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Maternal Risk Factors That Could Predict Hypoglycemia in Newborns

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Silvia Hoirisch Clapauch, Hospital dos Servidores do Estado do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01409382
First received: May 27, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

Neonatal hypoglycemia is related to learning disabilities and epilepsy. Maternal pancreas can be unable to respond to hyperglycemia, by producing insufficient insulin. The result will be gestational diabetes. When the response is adequate, insulin and proinsulin are synthesized to face metabolic requirements. Proinsulin stimulates plasminogen activator inhibitor 1, creating a prothrombotic environment. As a consequence, regional end organ thrombotic phenomena tends to occur. Placental thrombosis restricts fetal growth, turning macrosomic fetuses into adequate for gestational age. Fetal metabolic response to hyperglycemia is adequate: these fetuses are hyperinsulinemic and after birth are at higher risk for hypoglycemia.


Condition Intervention
Hyperinsulinemia
Insulin Resistance
Pregnancy
Sedentary Lifestyle
Hypoglycemia
 Behavioral: Daily brisk walking plus a carbohydrate-restricted diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: 1. Neonatal Hypoglycemia: a Risk Factor Analysis 2. Impact of Lifestyle Modification on Neonatal Hypoglycemia and Other Adverse Obstetric Outcomes Related to Maternal Hyperinsulinemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital dos Servidores do Estado do Rio de Janeiro:

Primary Outcome Measures:
  • Neonatal glycemia equal or bellow 40mg/dL [ Time Frame: One hr, 2hr and 4hr immediately after birth. ] [ Designated as safety issue: Yes ]
    Capillary glycemia will be checked at 1hr, 2hr and 4hr immediately after birth to detect and treat hypoglycemia, as defined as glycemic levels equal or bellow 40mg/dL


Secondary Outcome Measures:
  • Refractory hypoglycemia [ Time Frame: One hr, 2hr, and 4hr immediately after birth ] [ Designated as safety issue: No ]
    If capillary glycemia is equal or bellow 40mg/dL, milk is offered or intravenous dextrose is infused during one hr. A new capillary glycemia is checked. If capillary glycemia is equal or bellow 40mg/dL then it is considered refractory hypoglycemia.


Other Outcome Measures:
  • Prevention of neonatal hypoglycemia and adverse pregnancy outcomes [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Patients will be randomized to regular care or to a protocol combining daily brisk walking plus a carbohydrate controled diet.


Estimated Enrollment: 1000
Study Start Date: April 2011
Estimated Study Completion Date: April 2015
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lifestyle counseling
Daily brisk walking plus a carbohydrate-restricted diet
 Behavioral: Daily brisk walking plus a carbohydrate-restricted diet
Daily brisk walking plus a carbohydrate-restricted diet Mothers will be highly recommended to engage in brisk walking at moderate speed (4 km/h) for at least 40 minutes per day, 7/7 and will be told to increase substantially the protein content of their meals (at least 300 g per day of meat, poultry or fish), with the objective to induce satiety, and reduce both food craving and consumption of carbohydrate-rich meals (sugar or honey in food or beverages, white rice, potato, cereals, bread, cookies, crackers, pasta and other food containing white flour). Recommendations will be repeated with emphasis at every appointment.
Placebo Comparator: Standard follow-up
Prenatal care will proceed according to the routine. Controls were advised to avoid both bed rest and unhealthy food

Detailed Description:

Eligibility criteria: non diabetic mothers with insulin resistance markers and their babies Our aim is to study maternal characteristics related to insulin resistance relating to newborn outcome.

Maternal characteristics include: age, race, parity, previous obstetric outcome, dietary pattern 24hs before delivery (12-hour fast/0, strict diet/1, balanced diet/2, carbohydrate excess/3, carbohydrate abuse/4), more or less than 40 minutes brisk walking 48 hs before delivery, cervical acanthosis (quantifying cervical lesion color as 1+ faint/2+ clear/3+ dark and visible from distance/4+ charcoal black), hypertriglyceridemia during the 1st trimester or prepregnancy and close to delivery, proteinuria close to delivery, weight gain until and after the 32nd week, infection during the week before delivery, how many days before delivery admission occurred, how many days before delivery the mother remained in bed, did preeclampsia or eclampsia occurred, continuous or parenteral corticosteroid use, beta-blocker use.

Newborn outcome include: Weight, height, Ballard, glycemia after 1,2 and 4hs, brachial diameter, tricipital skin-fold.

We have identified that only two risk factors could predict neonatal hypoglycemia: excessive carbohydrate consumption and maximum rest increased the risk for neonatal hypoglycemia OR=329 (95%CI: 32-3362, P<0.001) compared to no risk factors. Preliminary analysis indicated that the group of mothers who reported excessive carbohydrate intake and maximum rest had a high risk for preeclampsia, gestational diabetes and early pregnancy losses, we decided to randomize 182 patients to daily brisk walking plus a carbohydrate-restricted diet or to a control group.

  Eligibility

Ages Eligible for Study:   up to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • medium or dark brown acanthosis nigricans,
  • less than 40 minutes walking during 48 hours preceding delivery,
  • infection during the week that preceded delivery,
  • corticosteroid use during the week preceding delivery
  • excessive carbohydrate intake within 24 hours before delivery
  • ≥1,5 kg/per month at or after the 32nd gestational week
  • BMI >30 kg/sqm
  • large for gestational age newborns
  • maternal diabetes (type 1, type 2 or gestational diabetes)
  • recurrent miscarriages

Exclusion Criteria:

- refuse to sign the informed consent

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409382

Locations
Brazil
Hospital dos Servidores do Estado
Rio de Janeiro, RJ, Brazil, 20221-903
Sponsors and Collaborators
Hospital dos Servidores do Estado do Rio de Janeiro
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
Principal Investigator: Maria A Sayeg-Porto, MD, DSc Hospital dos Servidores do Estado, RJ; Universidade Federal do Rio de Janeiro
Principal Investigator: Paulo R Benchimol-Barbosa, MD, DSc Universidade Gama Filho; COPPE/UFRJ
Principal Investigator: Silvia Hoirisch-Clapauch, MD Hospital dos Servidores do Estado, RJ
  More Information

No publications provided

Responsible Party: Silvia Hoirisch Clapauch, Principal investigator, Hospital dos Servidores do Estado do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01409382     History of Changes
Other Study ID Numbers: 000416-09-08-2010
Study First Received: May 27, 2011
Last Updated: April 22, 2013
Health Authority: Brazil: Local Ethics Committee
United States: Federal Government

Keywords provided by Hospital dos Servidores do Estado do Rio de Janeiro:
neonatal hypoglycemia
insulin resistance
acanthosis nigricans
 sedentary lifestyle
excessive carbohydrate consumption
obesity

Additional relevant MeSH terms:
Hyperinsulinism
Hypoglycemia
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013