Vaginal micronized progesterone and risk of preterm delivery in high-risk twin pregnancies: secondary analysis of a placebo-controlled randomized trial and meta-analysis

TY - JOUR

T1 - Vaginal micronized progesterone and risk of preterm delivery in high-risk twin pregnancies: secondary analysis of a placebo-controlled randomized trial and meta-analysis

AU - Klein, K

AU - Rode, L

AU - Nicolaides, K H

AU - Krampl-Bettelheim, E

AU - Tabor, A

AU - PREDICT Group

AU - Hansen, Bo Mølholm

AU - Lando, Ane

AU - Zingenberg, Helle Jeanette

N1 - Copyright © 2011 ISUOG. Published by John Wiley & Sons, Ltd.

PY - 2011/9

Y1 - 2011/9

N2 - Objectives Progesterone treatment reduces the risk of preterm delivery in high-risk singleton pregnancies. Our aim was to evaluate the preventive effect of vaginal progesterone in high-risk twins. Methods This was a subanalysis of a Danish-Austrian, double-blind, placebo-controlled, randomized trial (PREDICT study), in which women with twin pregnancies were randomized to daily treatment with progesterone or placebo pessaries from 20-24 weeks until 34 weeks' gestation. This subpopulation consisted of high-risk pregnancies, defined by the finding of cervical length ≤ 10;bsupesup centile at 20-24 weeks' gestation or history of either spontaneous delivery before 34 weeks or miscarriage after 12 weeks. Primary outcome was delivery before 34 weeks. Secondary outcomes were complications for infants including long-term follow-up by Ages and Stages Questionnaire (ASQ) at 6 and 18 months of age. Results In 72 (10.6%) of the 677 women participating in the PREDICT study, the pregnancy was considered to be high-risk, including 47 with cervical length a;circ 10th centile, 28 with a history of preterm delivery or late miscarriage and three fulfilling both criteria. Baseline characteristics for progesterone and placebo groups were similar. Mean gestational age at delivery did not differ significantly between the two groups either in patients with a short cervix (34.3 ± 4.1 vs 34.5 ± 3.0 weeks, P = 0.87) or in those with a history of preterm delivery or late miscarriage (34.6 ± 4.2 vs 35.2 ± 2.7 weeks, P = 0.62). Similarly, there were no significant differences between the treatment groups in maternal or neonatal complications and mean ASQ score at 6 and 18 months of age. Conclusion In high-risk twin pregnancies, progesterone treatment does not significantly improve outcome.

AB - Objectives Progesterone treatment reduces the risk of preterm delivery in high-risk singleton pregnancies. Our aim was to evaluate the preventive effect of vaginal progesterone in high-risk twins. Methods This was a subanalysis of a Danish-Austrian, double-blind, placebo-controlled, randomized trial (PREDICT study), in which women with twin pregnancies were randomized to daily treatment with progesterone or placebo pessaries from 20-24 weeks until 34 weeks' gestation. This subpopulation consisted of high-risk pregnancies, defined by the finding of cervical length ≤ 10;bsupesup centile at 20-24 weeks' gestation or history of either spontaneous delivery before 34 weeks or miscarriage after 12 weeks. Primary outcome was delivery before 34 weeks. Secondary outcomes were complications for infants including long-term follow-up by Ages and Stages Questionnaire (ASQ) at 6 and 18 months of age. Results In 72 (10.6%) of the 677 women participating in the PREDICT study, the pregnancy was considered to be high-risk, including 47 with cervical length a;circ 10th centile, 28 with a history of preterm delivery or late miscarriage and three fulfilling both criteria. Baseline characteristics for progesterone and placebo groups were similar. Mean gestational age at delivery did not differ significantly between the two groups either in patients with a short cervix (34.3 ± 4.1 vs 34.5 ± 3.0 weeks, P = 0.87) or in those with a history of preterm delivery or late miscarriage (34.6 ± 4.2 vs 35.2 ± 2.7 weeks, P = 0.62). Similarly, there were no significant differences between the treatment groups in maternal or neonatal complications and mean ASQ score at 6 and 18 months of age. Conclusion In high-risk twin pregnancies, progesterone treatment does not significantly improve outcome.

U2 - 10.1002/uog.9092

DO - 10.1002/uog.9092

M3 - Journal article

SN - 0960-7692

VL - 38

SP - 281

EP - 287

JO - Ultrasound in Obstetrics & Gynecology

JF - Ultrasound in Obstetrics & Gynecology

IS - 3

ER -