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Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Trial (IOLEMMT)

Primary Purpose

Macrosomia, Induction of Labor, Expectant Management

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Induction of labor group (Group I)
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Macrosomia focused on measuring Macrosomia, Induction of labor, Expectant management, Shoulder dystocia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Singleton,
  • live fetus,
  • Vx presentation,
  • EFW 3800-4500 grams,
  • eligible for vaginal delivery,
  • signed the informed consent.

Exclusion Criteria:

  • Pr. CS,
  • Diabetes,
  • fetal major malformations,
  • maternal/fetal illness or condition requiring IOL.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Induction of Labor (IOL)

    Expectant

    Arm Description

    Group I, Induction of Labor group (IOL). Women will be admitted for induction at 38-40+3 weeks when estimated fetal weight 3800-4500 gram.

    Group II. Will be expectantly managed until 40+6 weeks, or an induction indication will appear.

    Outcomes

    Primary Outcome Measures

    Rate of shoulder dystocia

    Secondary Outcome Measures

    Neonatal morbidity composite outcome and maternal morbidity composite outcome.
    For each study group a neonatal and maternal composite outcome will be presented. The neonatal composite outcome will include: Fetal death (before the onset of labor, during delivery, unknown), Neonatal death, Birth weight (grams), Apgar score 1 min, Apgar score 5 min, Cord PH, Shoulder dystocia, Erb palsy, 3rd/4th-degree lacerations, Intubation, CPAP or high-flow nasal cannula (HFNC) for ventilation. Neonatal encephalopathy, Seizures, Sepsis, Pneumonia, Meconium aspiration syndrome, Birth fractures, IVH, Hyperbilirubinemia requiring phototherapy or exchange transfusion. Hypoglycemia (gl<40) requiring IV therapy. Admission to NICU, Neonatal hospital stay. The maternal morbidity composite outcome will include: Chorioamnionitis PPH Maternal febrile morbidity requiring antibiotics administration. Anemia requiring blood transfusion.

    Full Information

    First Posted
    December 7, 2014
    Last Updated
    December 10, 2014
    Sponsor
    The Baruch Padeh Medical Center, Poriya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02315820
    Brief Title
    Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Trial
    Acronym
    IOLEMMT
    Official Title
    Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    July 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Baruch Padeh Medical Center, Poriya

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The equipoise whether to Induce pregnant women with suspected large for gestational babies or suspected macrosomia babies at term pregnancy is not solved yet. Only 2 relatively small studies were conducted to answer this clinically important question. The investigators will conduct a randomized controlled, multi-center study large enough to confirm or refute our assumption that induction of labor at term reduces the shoulder dystocia prevalence significantly compared to expectant management.
    Detailed Description
    Background: Macrosomia at term is associated with increased maternal and neonatal morbidity, including a higher rate of shoulder dystocia and cesarean section (CS). Induction of labor (IOL) has been suggested as a means to prevent further fetal weight gain and therefore to reduce possible neonatal and maternal complications which are related to fetal weight. Working hypothesis and aims: The aims of this study are: 1) to determine whether or not IOL improves maternal and neonatal outcome in large for gestational age babies, 2) to determine maternal satisfaction from the labor and delivery process in both study groups. Our working hypothesis is that IOL will reduce the shoulder dystocia and CS rate of LGA\macrosomic babies at term. Methods: Patient from 38+0 - 40+3 gestational weeks estimated fetal weight 3800 - 4500 gr will prospectively and randomly allocated into two groups: IOL (group I) and expectant management (group II). Women with diabetes, a previous cesarean delivery, or other contraindications for vaginal delivery or candidates for IOL for other reasons will be excluded from the study. Outcome variables will include shoulder dystocia, brachial plexus injury, bone fractures, cephalhematoma, intraventricular hemorrhage, cesarean delivery and other neonatal and maternal variables. Expected results: IOL will reduce the shoulder dystocia and CS rate of LGA\macrosomic babies at term. Importance: This randomized, prospective multicenter study addresses a prevalent clinical question which does not have an accurate answer in the medical literature. Current guidelines rely on small numbered patients, and are over 15 years old studies. Probable implications to Medicine: This study will establish the right management for LAG\macrosomic babies at term, IOL or expectant management for spontaneous labor.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Macrosomia, Induction of Labor, Expectant Management, Shoulder Dystocia
    Keywords
    Macrosomia, Induction of labor, Expectant management, Shoulder dystocia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    474 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Induction of Labor (IOL)
    Arm Type
    Experimental
    Arm Description
    Group I, Induction of Labor group (IOL). Women will be admitted for induction at 38-40+3 weeks when estimated fetal weight 3800-4500 gram.
    Arm Title
    Expectant
    Arm Type
    No Intervention
    Arm Description
    Group II. Will be expectantly managed until 40+6 weeks, or an induction indication will appear.
    Intervention Type
    Procedure
    Intervention Name(s)
    Induction of labor group (Group I)
    Intervention Description
    Women at 38-40+3 weeks with estimated fetal weight 3800-4500 will be offered ripening and IOL.
    Primary Outcome Measure Information:
    Title
    Rate of shoulder dystocia
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Neonatal morbidity composite outcome and maternal morbidity composite outcome.
    Description
    For each study group a neonatal and maternal composite outcome will be presented. The neonatal composite outcome will include: Fetal death (before the onset of labor, during delivery, unknown), Neonatal death, Birth weight (grams), Apgar score 1 min, Apgar score 5 min, Cord PH, Shoulder dystocia, Erb palsy, 3rd/4th-degree lacerations, Intubation, CPAP or high-flow nasal cannula (HFNC) for ventilation. Neonatal encephalopathy, Seizures, Sepsis, Pneumonia, Meconium aspiration syndrome, Birth fractures, IVH, Hyperbilirubinemia requiring phototherapy or exchange transfusion. Hypoglycemia (gl<40) requiring IV therapy. Admission to NICU, Neonatal hospital stay. The maternal morbidity composite outcome will include: Chorioamnionitis PPH Maternal febrile morbidity requiring antibiotics administration. Anemia requiring blood transfusion.
    Time Frame
    3 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Singleton, live fetus, Vx presentation, EFW 3800-4500 grams, eligible for vaginal delivery, signed the informed consent. Exclusion Criteria: Pr. CS, Diabetes, fetal major malformations, maternal/fetal illness or condition requiring IOL.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuri Perlitz, MD
    Phone
    +972-50-6267439
    Email
    yperlitz@poria.health.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tal Bouganim, MD
    Phone
    +972-52-430-3840
    Email
    tbouganim@poria.health.gov.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuri Perlitz, MD
    Organizational Affiliation
    Director-High risk unit and maternal department
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Trial

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