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
About this trial
This is an interventional prevention trial for Macrosomia focused on measuring Macrosomia, Induction of labor, Expectant management, Shoulder dystocia
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.
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
NCT ID
NCT02315820
First Posted
December 7, 2014
Last Updated
December 10, 2014
Sponsor
The Baruch Padeh Medical Center, Poriya
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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