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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

Effect of Adding Metformin to Insulin Therapy on Pregnancy Outcomes in Women With Uncontrolled Type I Diabetes.

Clinicaltrials.gov identifier NCT03928340

Recruitment Status Completed

First Posted April 26, 2019

Last update posted May 28, 2020

Study Description

Brief summary:

A randomized controlled clinical trial will be conducted in KasrELAiny hospitals, Cairo University and Beni-Suef University Hospital, including 80 uncontrolled diabetic pregnant women (type I) in the 3rd trimester (28-32 weeks of pregnancy) divided equally into study group and control group, to compare the usage of both metformin and insulin instead of using insulin alone. Group assignment will be randomized by computer program.

  • Condition or Disease:Type1 Diabetes Mellitus
  • Intervention/Treatment: Drug: Metformin
    Drug: Insulin
  • Phase: Phase 4
Detailed Description

A total of 80 uncontrolled diabetic pregnant patients in the 3rd trimester seeking medical advice in Beni-Suef University Hospital and meet the eligibility criteria, are approached about participation in the trial and given information pamphlets describing the study. The patients are asked to sign a consent form and will be assigned to one of the 2 groups: Group A (study group); will include 40 patients who will be treated with metformin (1 gm twice daily (with the 2 main meals)), combined with insulin therapy Group B (control group); will include 40 patients who will be treated with insulin alone. (Insulin dosage will be adjusted according to endocrinological recommendations) All patients will be managed according to NICE guidelines for diabetes with pregnancy (2015) Maternal assessment - Full history taking Baseline medical history is obtained along with other baseline demographics and concomitant medications including insulin regimen and dose. - Thorough clinical examination Maternal weight, height and blood pressure measured and recorded. - Laboratory investigations; - Routine labs: CBC, coagulation profile, liver and kidney function at time of participation, 28-32 weeks of gestation especially renal parameter serum Creatinine. - HbA1c at time of 1st examination. - FBS, 2h post prandial blood sugar will be done weekly from time of participation till time of delivery - Fundus examination for early detection of retinal affection at Ophthalmology clinic Follow up: 1. Fetal weight gain weekly 2. Maternal weight gain weekly Accordingly: 1. Uncontrolled cases will follow up weekly in the High Risk Pregnancy outpatient clinic until 36 weeks and then admitted to High risk pregnancy department for termination of pregnancy o Fetal surveillance will be done by ;CTG weekly, Ultrasound weekly and Fetal kick count daily 2. Resistant uncontrolled cases will be admitted to high risk pregnancy department where capillary blood sugar will be measured 7 times daily Fetal surveillance will be done by ; CTG Daily, Ultrasound every 3 days and Fetal kick count daily Assessment of Patients at time of termination by: 1. Fasting blood sugar , 2 hours post prandial blood sugar and HBA1C 2. Routine preoperative labs. CBC, coagulation profile, liver and kidney function 3. Fetal weight 4. Maternal weight Neonatal assessment after delivery include the following; APGAR score, neonatal weight, incidence of transient tachypnea of newborn (TTN), acute respiratory distress syndrome (ARDS), neonatal hypoglycemia and NICU admission.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 80 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Effect of Adding Metformin to Insulin Therapy in Pregnant Women With Type I Diabetes as Regards Pregnancy Outcome
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: March 2020
  • Actual Study Completion Date: March 2020
Arms and interventions
Arm Intervention/treatment
Active Comparator: combined metformin and insulin
Drug: Metformin
40 patients will be treated with metformin (1 gm twice daily (with the 2 main meals)), combined with insulin therapy

Drug: Insulin
40 patients will be treated with insulin alone. (Insulin dosage will be adjusted according to endocrinological recommendations)
Other: Insulin only
Drug: Insulin
40 patients will be treated with insulin alone. (Insulin dosage will be adjusted according to endocrinological recommendations)
Outcome Measures
  • Primary Outcome Measures: 1. HbA1c [ Time Frame: 12 weeks ]
    the change in level of glycosylated haemoglobin
  • 2. capillary glucose [ Time Frame: 12 weeks ]
    the change in level of glucose in capillary blood
  • 3. fasting blood sugar measurement. [ Time Frame: 12 weeks ]
    the change in level of glucose in venous blood after fasting for 8 hours
  • 4. 2 hours post prandial blood sugar measurement. [ Time Frame: 12 weeks ]
    the change in level of glucose in venous blood 2 hours after meal
  • Secondary Outcome Measures: 1. Maternal weight gain [ Time Frame: 12 weeks ]
    the change in mothers' weight in kilograms
  • 2. weekly fetal weight gain measured by ultrasound [ Time Frame: 12 weeks ]
    the change of fetal weight measured by ultrasound
  • 3. insulin requirements [ Time Frame: 12 weeks ]
    the change in dose of insulin taken by patient
  • 4. attacks of maternal hypoglycemia [ Time Frame: 12 weeks ]
    Number of patients with plasma glucose level below 65 mg/dl
  • 5. intra uterine fetal death (IUFD) [ Time Frame: 12 weeks ]
    The number of patients with death of fetus after 20 weeks of gestation
  • 6. neonatal weight [ Time Frame: 12 weeks ]
    The change in neonatal weight in kilograms
  • 7. preterm birth [ Time Frame: 12 weeks ]
    The number of patients giving birth berfore 37 completed weeks
  • 8. neonatal respiratory distress [ Time Frame: 12 weeks ]
    the number of neonates with neonatal respiratory distress
  • 9. neonatal hypoglycemia [ Time Frame: 12 weeks ]
    the number of neonates with plasma glucose level below less than 45 mg/dL (2.5 mmol/L)
  • 10. neonatal Intensive care admission [ Time Frame: 12 weeks ]
    the number of neonates with neonatal Intensive care admission
Eligibility Criteria
  • Ages Eligible for Study: 18 to 45 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Diabetic pregnant patients with type one diabetes and no other chronic disorders

- Patients on insulin in the 3rd trimester of pregnancy (on insulin therapy since start
of gestation)

- Patients pregnant in single living fetus with no apparent congenital anomalies

- Haemoglobin A 1 C (HbA1c) level between 7% to 11%

- All patients have done a dating ultrasound to confirm gestational age, viability and
rule out any abnormality

Exclusion Criteria:

- Patients with type 2 or gestational diabetes

- Patients with intolerance or hypersensitivity to metformin

- Patients with congestive heart failure or a history of congestive heart failure

- Patients with renal insufficiency

- Patients having current significant gastrointestinal problems such as severe vomiting
requiring intravenous fluids or hospitalization

- Presence of acute or chronic metabolic acidosis, including diabetic ketoacidosis, a
history of diabetic ketoacidosis or history of lactic acidosis

- Patients with liver impairment

- Patients with known higher order pregnancies (twins, triplets, etc.)

- Patients having a known potentially fetal lethal anomaly

Contacts and Locations
Contacts
Locations

Egypt
Beniswef university hospital
Cairo

Sponsors and Collaborators

Kasr El Aini Hospital

Amal Kotb Abdallah

Amir Gabr

Mohamed Abdeltawwab Mahmoud

Investigators

Principal Investigator: Amal kotb Beniswef university hospital

Principal Investigator: Amir Gabr Cairo university kasrelainy hospitals

More Information
  • Responsible Party: Kasr El Aini Hospital
  • ClinicalTrials.gov Identifier: NCT03928340 History of Changes
  • Other Study ID Numbers: FMBSUREC/05032019/Abd Alaziz
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: May 28, 2020
  • Last Verified: May 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Diabetes Mellitus Diabetes Mellitus, Type 1