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Completed

NCT Number: NCT03841591

Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high cost. Metformin, an oral biguanide, may be a more logical alternative to insulin for women with GDM who are unable to cope with the increasing insulin resistance of pregnancy.

This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

19 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ain SHams Maternity Hospital

Cairo, Abbaseya, 002, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged (19-35) years
  • BMI 18-30 kg/m2
  • Gestational age >24 weeks
  • Singleton pregnancy
  • Gestational diabetes mellitus with failure to achieve adequate glucose control on diet therapy alone (FBG > 105) OR patients with gestational diabetes who are controlled with either metformin alone or insulin alone.

Exclusion criteria

  • Pregnant women with preexisting diabetes mellitus
  • Women who have contraindication to take metformin e.g.: impaired renal function, hepatic cirrhosis, hepatitis).
  • Patients with other medical disorders that could affect perinatal outcome (e.g., hypertension, SLE etc).
  • Fetal anomalies identified on ultrasound prior to initiation of therapy.
  • Patients who refused to participate

Treatment and study plan

Insulin

Drug

Women with GDM will receive insulin and tailored according to their blood glucose levels to achieve glycemic control. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.

metformin

Drug

Women with GDM will receive metformin and tailored according to their blood glucose levels to achieve glycemic control. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.

Other names: Cidophage

Assessment of weight gain

Other

Body weight will be measured monthly from the start of treatment till delivery.

Primary outcomes

  1. Rate of maternal weight gain per week

    Time frame: 4 months

    Maternal weight (in grams) will be measured monthly. Difference in measured weight between starting treatment and delivery will be divided by the number of weeks.

Secondary outcomes

  1. 1-min APGAR score

    Time frame: 1 minute

    APGAR score at minute 1 after delivery

  2. 5-min APGAR score

    Time frame: 5 minutes

    APGAR score at minute 5 after delivery

  3. Incidence of neonatal hypoglycemia

    Time frame: 1 day

    Number of neonates with two or more neonatal glucose value <2.6 mmol per liter during the first day after delivery.

  4. Incidence of neonatal respiratory distress

    Time frame: 1 day

    Number of neonates needing at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or intermittent positive-pressure ventilation during the first 24 hours after delivery.

  5. Incidence of macrosomia

    Time frame: 1 hour

    Number of neonates with birth weight greater than 4000 g or greater than 90% for gestational age

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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