A Randomized Trial of a Cervical Pessary to Prevent Preterm Singleton Birth.

BACKGROUND: Preterm birth is the leading cause of neonatal and infant death and of disability among survivors. It is unclear whether a pessary inserted around the cervix reduces the risk of preterm singleton birth. METHODS: We conducted a multicenter, randomized, controlled trial comparing pessary placement with expectant management (control) in girls and women who were pregnant with singletons (singleton pregnancies) and who had a cervical length of 25 mm or less at 20 weeks 0 days to 24 weeks 6 days of gestation. Participants in either group who had a cervical length of 15 mm or less, at randomization or at subsequent visits, received treatment with vaginal progesterone. The primary outcome was spontaneous delivery before 34 weeks of gestation. RESULTS: In an intention-to-treat analysis, there was no significant difference between the pessary group (465 participants) and the control group (467 participants) in the rate of spontaneous delivery before 34 weeks (12.0% and 10.8%, respectively; odds ratio in the pessary group, 1.12; 95% confidence interval, 0.75 to 1.69; P=0.57). There were no significant differences in the rates of perinatal death (3.2% in the pessary group and 2.4% in the control group, P=0.42), adverse neonatal outcome (6.7% and 5.7%, respectively; P=0.55), or neonatal special care (11.6% and 12.9%, respectively; P=0.59). The incidence of new or increased vaginal discharge was significantly higher in the pessary group than in the control group. CONCLUSIONS: Among girls and women with singleton pregnancies who had a short cervix, a cervical pessary did not result in a lower rate of spontaneous early preterm delivery than the rate with expectant management. (Funded by the Fetal Medicine Foundation; Current Controlled Trials number, ISRCTN01096902.).

Maternal serum progesterone-induced blocking factor at 11-13 weeks' gestation in spontaneous early preterm delivery.

OBJECTIVE: Progesterone-induced blocking factor (PIBF) may be the mediator of the pregnancy maintenance effects of progesterone. The aim of this study is to investigate the potential value of measuring the maternal serum concentration of PIBF at 11-13 weeks' gestation in the prediction of spontaneous early preterm delivery. METHOD: The maternal serum concentration of PIBF at 11-13 weeks was measured by enzyme-linked immunosorbent assay in 25 singleton pregnancies which subsequently delivered spontaneously before 34 weeks, and 75 controls who delivered at or after 37 weeks. The values in the 2 groups were compared by the Mann-Whitney U test. RESULTS: The median maternal serum concentration of PIBF in women who subsequently delivered before 34 weeks (157.5, interquartile range 99.5-208.8 ng/ml) was not significantly different from the control group delivering at term (167.5, interquartile range 105.0-212.0 ng/ml; p = 0.519). CONCLUSIONS: In women who have a spontaneous early preterm delivery, the maternal serum levels of PIBF are not altered at 11-13 weeks of gestation.

Maternal serum placental protein 13 at eleven to thirteen weeks in chromosomally abnormal pregnancies.

OBJECTIVE: To investigate whether the maternal serum concentration of placental protein 13 (PP13) is altered in chromosomally abnormal pregnancies and to examine the potential value of this placental protein in screening for aneuploidies at 11-13 weeks. METHODS: The maternal serum concentration of PP13 at 11-13 weeks was compared in 536 euploid and 134 aneuploid pregnancies (trisomy 21: n = 49; trisomy 18: n = 28; trisomy 13: n = 19; Turner syndrome: n = 28; triploidy: n = 10). RESULTS: Serum PP13, expressed as multiples of the median (MoM) of the euploid group, was not significantly different in trisomy 21 (1.12 MoM) pregnancies, but the levels were decreased in trisomy 18 (0.75 MoM), trisomy 13 (0.65 MoM), Turner syndrome (0.61 MoM) and triploidy (0.19 MoM). In both euploid and aneuploid pregnancies there was a significant association of serum PP13 with both serum pregnancy-associated plasma protein A (PAPP-A) and free beta-human chorionic gonadotropin (beta-hCG; p < 0.0001 for both). Logistic regression analysis demonstrated that the addition of serum PP13 did not improve the prediction of trisomy 13 and 18 provided by a combination of maternal age, nuchal translucency, and serum free beta-hCG and PAPP-A. CONCLUSION: The measurement of maternal serum PP13 at 11-13 weeks does not improve the performance of screening for aneuploidies achieved by current algorithms.

Maternal serum angiopoietin-2 at 11 to 13 weeks of gestation in hypertensive disorders of pregnancy.

OBJECTIVE: In women with preeclampsia (PE), the serum concentration of the growth factor angiopoietin-2 (Ang-2) is significantly lower than in unaffected controls. The objective of this study is to determine if the decrease in serum Ang-2 is evident from the first trimester of pregnancy before the clinical onset of PE. METHODS: Serum Ang-2 and uterine artery pulsatility index (PI) were measured at 11 to 13 weeks in 126 pregnancies that subsequently developed PE, 88 cases that developed gestational hypertension (GH) and 214 unaffected controls. RESULTS: Maternal serum Ang-2 in the PE group [0.96 multiple of the median (MoM)] and in GH (1.12 MoM) was not significantly different from the unaffected group (1.07 MoM). Uterine artery PI was significantly higher in the PE group (1.32 MoM) but not in GH (1.11 MoM) compared to the unaffected group (1.05 MoM). CONCLUSION: In pregnancies that develop PE there is Doppler evidence of impaired placentation from the first trimester of pregnancy. However, the impaired placentation is not reflected in altered maternal serum levels of Ang-2.