Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length: the Quadruple P randomised controlled trial.

BACKGROUND: Preterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments. METHODS/DESIGN: The Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label multicentre randomized clinical trial (RCT) with a superiority design and will be accompanied by an economic analysis. Pregnant women undergoing the routine anomaly scan will be offered cervical length measurement between 18 and 22 weeks in a singleton and at 16-22 weeks in a multiple pregnancy. Women with a short cervix, defined as less than, or equal to 35 mm in a singleton and less than 38 mm in a multiple pregnancy, will be invited to participate in the study. Eligible women will be randomly allocated to receive either progesterone or a cervical pessary. Following randomization, the silicone cervical pessary will be placed during vaginal examination or 200 mg progesterone capsules will be daily self-administered vaginally. Both interventions will be continued until 36 weeks gestation or until delivery, whichever comes first. Primary outcome will be composite adverse perinatal outcome of perinatal mortality and perinatal morbidity including bronchopulmonary dysplasia, intraventricular haemorrhage grade III and IV, periventricular leukomalacia higher than grade I, necrotizing enterocolitis higher than stage I, Retinopathy of prematurity (ROP) or culture proven sepsis. These outcomes will be measured up until 10 weeks after the expected due date. Secondary outcomes will be, among others, time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, admission to neonatal intensive care unit, maternal morbidity, maternal admission days for threatened preterm labour and costs. DISCUSSION: This trial will provide evidence on whether vaginal progesterone or a cervical pessary is more effective in decreasing adverse perinatal outcome in both singletons and multiples. TRIAL REGISTRATION: Trial registration number: NTR 4414 . Date of registration January 29th 2014.

Outcomes of pregnancies in women with pre-existing type 1 or type 2 diabetes, in an ethnically mixed population.

OBJECTIVE: To compare the outcomes of pregnancies in women with pre-existing, type 1 and type 2, diabetes and to examine the influence of ethnicity on these outcomes. DESIGN: Prospective cohort study. SETTING: Large district hospital in Yorkshire with an ethnically mixed population. SAMPLE: Case series of all 202 pregnancies in women with pre-existing diabetes, ending in miscarriage, termination of pregnancy or delivery between January 1994 and December 2002. METHODS: Univariate and multivariate logistic regression analysis comparing outcomes in type of diabetes and in ethnic group. MAIN OUTCOME MEASURES: Fetal loss, perinatal and infant mortality and congenital anomaly. RESULTS: All 14 stillbirths and infant deaths and 13 of the 15 congenital malformations were to Asian women. Analysis within this ethnic group showed a very high rate of adverse birth outcome for type 1 diabetic women and for type 2 diabetic women on insulin before the pregnancy. Total pregnancy loss among type 1 diabetic women was 156 per 1000 and among type 2 diabetic women on insulin was 167 per 1000. Congenital abnormality rates were 156 per 1000 for type 1 diabetic women and 261 per 1000 for type 2 diabetic women on insulin. Asian type 2 diabetic women not on insulin prior to pregnancy had significantly better outcomes: Total pregnancy loss was 123 per 1000 and congenital abnormality rate was 32 per 1000. After adjustment for confounders, including type of diabetes, Asian women had significantly worse outcomes (combined perinatal loss and malformation) than Caucasian women [odds ratio (OR) 4.96, 95% confidence interval (CI) 1.16-21.1]. CONCLUSION: Ethnicity has a significant impact on the outcome of diabetic pregnancies, with worse outcomes for babies born to Asian mothers compared with Caucasian mothers. The use of insulin pre-pregnancy rather than type of diabetes appears to predict adverse outcome.