Clinical trial NCT02754635: Induction Versus Expectant Management With Abnormal Maternal Biochemical Markers
Official title: Induction of Labor at Term Versus Expectant Management Among Women With Abnormal Maternal Serum Biochemical Markers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PREGNANCY
Keywords: Abnormal first or second trimester biochemical markers
maternal and perinatal morbidity/mortality
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Placental abruption
timeFrame: 4 weeks
measure: Gestational hypertension
timeFrame: 4 weeks
measure: Small of gestational age
timeFrame: 4 weeks
measure: Intra-uterine death
timeFrame: 4 weeks
Secondary outcomes:
measure: Mode of delivery
timeFrame: 4 weeks
measure: Intrapartum fever
timeFrame: 4 weeks
measure: Neonatal Apgar score
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek medical center
Study officials:
affiliation: Emek Medical Center
name: Raed Salim
role: STUDY_CHAIR
References:
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