PREGNANCY
Conditions
Keywords
Abnormal first or second trimester biochemical markers, maternal and perinatal morbidity/mortality
Brief summary
Induction of labor at term versus expectant management among women with abnormal maternal biochemical markers. A randomized controlled trial
Detailed description
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.
Interventions
OTHERInduction of labour
Induction of labour
OTHERExpectant management
Expectant management
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* HCG, AFP or Inhibin greater than 2 multiple of median (MOM) or PAPPA less than 0.15 MOM. * Singleton. * Appropriate for gestational age fetus. * Reassuring fetal status including normal amniotic fluid index.
Exclusion criteria
* Any hypertensive disorder. * Indication for induction of labour at enrollment. * Any contraindication of induction of labour. * Prior cesarean delivery. * Any contraindication for a trial of vaginal delivery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Placental abruption | 4 weeks | Clinical diagnosis. Co-primary endpoint #1. |
| Gestational hypertension | 4 weeks | Blood pressure above 140/90 mmHg. Co-primary endpoint #2 |
| Small of gestational age | 4 weeks | Birth Weight less than the 10th percentile. Co-primary endpoint #3 |
| Intra-uterine death | 4 weeks | Fetal death. Co-primary endpoint #4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of delivery | 4 weeks | vaginal or cesarean. |
| Intrapartum fever | 4 weeks | fever above 38C |
| Neonatal Apgar score | 4 weeks | Apgar score |
Countries
Israel
Outcome results
None listed