Induction Versus Expectant Management With Abnormal Maternal Biochemical Markers

HaEmek Medical Center, Israel

Status: Unknown

Conditions: PREGNANCY

Treatments: Other: Expectant management; Other: Induction of labour

Study type: Interventional

Funder types: Other

Identifiers

NCT02754635

00126-15-EMC

Details and patient eligibility

About

Induction of labor at term versus expectant management among women with abnormal maternal biochemical markers. A randomized controlled trial

Full 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.

Enrollment: 320 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Induction of labour

Active Comparator group

Description:

Induction of labour at 38-39 weeks

Treatment:

Other: Induction of labour

Expectant management

Active Comparator group

Description:

Expectant management until 41 weeks.

Treatment:

Other: Expectant management