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

Induction of Labor Clinical Trial

— IOLEMMT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02315820
• Other study ID #: POR-0085-14
• Status: Not yet recruiting
• Phase: N/A
• First received: December 7, 2014
• Last updated: December 10, 2014
• Start date: January 2015
• Est. completion date: July 2019

Study information

• Verified date: December 2014
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: Yuri Perlitz, MD
• Phone: +972-50-6267439
• Email: yperlitz[@]poria.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 474
• Est. completion date: July 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dystocia
• Expectant Management
• Fetal Macrosomia
• Induction of Labor
• Macrosomia
• Shoulder Dystocia

Intervention

Procedure:
• Induction of labor group (Group I)
Women at 38-40+3 weeks with estimated fetal weight 3800-4500 will be offered ripening and IOL.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of shoulder dystocia		3 years	No
Secondary	Neonatal morbidity composite outcome and maternal morbidity composite outcome.	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.	3 years	No