NCT02754635

Induction Versus Expectant Management With Abnormal Maternal Biochemical Markers

Induction of Labor at Term Versus Expectant Management Among Women With Abnormal Maternal Serum Biochemical Markers: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• PREGNANCY

Interventions

Type	Name	Description
OTHER	Induction of labour	Induction of labour
OTHER	Expectant management	Expectant management

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-05-01
• Completion: 2018-07-01
• First posted: 2016-04-28
• Last updated: 2017-08-16

Locations

1 site across 1 country: Israel