Clinical trial NCT06064552: Screening For First Trimester's Hyperglycemia in High and Low Risk Pregnancy
Official title: Screening For First Trimester's Hyperglycemia in High and Low Risk Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Screening for Hyperglycemia in First Trimester in High and Low Risk Pregnancy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: History of gestational diabetes in previous pregnancies

* Polycystic ovaries syndrome
* History of Macrosomic baby in previous pregnancies
* Past history of late third trimester fetal demise
* Past history of polyhydramnios
* Overweight /Obese women Women diagnosed to have other endocrinopathies like suprarenal, thyroid or pituitary disorders Multi fetal pregnancies Past history of shoulder dystocia Past history of preeclampsia Family history of diabetes

In addition, a comparable group of low-risk women will be included like primigravida healthy women or those with normal obstetric history.

Brief summary: Glucose intolerance is the commonest medical disorder complicating pregnancy. Hyperglycemia increases the risk of delivering a large for gestational age newborn (LGA) and related complications such as operative delivery, birth trauma and the poor adaptation of the newborn . Maternal risks of GDM include also polyhydramnios, preeclampsia, premature delivery, prolonged labor, uterine atony, postpartum hemorrhage, infection and progression of retinopathy which are the leading global causes of maternal morbidity and mortality .Detection of women at higher risk for GDM early in pregnancy is a desirable goal because interventions such as diet, medication, and exercise may be applied earlier in pregnancy and potentially can reduce later development of GDM or its associated morbidities. Most GDM cases are diagnosed after mid-gestation following an abnormal glucose challenge test (GCT). However, about 10% of patients with GDM can be diagnosed in the first trimester.


Eligibility criteria: Inclusion Criteria:

* • History of gestational diabetes in previous pregnancies

  * Polycystic ovaries syndrome
  * History of Macrosomic baby in previous pregnancies
  * Past history of late third trimester fetal demise
  * Past history of polyhydramnios
  * Overweight /Obese women Women diagnosed to have other endocrinopathies like suprarenal, thyroid or pituitary disorders Multi fetal pregnancies Past history of shoulder dystocia Past history of preeclampsia Family history of diabetes

In addition, a comparable group of low-risk women will be included like primigravida healthy women or those with normal obstetric history.

Exclusion Criteria:

* all patient not have thev inclusion criteria

Primary outcomes:
measure: blood sugar percentage
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: He XJ, Qin FY, Hu CL, Zhu M, Tian CQ, Li L. Is gestational diabetes mellitus an independent risk factor for macrosomia: a meta-analysis? Arch Gynecol Obstet. 2015 Apr;291(4):729-35. doi: 10.1007/s00404-014-3545-5. Epub 2014 Nov 12.
citation: Hadden DR, McLaughlin C. Normal and abnormal maternal metabolism during pregnancy. Semin Fetal Neonatal Med. 2009 Apr;14(2):66-71. doi: 10.1016/j.siny.2008.09.004. Epub 2008 Nov 4.
citation: Auvinen AM, Luiro K, Jokelainen J, Jarvela I, Knip M, Auvinen J, Tapanainen JS. Type 1 and type 2 diabetes after gestational diabetes: a 23 year cohort study. Diabetologia. 2020 Oct;63(10):2123-2128. doi: 10.1007/s00125-020-05215-3. Epub 2020 Jul 29.