Induction Versus Expectant Management With Abnormal Maternal Biochemical Markers

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

Detailed Description
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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.

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

Conditions
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PREGNANCY

Intervention / Treatment
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* Other: Induction of labour
* Other: Expectant management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Induction of labour<br>Induction of labour at 38-39 weeks | Other: Induction of labour<br>* Induction of labour<br>|
| Active Comparator: Expectant management<br>Expectant management until 41 weeks. | Other: Expectant management<br>* Expectant management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placental abruption | Clinical diagnosis. Co-primary endpoint #1. | 4 weeks | 
| Gestational hypertension | Blood pressure above 140/90 mmHg. Co-primary endpoint #2 | 4 weeks | 
| Small of gestational age | Birth Weight less than the 10th percentile. Co-primary endpoint #3 | 4 weeks | 
| Intra-uterine death | Fetal death. Co-primary endpoint #4 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery | vaginal or cesarean. | 4 weeks | 
| Intrapartum fever | fever above 38C | 4 weeks | 
| Neonatal Apgar score | Apgar score | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abnormal first or second trimester biochemical markers, maternal and perinatal morbidity/mortality