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

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ClinicalTrials.gov Identifier: NCT02315820
Recruitment Status : Unknown
Verified December 2014 by Yuri perlitz, The Baruch Padeh Medical Center, Poriya.
Recruitment status was:  Not yet recruiting
First Posted : December 12, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Yuri perlitz, 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.


Condition or disease Intervention/treatment Phase
Macrosomia Induction of Labor Expectant Management Shoulder Dystocia Procedure: Induction of labor group (Group I) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Randomized Trial
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Expectant
Group II. Will be expectantly managed until 40+6 weeks, or an induction indication will appear.



Primary Outcome Measures :
  1. Rate of shoulder dystocia [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Neonatal morbidity composite outcome and maternal morbidity composite outcome. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315820


Contacts
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Contact: Yuri Perlitz, MD +972-50-6267439 yperlitz@poria.health.gov.il
Contact: Tal Bouganim, MD +972-52-430-3840 tbouganim@poria.health.gov.il

Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Investigators
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Principal Investigator: Yuri Perlitz, MD Director-High risk unit and maternal department

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Responsible Party: Yuri perlitz, Director-High Risk Unit & Maternitiy department, The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier: NCT02315820     History of Changes
Other Study ID Numbers: POR-0085-14
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by Yuri perlitz, The Baruch Padeh Medical Center, Poriya:
Macrosomia
Induction of labor
Expectant management
Shoulder dystocia

Additional relevant MeSH terms:
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Dystocia
Fetal Macrosomia
Obstetric Labor Complications
Pregnancy Complications
Diabetes, Gestational
Fetal Diseases
Pregnancy in Diabetics
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Birth Weight
Body Weight
Signs and Symptoms