Induction Versus Expectant Management With Abnormal Maternal Biochemical Markers

Not Applicable

• Conditions: PREGNANCY
• Interventions: Other: Induction of labour; Other: Expectant management

• Registration Number: NCT02754635
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Study Timeline

• Study First Submitted: 2016-02-23
• Study Start: 2016-03
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-13
• Last Update Posted: 2017-08-16
• Primary Completion: 2018-05
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Induction of labour	Induction of labour	Induction of labour at 38-39 weeks
Expectant management	Expectant management	Expectant management until 41 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mode of delivery	4 weeks	vaginal or cesarean.
Intrapartum fever	4 weeks	fever above 38C
Neonatal Apgar score	4 weeks	Apgar score

Trial Locations

Locations (1)

Emek medical center; 🇮🇱 Afula, Israel