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

NCT ID: NCT02315820

Last Updated: 2014-12-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-07-31

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.

Conditions

Macrosomia; Induction of Labor; Expectant Management; Shoulder Dystocia

Keywords

Macrosomia; Induction of labor; Expectant management; Shoulder dystocia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Induction of Labor (IOL)

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 Type: EXPERIMENTAL

Induction of labor group (Group I)

Intervention Type: PROCEDURE

Women at 38-40+3 weeks with estimated fetal weight 3800-4500 will be offered ripening and IOL.

Expectant

Group II. Will be expectantly managed until 40+6 weeks, or an induction indication will appear.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Induction of labor group (Group I)

Women at 38-40+3 weeks with estimated fetal weight 3800-4500 will be offered ripening and IOL.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yuri perlitz

Director-High Risk Unit & Maternitiy department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuri Perlitz, MD

Role: PRINCIPAL_INVESTIGATOR

Director-High risk unit and maternal department

Central Contacts

Yuri Perlitz, MD

Role: CONTACT

Phone: +972-50-6267439

Email: yperlitz@poria.health.gov.il

Tal Bouganim, MD

Role: CONTACT

Phone: +972-52-430-3840

Email: tbouganim@poria.health.gov.il

References

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.

Reference Type: DERIVED

PMID: 36884238 (View on PubMed)

Other Identifiers

POR-0085-14

Identifier Type: -

Identifier Source: org_study_id