Clinical Trial: Effects of an Aquatic Physical Exercise Program on Glycaemic Control and Perinatal Outcomes of Gestational Diabetes: Study Protocol for a Randomized Controlled Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effects of an Aquatic Physical Exercise Program on Glycemic Control and Perinatal Outcomes of Gestational Diabetes - a Randomized Clinical Trial

Brief Summary: The purpose of this study is to verify the efficacy of an aquatic physical exercise program on GDM control and adverse maternal and fetal outcomes.

Detailed Summary:

Gestational diabetes mellitus (GDM) is increasing worldwide and has been associated with adverse perinatal outcomes and high risk for chronic disease both for the mother and for the child. Physical exercise is feasible to diabetic pregnant women and contributes to a better glycemic control and to decrease adverse perinatal outcomes. However there are no randomized controlled trials (RCT) assessing the effects of aquatic physical exercise on GDM control and adverse maternal and fetal outcomes.

A RCT will be conducted at Institute of Medicine Professor Fernando Figueira (IMIP), Brazil. IMIP is a reference hospital in the Northeast Brazil for mother and child care and performed about 6,000 deliveries per year. The recruitment of patients will focus on GDM women diagnosed at IMIP that referred to this center for treatment. Obstetrical staff will identify pregnant women recently diagnosed with GDM. These patients will be approached by a member of the study team and ask permission to be forwarded after an explanation of the study goals. GDM women will be considered eligible for enrollment if they fulfill all the inclusion criteria and none of the exclusion criteria. Interested patients will be invited to sign a written informed consent.

Sample size was calculated with the aim of reducing glucose levels by 20% in intervention group. A power of 80% and a level of significance of 5% was accepted and the calculated sample size in each arm was 30 patients. Assuming a drop out of 20%, 72 pregnant women will be included in the study. 36 gestational diabetics will develop an aquatic physical exercise program in a thermal pool, three times per week during two months, and 36 gestational diabetics will receive usual care from IMIP.

To ensure that similar guidelines for GDM clinical treatmen
Sponsor: Professor Fernando Figueira Integral Medicine Institute

Current Primary Outcome: Glycemic control [ Time Frame: one year ]

Blood glucose test: maternal glucose levels on third trimester of pregnancy and use of insulin

Use of insulin: need to use or not of insulin to control gestational diabetes mellitus. Variable nominal dichotomous yes / no.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Intra-uterus growth restriction (fetal ultrasound parameters) [ Time Frame: one year ]

    Intra-uterus growth restriction diagnosis will based on the following findings:

    birthweight percentile < 10 for gestational age, morphological ultrasound with Doppler (assessment of umbilical blood flow).

  • Prematurity [ Time Frame: one year ]
    Preterm birth (before 37th gestational week).
  • Newborns with macrosomia [ Time Frame: one year ]
    Cesarean section Birth injury Macrosomia (birth weight > 4,000g). Nominal variable, dichotomous yes or no.
  • Weight gain in pregnancy [ Time Frame: one year ]
    Weight measured at the end of pregnancy minus pre-pregnancy weight informed by pregnant woman (cm)
  • Maternal or neonatal intensive care admission [ Time Frame: one year ]
    Nominal variable, dichotomous yes or no.
  • Systolic and diastolic blood pressure [ Time Frame: one year ]
    Measured in mmHg every medical consultation
  • Preeclampsia diagnosis [ Time Frame: one year ]
    blood hypertension (levels of systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHglevels of systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg) associated with proteinuria
  • Cesarean section [ Time Frame: one year ]
    Nominal variable, dichotomous yes or no.
  • Birth injury [ Time Frame: one year ]
    Be will considered any kind of injury of the newborn occurred during delivery. Nominal variable, dichotomous yes or no.


Original Secondary Outcome: Same as current

Information By: Professor Fernando Figueira Integral Medicine Institute

Dates:
Date Received: August 23, 2013
Date Started: September 2013
Date Completion: December 2016
Last Updated: October 6, 2016
Last Verified: October 2016