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临床试验/CTRI/2024/06/069376
CTRI/2024/06/069376尚未招募4 期

Effect of antenatal Dexamethasone therapy on maternal blood glucose levels and fetal well being

Government medical college and hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年7月12日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
1) To study the effect of Dexamethasone therapy on maternal blood glucose levels

研究概览

简要总结

This study will be conducted in the Department of Obstetrics and Gynecology at Government Medical College and Hospital Chandigarh, focusing on pregnant women between 26-34 weeks of gestation with pre-term labor pains, premature rupture of membranes, and those who need cesarean section. Antenatal women will be recruited after informed consent and ethical clearance from the Institutional Ethics Committee. The study is a prospective observational study, with a sample size calculated based on 95% nondiabetic on glucocorticosteroids showing an increase in blood glucose levels above 140 mg/dl. The study includes pregnant women without diabetes and those planned for lower segment cesarean section (LSCS). Exclusion criteria include pregnant women with pre-existing diabetes and gestational diabetes mellitus, fetal growth restriction, patients requiring immediate termination of pregnancy or in established preterm labor, pregnant women with evidence of infection, chronic kidney disease, pre-existing adrenal and pancreatic dysfunction, tocolysis with beta-mimetic agents, and multifetal gestation. All patients visiting gynecological OPD and admitted to the labor room with the inclusion criteria will be enrolled after informed consent. Detailed demographic details, antenatal previous obstetrics, and medical history will be taken. A baseline general examination and obstetrical examination will be done before recruitment into the study. Routine blood samples will be taken, including complete blood count, renal function test, liver function test, c-reactive protein, and a vaginal swab for culture sensitivity if indicated. To exclude diabetes, random blood sugar will be tested in all recruited patients before starting Dexamethasone injection. Patients with a normal 75 gm glucose tolerance test (GTT) done between 24-28 weeks of gestation are included in the study. Dexamethasone dosage administration will be in the form of four doses of 6 mg separated by 12 hours intramuscularly. Baseline fetal movement count, nonstress test, biophysical profile, and umbilical artery Doppler flow will be studied before the administration of corticosteroid therapy.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1 Pregnant women between 26-34 weeks of gestation with threatened preterm labor pains and premature rupture of membranes 2 Antenatal women between 34-39 weeks planned for lower segment cesarean section (LSCS).

排除标准

  • Pregnant women with pre-existing diabetes and gestational diabetes mellitus.
  • Pregnant women with fetal growth restriction.
  • Patients who require immediate termination of pregnancy or are in established preterm labor.
  • Pregnant women with evidence of infection, where corticosteroid therapy may lead to flare-up of infection.
  • Patients with chronic kidney disease, and pre-existing adrenal and pancreatic dysfunction.
  • Pregnant women who have received tocolysis with beta-mimetic agents.
  • Multifetal gestation.

结局指标

主要结局

1) To study the effect of Dexamethasone therapy on maternal blood glucose levels

时间窗: 1) blood glucose level in antenatal women will be determined at baseline followed by 3 days of premeal and post meal blood sugar levels. | 2) fetal movements, biophysical profile, and umbilical artery Doppler will be done at baseline followed by 3 days of monitoring to study the effect of dexamethasone therapy on fetal well being.

in pregnant women without diabetes mellitus

时间窗: 1) blood glucose level in antenatal women will be determined at baseline followed by 3 days of premeal and post meal blood sugar levels. | 2) fetal movements, biophysical profile, and umbilical artery Doppler will be done at baseline followed by 3 days of monitoring to study the effect of dexamethasone therapy on fetal well being.

2) To study the fetal effects of antenatal Dexamethasone therapy including fetal movements, Biophysical profile, and Umbilical artery Doppler

时间窗: 1) blood glucose level in antenatal women will be determined at baseline followed by 3 days of premeal and post meal blood sugar levels. | 2) fetal movements, biophysical profile, and umbilical artery Doppler will be done at baseline followed by 3 days of monitoring to study the effect of dexamethasone therapy on fetal well being.

3)To assess the neonatal outcome of antenatal dexamethasone therapy

时间窗: 1) blood glucose level in antenatal women will be determined at baseline followed by 3 days of premeal and post meal blood sugar levels. | 2) fetal movements, biophysical profile, and umbilical artery Doppler will be done at baseline followed by 3 days of monitoring to study the effect of dexamethasone therapy on fetal well being.

 

时间窗: 1) blood glucose level in antenatal women will be determined at baseline followed by 3 days of premeal and post meal blood sugar levels. | 2) fetal movements, biophysical profile, and umbilical artery Doppler will be done at baseline followed by 3 days of monitoring to study the effect of dexamethasone therapy on fetal well being.

次要结局

未报告次要终点

研究者

发起方
Government medical college and hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr ADITI

government medical college sector 32 chandigarh

研究点 (1)

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