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

Not Applicable

• Conditions: Expectant Management; Macrosomia; Induction of Labor; Shoulder Dystocia
• Interventions: Procedure: Induction of labor group (Group I)

• Registration Number: NCT02315820
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

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.

Study Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-07
• Study First Submitted QC: 2014-12-10
• Last Update Submitted: 2014-12-10
• Study First Posted: 2014-12-12
• Last Update Posted: 2014-12-12
• Study Start: 2015-01
• Primary Completion: 2018-12
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 474

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Induction of Labor (IOL)	Induction of labor group (Group I)	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.

Primary Outcome Measures

Name	Time	Method
Rate of shoulder dystocia	3 years

Secondary Outcome Measures

Name	Time	Method
Neonatal morbidity composite outcome and maternal morbidity composite outcome.	3 years	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.