Induction of labor at term versus expectant management among women with abnormal maternal biochemical markers. A randomized controlled trial
Pregnancy-associated plasma protein A (PAPP-A), alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), and inhibin A, are biochemical markers that are part of the first and second trimester screening test, for Down syndrome and neural tube defects in pregnancy. These biochemical markers have been shown also to be associated with slightly increased risk for adverse pregnancy outcomes in the absence of aneuploidy or neural tube defects, for example; preeclampsia, low birth weight, placental abruption, preterm labor, and intrauterine fetal death. There are no guidelines regarding the management of these cases assuming a reassuring maternal and fetal status are normal, at term (38 - 39 weeks). However, adverse events may still develop between 38 to 42 weeks when calculated according to ongoing pregnancy. Investigators aim in this randomized trial to examine the effect of induction of labor at 38 - 39 weeks compared to expectant management among women with abnormal first or second biochemical screening tests on maternal and perinatal outcomes. Enrollment: 320 women in both groups. Interim analyses will be performed after enrolling 50% of the participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
320
Induction of labour
Expectant management
Emek medical center
Afula, Israel
RECRUITINGPlacental abruption
Clinical diagnosis. Co-primary endpoint #1.
Time frame: 4 weeks
Gestational hypertension
Blood pressure above 140/90 mmHg. Co-primary endpoint #2
Time frame: 4 weeks
Small of gestational age
Birth Weight less than the 10th percentile. Co-primary endpoint #3
Time frame: 4 weeks
Intra-uterine death
Fetal death. Co-primary endpoint #4
Time frame: 4 weeks
Mode of delivery
vaginal or cesarean.
Time frame: 4 weeks
Intrapartum fever
fever above 38C
Time frame: 4 weeks
Neonatal Apgar score
Apgar score
Time frame: 4 weeks
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