Induction of Labor at Term Versus Expectant Management Among Women With Abnormal Maternal Serum Biochemical Markers: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Placental abruption
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
Induction of labour
Induction of labour at 38-39 weeks
Intervention: Induction of labour (Other)
Expectant management
Expectant management until 41 weeks.
Intervention: Expectant management (Other)
Outcomes
Primary Outcomes
Placental abruption
Time Frame: 4 weeks
Clinical diagnosis. Co-primary endpoint #1.
Gestational hypertension
Time Frame: 4 weeks
Blood pressure above 140/90 mmHg. Co-primary endpoint #2
Small of gestational age
Time Frame: 4 weeks
Birth Weight less than the 10th percentile. Co-primary endpoint #3
Intra-uterine death
Time Frame: 4 weeks
Fetal death. Co-primary endpoint #4
Secondary Outcomes
- Mode of delivery(4 weeks)
- Intrapartum fever(4 weeks)
- Neonatal Apgar score(4 weeks)
Investigators
Manal Massalha
Principal Investigator
HaEmek Medical Center, Israel