Induction of Labor Clinical Trial
Official title:
Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Randomized Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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