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Induction Versus Expectant Management With Abnormal Maternal Biochemical Markers

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ClinicalTrials.gov Identifier: NCT02754635
Recruitment Status : Unknown
Verified August 2017 by Manal Massalha, HaEmek Medical Center, Israel.
Recruitment status was:  Recruiting
First Posted : April 28, 2016
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Manal Massalha, 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

Condition or disease Intervention/treatment Phase
PREGNANCY Other: Induction of labour Other: Expectant management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Induction of Labor at Term Versus Expectant Management Among Women With Abnormal Maternal Serum Biochemical Markers: A Randomized Controlled Trial
Study Start Date : March 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Active Comparator: Induction of labour
Induction of labour at 38-39 weeks
Other: Induction of labour
Induction of labour

Active Comparator: Expectant management
Expectant management until 41 weeks.
Other: Expectant management
Expectant management




Primary Outcome Measures :
  1. Placental abruption [ Time Frame: 4 weeks ]
    Clinical diagnosis. Co-primary endpoint #1.

  2. Gestational hypertension [ Time Frame: 4 weeks ]
    Blood pressure above 140/90 mmHg. Co-primary endpoint #2

  3. Small of gestational age [ Time Frame: 4 weeks ]
    Birth Weight less than the 10th percentile. Co-primary endpoint #3

  4. Intra-uterine death [ Time Frame: 4 weeks ]
    Fetal death. Co-primary endpoint #4


Secondary Outcome Measures :
  1. Mode of delivery [ Time Frame: 4 weeks ]
    vaginal or cesarean.

  2. Intrapartum fever [ Time Frame: 4 weeks ]
    fever above 38C

  3. Neonatal Apgar score [ Time Frame: 4 weeks ]
    Apgar score



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754635


Locations
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Israel
Emek medical center Recruiting
Afula, Israel, 18101
Contact: Raed Salim, MD    97246494031    salim_ra@clalit.org.il   
Principal Investigator: Manal Massalha, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Study Chair: Raed Salim Emek Medical Center
Publications of Results:

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Responsible Party: Manal Massalha, Principal Investigator, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02754635    
Other Study ID Numbers: 00126-15-EMC
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Manal Massalha, HaEmek Medical Center, Israel:
Abnormal first or second trimester biochemical markers
maternal and perinatal morbidity/mortality