Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Trial (IOLEMMT)
|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
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||474 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Rate of shoulder dystocia [ Time Frame: 3 years ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315820
|Contact: Yuri Perlitz, MDemail@example.com|
|Contact: Tal Bouganim, MDfirstname.lastname@example.org|
|Principal Investigator:||Yuri Perlitz, MD||Director-High risk unit and maternal department|