy , Pregnancy Trimester, Second , Pregnancy Trimester, Third , Pregnancy, Twin , Risk Factors , Sex Factors , Treatment Outcome , Twins
8.
BJOG ; 119(9): 1098-107, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22616913

ABSTRACT

OBJECTIVE: To evaluate the effectiveness of an exercise programme for pregnant women who were overweight or obese and at risk for gestational diabetes mellitus (GDM). DESIGN: Randomised controlled trial. SETTING: Hospitals and midwifery practices in the Netherlands. POPULATION: Pregnant women who were overweight or obese and at risk for GDM between 2007 and 2011. METHODS: Normal care was compared with an exercise training programme during pregnancy. The training consisted of aerobic and strength exercises, and was aimed at improving maternal fasting blood glucose, insulin sensitivity, and birthweight. Linear regression analyses were performed to determine the effects. MAIN OUTCOME MEASURES: Maternal outcome measures were fasting blood glucose (mmol/l), fasting insulin (pmol/l) and HbA1c (%), body weight (kg), body mass index (kg/m(2) ), and daily physical activity (minute/week). Offspring outcome measures were birthweight and fetal growth. RESULTS: A total of 121 women were randomly allocated to either a control (n = 59) or an intervention (n = 62) group. Intention-to-treat analysis showed that the exercise programme did not reduce maternal fasting blood glucose levels nor insulin sensitivity. Also, no effect was found on birthweight. CONCLUSIONS: The exercise intervention performed over the second and third trimester of pregnancy had no effects on fasting blood glucose, insulin sensitivity, and birthweight, most probably because of low compliance. The high prevalence of women at risk for GDM calls for further research on possible interventions that can prevent GDM, and other types of interventions to engage this target group in physical activity and exercise.


Subject(s)
Birth Weight/physiology , Blood Glucose/metabolism , Diabetes, Gestational/prevention & control , Exercise Therapy/methods , Insulin Resistance/physiology , Overweight/therapy , Adult , Diabetes Mellitus, Type 2/genetics , Diabetes, Gestational/blood , Diabetes, Gestational/physiopathology , Fasting/blood , Female , Gestational Age , Glycated Hemoglobin/metabolism , Humans , Overweight/blood , Overweight/physiopathology , Patient Compliance , Pedigree , Pregnancy , Pregnancy Outcome , Pregnancy Trimester, Second , Pregnancy Trimester, Third
9.
BMJ ; 341: c7087, 2010 Dec 21.
Article in English | MEDLINE | ID: mdl-21177352

ABSTRACT

OBJECTIVE: To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term. DESIGN: Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)). SETTING: Eight academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008. PARTICIPANTS: Pregnant women who had a singleton pregnancy beyond 36+0 weeks' gestation with suspected intrauterine growth restriction. INTERVENTIONS: Induction of labour or expectant monitoring. MAIN OUTCOME MEASURES: The primary outcome was a composite measure of adverse neonatal outcome, defined as death before hospital discharge, five minute Apgar score of less than 7, umbilical artery pH of less than 7.05, or admission to the intensive care unit. Operative delivery (vaginal instrumental delivery or caesarean section) was a secondary outcome. Analysis was by intention to treat, with confidence intervals calculated for the differences in percentages or means. RESULTS: 321 pregnant women were randomly allocated to induction and 329 to expectant monitoring. Induction group infants were delivered 10 days earlier (mean difference -9.9 days, 95% CI -11.3 to -8.6) and weighed 130 g less (mean difference -130 g, 95% CI -188 g to -71 g) than babies in the expectant monitoring group. A total of 17 (5.3%) infants in the induction group experienced the composite adverse neonatal outcome, compared with 20 (6.1%) in the expectant monitoring group (difference -0.8%, 95% CI -4.3% to 3.2%). Caesarean sections were performed on 45 (14.0%) mothers in the induction group and 45 (13.7%) in the expectant monitoring group (difference 0.3%, 95% CI -5.0% to 5.6%). CONCLUSIONS: In women with suspected intrauterine growth restriction at term, we found no important differences in adverse outcomes between induction of labour and expectant monitoring. Patients who are keen on non-intervention can safely choose expectant management with intensive maternal and fetal monitoring; however, it is rational to choose induction to prevent possible neonatal morbidity and stillbirth. TRIAL REGISTRATION: International Standard Randomised Controlled Trial number ISRCTN10363217.


Subject(s)
Fetal Growth Retardation/therapy , Labor, Induced , Watchful Waiting , Adult , Female , Gestational Age , Humans , Labor Onset , Length of Stay , Pregnancy , Pregnancy Outcome , Young Adult
10.
BJOG ; 117(13): 1577-85, 2010 Dec.
Article in English | MEDLINE | ID: mdl-20840526

ABSTRACT

OBJECTIVE: To assess the economic consequences of labour induction compared with expectant monitoring in women with gestational hypertension or pre-eclampsia at term. DESIGN: An economic analysis alongside the Hypertension and Pre-eclampsia Intervention Trial At Term (HYPITAT). SETTING: Obstetric departments of six university and 32 teaching and district hospitals in the Netherlands. POPULATION: Women diagnosed with gestational hypertension or pre-eclampsia between 36(+0) and 41(+0) weeks of gestation, randomly allocated to either induction of labour or expectant monitoring. METHODS: A trial-based cost-effectiveness analysis was performed from a societal perspective during a 1-year time horizon. MAIN OUTCOME MEASURES: One-year costs were estimated and health outcomes were expressed as the prevalence of poor maternal outcome defined as either maternal complications or progression to severe disease. RESULTS: The average costs of induction of labour (n = 377) were €7077 versus €7908 for expectant monitoring (n = 379), with an average difference of -€831 (95% CI -€1561 to -€144). This 11% difference predominantly originated from the antepartum period: per woman costs were €1259 for induction versus €2700 for expectant monitoring. During delivery, more costs were generated following induction (€2190) compared with expectant monitoring (€1210). No substantial differences were found in the postpartum, follow-up and for non-medical costs. CONCLUSION: In women with gestational hypertension or mild pre-eclampsia at term, induction of labour is less costly than expectant monitoring because of differences in resource use in the antepartum period. As the trial already demonstrated that induction of labour results in less progression to severe disease without resulting in a higher caesarean section rate, both clinical and economic consequences are in favour of induction of labour in these women. TRIAL REGISTRATION: The trial has been registered in the clinical trial register as ISRCTN08132825.


Subject(s)
Hypertension, Pregnancy-Induced/economics , Labor, Induced/economics , Pre-Eclampsia/economics , Watchful Waiting/economics , Cost of Illness , Cost-Benefit Analysis , Female , Health Resources/economics , Humans , Hypertension, Pregnancy-Induced/therapy , Length of Stay , Netherlands , Pre-Eclampsia/therapy , Pregnancy
11.
BJOG ; 115(9): 1131-7, 2008 Aug.
Article in English | MEDLINE | ID: mdl-18518872

ABSTRACT

OBJECTIVE: The aim of this study was to describe the variation of normal maternal temperature during labour. Design A prospective cohort study. SETTING: Two hospitals in Amsterdam, the Netherlands. POPULATION: All women with a live singleton pregnancy and a gestational age of 36 weeks or more admitted to the delivery ward from June 2000 to January 2002. METHODS: Maternal temperature was measured rectally every 2-3 hours from admission until the beginning of second stage, and 1-hour postpartum. Normal labour (n = 843) was defined as gestational age > or =37 weeks, spontaneous onset of labour, rupture of membranes <18 hours before birth, normal progress of labour without the need for augmentation or epidural analgesia and spontaneous vaginal delivery of a healthy infant. The remaining group was classified as abnormal (n = 2209). MAIN OUTCOME MEASURES: Rectal measured temperature in degrees Celsius. RESULTS: The mean temperature during labour in the complete study population increased from 37.1 degrees C at the beginning of labour to 37.4 degrees C after 22 hours. Temperature in the abnormal labour group was equal to the normal labour group during the first 3 hours of labour (P > 0.05) but increased thereafter. CONCLUSIONS: At the beginning of labour, temperature was 37.1 degrees C. Temperature increased slowly during labour and was 37.4 degrees C (2SD 1.2) after 22 hours. The upper 2SD limit for normal temperature did not follow a circadian pattern and time of day is not relevant for the classification of normal versus elevated temperature.


Subject(s)
Body Temperature/physiology , Labor, Obstetric/physiology , Pregnancy/physiology , Adult , Analysis of Variance , Circadian Rhythm/physiology , Cohort Studies , Female , Humans
12.
Ned Tijdschr Geneeskd ; 151(21): 1157-62, 2007 May 26.
Article in Dutch | MEDLINE | ID: mdl-17557753

ABSTRACT

Three pregnant women, of whom 2 were 33 and 1 was 35 years of age, were seen; 2 of them had upper abdominal pain and 1had oedema. All had proteinuria and liver enzyme abnormalities, and pre-eclampsia or the HELLP syndrome was suspected. They were consequently admitted and at first treated with antihypertensive agents. One patient underwent a Caesarean section and the baby had a good start. Afterwards, however, the patient developed shock. A CT-scan revealed a hepatic rupture, for which repeated surgical packing of the liver was carried out. The postoperative course was complicated. A second patient developed shock and the foetus died. Here the CT-scan revealed a liver haematoma. At surgery the next day, removal of the foetus was followed by heavy uterine bleeding. The patient again developed shock and the uterus was resected. A haematoma that was seen in the liver was treated expectatively. The postoperative course was not complicated. In a third patient, abdominal echography revealed bleeding from the liver. Simultaneous Caesarean section and surgical exploration of the liver took place, with packing of the liver. The child had Apgar scores of 4, 7 and 9. After re-laparotomy because of persistent bleeding from the liver the patient recovered. Spontaneous liver haemorrhage and hepatic rupture during pregnancy is a rare condition associated with significant maternal and perinatal mortality. The majority of cases occur during pregnancies complicated by pre-eclampsia or the HELLP syndrome. The presenting symptoms are non-specific. A high index of suspicion is important and early evaluation with imaging is necessary to improve the prognosis of both mother and child.


Subject(s)
Cesarean Section , Hemorrhage/diagnosis , Liver Diseases/diagnosis , Pregnancy Complications/diagnosis , Pregnancy Outcome , Abdominal Pain/etiology , Adult , Edema/etiology , Female , HELLP Syndrome , Hematoma/complications , Hematoma/diagnostic imaging , Hematoma/surgery , Hemorrhage/complications , Hemorrhage/surgery , Humans , Infant, Newborn , Liver Diseases/complications , Liver Diseases/surgery , Pre-Eclampsia/diagnosis , Pre-Eclampsia/surgery , Pregnancy , Pregnancy Complications/surgery , Radiography , Rupture, Spontaneous/complications , Rupture, Spontaneous/diagnosis , Shock, Hemorrhagic/etiology
13.
Ultrasound Obstet Gynecol ; 20(2): 163-7, 2002 Aug.
Article in English | MEDLINE | ID: mdl-12153667

ABSTRACT

OBJECTIVE: To compare the effects of therapeutic cerclage and bed rest vs. just bed rest on cervical length and to relate these effects to the risk of preterm delivery. DESIGN: Cervical length was measured in patients at high risk of cervical incompetence. When a cervical length < 25 mm was measured before 27 weeks' gestation, randomization for therapeutic cerclage and bed rest vs. just bed rest was performed. After randomization, cervical length was measured weekly. For statistical analysis, t-test and Fisher's exact tests were used and P < 0.05 was considered statistically significant. RESULTS: Nineteen women were randomly allocated to receive a therapeutic cerclage and bed rest and 16 were allocated to receive bed rest only. Mean cervical lengths and mean gestational ages before randomization were comparable between both groups, overall 19.8 mm and 20.7 weeks. Cervical length was measured again at a mean gestation of 22.1 weeks. Mean cervical length (31 mm) was significantly (P < 0.0001) longer after cerclage than after bed rest only (19 mm). A cervical length > or = 25 mm was measured in 22 of the 35 included women, 16 in the cerclage group and six in the bed-rest group (P = 0.006). Of these 22 women, only one delivered before 34 weeks' gestation, which was significantly less frequent than six out of 13 women with a cervical length < 25 mm (P = 0.006). CONCLUSIONS: Therapeutic cerclage with bed rest increases cervical length more often than bed rest alone. A postintervention cervical length > or = 25 mm reduces the risk of preterm delivery in women at high risk of cervical incompetence and a preintervention cervical length < 25 mm.


Subject(s)
Bed Rest , Cerclage, Cervical , Cervix Uteri/pathology , Uterine Cervical Incompetence/therapy , Adult , Female , Humans , Treatment Outcome , Uterine Cervical Incompetence/pathology , Uterine Cervical Incompetence/surgery
14.
Am J Obstet Gynecol ; 185(5): 1106-12, 2001 Nov.
Article in English | MEDLINE | ID: mdl-11717642

ABSTRACT

OBJECTIVE: To compare preterm delivery rates (before 34 weeks of gestation) and neonatal morbidity and mortality in patients with risk factors or symptoms of cervical incompetence managed with therapeutic McDonald cerclage and bed rest versus bed rest alone. STUDY DESIGN: Cervical length was measured in patients with risk factors or symptoms of cervical incompetence. Risk factors for cervical incompetence included previous preterm delivery before 34 weeks of gestation that met clinical criteria for the diagnosis of cervical incompetence, previous preterm premature rupture of membranes before 32 weeks of gestation, history of cold knife conization, diethylstilbestrol exposure, and uterine anomaly. When a cervical length of <25 mm was measured before a gestational age of 27 weeks, a randomization for therapeutic cerclage and bed rest (cerclage group) or bed rest alone (bed rest group) was performed. The analysis is based on intention to treat. RESULTS: Of the 35 women who met the inclusion criteria, 19 were allocated randomly to the cerclage group and 16 to the bed rest group. Both groups were comparable for mean cervical length and mean gestational age at time of randomization, mean overall 20 mm and 21 weeks. Preterm delivery before 34 weeks was significantly more frequent in the bed rest group than in the cerclage group (7 of 16 vs none, respectively; P =.002). There was no statistically significant difference in neonatal survival between the groups (13 neonates survived in the bed rest group vs all in the cerclage group). The compound neonatal morbidity, defined as admission to the neonatal intensive care unit or neonatal death, was significantly higher in the bed rest group than in the cerclage group (8 of 16 vs 1 of 19, respectively; P =.005; RR = 9.5, 95% CI, 1.3-68.1). CONCLUSIONS: Therapeutic cerclage with bed rest reduces preterm delivery before 34 weeks of gestation and compound neonatal morbidity in women with risk factors and/or symptoms of cervical incompetence and a cervical length of <25 mm before 27 weeks of gestation.


Subject(s)
Bed Rest , Cerclage, Cervical , Cervix Uteri/surgery , Uterine Cervical Incompetence/prevention & control , Cervix Uteri/diagnostic imaging , Female , Humans , Incidence , Infant, Newborn , Infant, Newborn, Diseases/prevention & control , Obstetric Labor, Premature/epidemiology , Obstetric Labor, Premature/prevention & control , Pregnancy , Risk Factors , Ultrasonography , Uterine Cervical Incompetence/etiology
15.
Am J Obstet Gynecol ; 183(4): 823-9, 2000 Oct.
Article in English | MEDLINE | ID: mdl-11035320

ABSTRACT

OBJECTIVE: The objective of this study was to compare different management strategies for women at risk for cervical incompetence. STUDY DESIGN: In an ongoing randomized trial patients with a previous preterm delivery at <34 weeks' gestation who met clinical criteria for the diagnosis of cervical incompetence are allocated to receive a prophylactic cerclage (prophylactic cerclage group) or not (observational group) in a proportion of 1:2. Transvaginal ultrasonographic follow-up examination of the cervix is performed in both groups. When a patient of the latter group has a cervical length <25 mm at <27 weeks' gestation, a further random assignment of therapeutic cerclage or no cerclage is performed. The analysis is by intent to treat. RESULTS: Primary random assignment allocated 23 women to the prophylactic cerclage group and 44 to the observational group. Both groups were comparable with respect to obstetric history. No significant difference was found between the prophylactic cerclage group and the observational group in preterm delivery at <34 weeks' gestation (3/23 vs 6/44, respectively) and neonatal survival (21/23 vs 41/44, respectively). A cervical length <25 mm was found in 18 patients (41%) in the observational group at a mean gestational age of 19.1 +/- 2.9 weeks' gestation. Incidence of preterm delivery at <34 weeks' gestation was significantly higher in the group with short cervical length (6/18 vs 0/26; P =.003). Secondary random assignment of the 18 patients with short cervical length allocated 10 to undergo therapeutic cerclage. Preterm delivery at <34 weeks' gestation was significantly less frequent in the therapeutic cerclage group (1/10 vs 5/8). CONCLUSION: Transvaginal ultrasonographic serial follow-up examinations of the cervix in women at risk for cervical incompetence, with secondary intervention as indicated, appears to be a safe alternative to the traditional prophylactic cerclage. Transvaginal ultrasonographic follow-up examination of the cervix can save the majority of women from unnecessary intervention. Placement of a therapeutic cerclage may reduce the incidence of preterm delivery at <34 weeks' gestation among high-risk patients.


Subject(s)
Cervix Uteri/surgery , Obstetric Surgical Procedures , Suture Techniques , Uterine Cervical Incompetence/prevention & control , Cervix Uteri/diagnostic imaging , Female , Humans , Incidence , Obstetric Labor, Premature/epidemiology , Obstetric Labor, Premature/prevention & control , Pregnancy , Research Design , Ultrasonography
16.
Eur J Epidemiol ; 14(7): 693-9, 1998 Oct.
Article in English | MEDLINE | ID: mdl-9849831

ABSTRACT

Zeeburg', a multiethnic town borough in the Amsterdam-East region, has one of the city's highest rates of immigrants. In the total population of 19,825 Surinam (mainly Creole), Turkish, Moroccan, and Dutch adults the prevalence of known type 2 diabetes in 1994 and of gestational diabetes mellitus (GDM) between January 1992 and January 1997 was investigated. Based on World Health Organization (WHO) criteria of 1985, the age-standardized prevalence of type 2 diabetes was similar in men (6.4%; 95% confidence interval [CI]: 5.6-7.2) and women (6.4%: 95% CI: 5.8-7.0) for all ethnic groups combined. However, the age- and sex-standardized prevalence of type 2 diabetes was significantly greater in the non-Dutch inhabitants than in the Dutch inhabitants (17.3% [95% CI: 12.9-21.6] in Surinam inhabitants, 10.9% [95% CI: 9.7-12.2] in Turkish inhabitants, 12.4% [95% CI: 9.7-15.0] in Moroccan inhabitants, and 3.6% [95% CI: 3.2-3.9] in Dutch inhabitants). The odds ratios for type 2 diabetes for the separate immigrant groups relative to the Dutch group were 5.88 (95% CI: 4.54-7.69) for Surinam inhabitants, 4.00 (95% CI: 2.86-5.55) for Turkish inhabitants, and 4.17 (95% CI: 3.03-5.55) for Moroccan inhabitants. GDM was present in 2.59% of women of non-Dutch origin compared with 0.62% of women of Dutch origin. A significant positive association was found between the non-Dutch origin and the occurrence of GDM (chi2 = 6.7; p < 0.01). The study highlights a high prevalence of known type 2 diabetes and GDM in the immigrant inhabitants and emphasizes that appropriate interventions are necessarily with implications for health targets and capitation based budgets.


Subject(s)
Diabetes Mellitus, Type 2/epidemiology , Diabetes, Gestational/epidemiology , Adult , Aged , Diabetes Mellitus, Type 2/ethnology , Diabetes, Gestational/ethnology , Female , Humans , Male , Middle Aged , Netherlands/epidemiology , Population Surveillance , Pregnancy , Prevalence , Urban Population
17.
Prenat Diagn ; 15(5): 467-73, 1995 May.
Article in English | MEDLINE | ID: mdl-7644437

ABSTRACT

We report two cases of apparently balanced complex de novo chromosomal rearrangements (BCCR) detected prenatally at 17 weeks and 10 weeks of gestation, respectively. Chromosomes were studied using GTG-banding and fluorescent in situ hybridization (FISH). In one case four chromosomes and in the other case three chromosomes were involved in the rearrangements. One of the pregnancies was terminated and no external or internal showed no abnormalities. The child is now 3 years old and has neither congenital anomalies nor evidence of delayed psychomotor development.


Subject(s)
Chromosome Aberrations , Prenatal Diagnosis , Adult , Amniocentesis , Chorionic Villi Sampling , Female , Follow-Up Studies , Humans , In Situ Hybridization, Fluorescence , Karyotyping , Male , Maternal Age , Pregnancy , Pregnancy, High-Risk
18.
Early Hum Dev ; 32(1): 63-9, 1993 Feb.
Article in English | MEDLINE | ID: mdl-8462434

ABSTRACT

A case is reported in which qualitatively, grossly abnormal fetal breathing movements turned out to be indicative of complete tracheal atresia. Fetal breathing movements were vigorous and jerky and of large amplitude; similarly abnormal movements were observed after birth. At postmortem tracheal atresia was diagnosed, in combination with other congenital abnormalities, which pointed to a VATER-association. The combination of a VATER-association with tracheal atresia has only been reported once before. An absence of the normal Hering-Breuer reflex in this case of complete tracheal atresia, probably explains the abnormal fetal breathing pattern. This case is in line with a growing number of reports in literature in which qualitatively abnormal fetal movements were indicative of congenital malformations.


Subject(s)
Abnormalities, Multiple/physiopathology , Fetal Diseases/physiopathology , Respiratory Mechanics , Trachea/abnormalities , Ultrasonography, Prenatal , Adult , Anus, Imperforate , Female , Humans , Kidney/abnormalities , Pregnancy , Spine/abnormalities , Trachea/diagnostic imaging , Trachea/embryology , Trachea/physiopathology , Tracheoesophageal Fistula
19.
Early Hum Dev ; 27(3): 223-32, 1991 Dec.
Article in English | MEDLINE | ID: mdl-1802673

ABSTRACT

In hypoxemic intrauterine growth-retarded fetuses (IUGR) there is a reduction in the incidence of fetal movements and in fetal heart rate variation. A causal relationship with the impairment of fetal oxygenation has been suggested. In 16 IUGR fetuses and in 13 normally grown fetuses maternal hyperoxygenation was applied for 40 min to increase fetal PO2 levels. All IUGR fetuses had abnormal Doppler blood velocity waveforms of the umbilical artery suggesting an impaired uteroplacental exchange. The effect of hyperoxygenation on fetal breathing and body movements and on fetal heart rate was evaluated. In the IUGR fetuses there was a significant increase in fetal breathing and body movements and in heart rate variation during hyperoxygenation as compared to the preceding control period of 40 min. No significant changes in fetal breathing and body movements were found in the normally grown control fetuses. A surprising observation was the increase of the number of heart rate decelerations after discontinuation of the maternal hyperoxygenation. It is concluded that in IUGR fetuses the increase in fetal heart rate variation and the increase in the incidence of breathing and body movements during maternal hyperoxygenation substantiates the relationship between these variables and the oxygenation status of the fetus.


Subject(s)
Fetal Growth Retardation , Fetus/drug effects , Heart Rate, Fetal/drug effects , Movement/drug effects , Oxygen/pharmacology , Respiration/drug effects , Female , Humans , Maternal-Fetal Exchange , Pregnancy
20.
Early Hum Dev ; 24(1): 79-89, 1990 Oct.
Article in English | MEDLINE | ID: mdl-2124965

ABSTRACT

In 70 intrauterine growth-retarded (IUGR) fetuses with antepartum late heart rate decelerations recordings of velocity waveforms of the umbilical artery were made with Doppler ultrasound and calculated as pulsatility indexes (PI). In 29 of these fetuses longitudinal recordings were made. Abnormal PIs preceded the occurrence of late heart rate decelerations in 27 (93%) of the 29 fetuses. The median duration of the interval between the first abnormal PI and the first appearance of antenatal heart rate decelerations was 17 days (range 0-60 days). This wide range can mainly be attributed to the gestational age at which the first abnormal velocity wave-form was recorded; during early gestation the interval was much longer than later in pregnancy. Absent end-diastolic velocity (AEDV) was found in 17 of the 29 fetuses (59%) and preceded the occurrence of decelerations with a median interval of 12 days. In the total group, 4 of the 70 IUGR fetuses with antepartum decelerations had a normal velocity waveform of the umbilical artery. Fetuses with AEDV (n = 45) were more severely growth retarded and were delivered at an earlier gestational age than those with end-diastolic velocity (n = 25). Also perinatal mortality and morbidity were higher in the group with AEDV. Yet, when fetuses were matched for gestational age and birth weight no differences in perinatal outcome were found in the groups with and without end-diastolic velocity.


Subject(s)
Fetal Growth Retardation/physiopathology , Heart Rate, Fetal , Umbilical Arteries/physiology , Adult , Apgar Score , Birth Weight , Carbon Dioxide/blood , Cross-Sectional Studies , Echocardiography, Doppler , Female , Gestational Age , Humans , Hydrogen-Ion Concentration , Infant, Newborn , Longitudinal Studies , Oxygen/blood , Pregnancy , Pregnancy Outcome , Retrospective Studies
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