Clinical trial NCT02705248: Insulin Resistance in Recurrent Miscarriage
Official title: The Role of Insulin Resistance in Recurrent Miscarriage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant females in their first trimester (6- 13 weeks Gestational Age)

Brief summary: The objective of this study is to study the association between insulin resistance and recurrent spontaneous miscarriage (RSM).

Detailed description: This a case-control study which was performed during the period from (December 2013) till (June 2014). Researcher had 80 participants presented to the outpatient clinic in Ain Shams University Maternity hospital; they were classified into two groups: (Group A) case group: 40 pregnant females at 6- 13wks presenting with a history of recurrent pregnancy loss (two or more failed clinical pregnancies as documented by ultrasonography or histopathology examination according to the American Society of Reproductive Medicine). (Group B) control group: 40 pregnant females at 6- 13wks with no history of abortion. They were selected according to inclusion and exclusion criteria:

* Inclusion criteria:

  1. Women in the child bearing period between 23-40 years.
  2. All patients were pregnant.
  3. The gestational age of both groups 6-13 weeks(1st trimester)
* Exclusion criteria:

  1. Patients with history of gestational diabetes.
  2. The patients on medication that could affect glucose metabolism at the time of the study (as metformin, Pioglitazone,rosiglitazone).
  3. Patients with other causes of recurrent abortion as (thyroid dysfunction, uterine anomalies, chromosomal abnormalities, antiphospholipid antibody syndrome).
  4. Patients with PCOS in the control group (they have insulin resistance).
  5. Obese patients (BMI \>30).

The study was conducted after approval of the hospital ethical committee and a written consent was taken from all cases and controls participating in the study after full explanation. For all participants detailed history taking, full examination including body mass index was taken. The subjects were asked to go on a normal diet for 3 days prior to oral glucose tolerance test (OGTT). A fast for 8-10 h was required prior to sampling. A venous blood sample was drawn on the following morning from each subject to determine the concentrations of fasting glucose (FG) and fasting insulin (FI), afterwards subjects were required to drink a mixture of 75 g of pure glucose in 250 ml of water, venous blood samples were drawn again after 1, 2, and 3 h to determine the concentrations of glucose and insulin blood samples for determination of fasting glucose and fasting insulin after 8-10hours fasting and oral glucose tolerance test. Glucose concentration was determined using the hexokinase endpoint method; while insulin concentration was determined using the immunoluminescence method. The Immulite2000 Immunoassay Analyzer was used along with the necessary reagents. The homeostasis model assessment of insulin resistance index (HOMA-IR) for each subject was calculated as follows: \[FI (U/ ml) ×FG (mmol/l)\]/22.5.The larger the HOMA-IR, the more severe the degree of IR. HOMA-B, which represents the endocrine function of insulin, is calculated as 20× FI/ (FG-3.5). I 60 /I 0 represent the rate of 1-hour insulin to 1-hour glucose, and I60 / G60 represent the rate of 1-hour insulin increase to 1-hour glucose increase. Both values reflect the endocrine functions of B cells of the pancreatic gland. The area under the curve of glucose (AUCG) is equal to half of the FG plus

1-hour glucose, 2-hour glucose, and half of the 3-hour glucose. The area under the curve of insulin (AUCI) is also computed in this manner for insulin. The ratio AUCI/AUCG represents the rate of AUCI to AUCG, and the higher the rate, the more severe the degree of IR.

Eligibility criteria: Inclusion Criteria:

1. Women in the child bearing period between 23-40 years.
2. All patients were pregnant.
3. The gestational age of both groups 6-13 weeks(1st trimester)

Exclusion Criteria:

1. Patients with history of gestational diabetes.
2. The patients on medication that could affect glucose metabolism at the time of the study (as metformin, Pioglitazone,rosiglitazone).
3. Patients with other causes of recurrent abortion as (thyroid dysfunction, uterine anomalies, chromosomal abnormalities, antiphospholipid antibody syndrome).
4. Patients with PCOS in the control group (they have insulin resistance).
5. Obese patients (BMI \>30).

Primary outcomes:
measure: insulin resistance in patients with recurrent miscarriage
timeFrame: first trimester of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Tarek M Tamara, Dr
role: STUDY_DIRECTOR
References: