Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2026-02-22 @ 4:07 AM
Study NCT ID:
NCT02315820
Status:
UNKNOWN
Last Update Posted:
2014-12-12
First Post:
2014-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Trial
Sponsor:
The Baruch Padeh Medical Center, Poriya
Organization:
Study Overview
Official Title:
Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2014-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IOLEMMT
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: