Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Trial
IOLEMMT
1 other identifier
interventional
474
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2014
CompletedFirst Posted
Study publicly available on registry
December 12, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedDecember 12, 2014
December 1, 2014
3.9 years
December 7, 2014
December 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of shoulder dystocia
3 years
Secondary Outcomes (1)
Neonatal morbidity composite outcome and maternal morbidity composite outcome.
3 years
Study Arms (2)
Induction of Labor (IOL)
EXPERIMENTALGroup I, Induction of Labor group (IOL). Women will be admitted for induction at 38-40+3 weeks when estimated fetal weight 3800-4500 gram.
Expectant
NO INTERVENTIONGroup II. Will be expectantly managed until 40+6 weeks, or an induction indication will appear.
Interventions
Women at 38-40+3 weeks with estimated fetal weight 3800-4500 will be offered ripening and IOL.
Eligibility Criteria
You may qualify if:
- Singleton,
- live fetus,
- Vx presentation,
- EFW 3800-4500 grams,
- eligible for vaginal delivery,
- signed the informed consent.
You may not qualify if:
- Pr. CS,
- Diabetes,
- fetal major malformations,
- maternal/fetal illness or condition requiring IOL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Boulvain M, Thornton JG. Induction of labour at or near term for suspected fetal macrosomia. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD000938. doi: 10.1002/14651858.CD000938.pub3.
PMID: 36884238DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuri Perlitz, MD
Director-High risk unit and maternal department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director-High Risk Unit & Maternitiy department
Study Record Dates
First Submitted
December 7, 2014
First Posted
December 12, 2014
Study Start
January 1, 2015
Primary Completion
December 1, 2018
Study Completion
July 1, 2019
Last Updated
December 12, 2014
Record last verified: 2014-12