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临床试验/NCT05182021
NCT05182021Unknown不适用

The Effect of Advanced Maternal Age on Pregnancy Outcomes: A Prospective Study

Mansoura University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Comparing the Obstetric outcomes as Gestational diabetes mellitus between the young and the elderly group

研究概览

简要总结

A prospective observational study of pregnancy outcomes at advanced maternal age among primigravida which include maternal ,fetal, obstetric and perinatal outcomes

详细描述

The investigator will have 2 groups of primigravida , the first group will be presented by 50 women aged 35 y or more and the second group will be presented by 50 women aged 20 y to 34 y The first group will be also divided into 2 subgroups : group (1A ) aged 35 y to 40 y and group (1B) aged above 40 y The investigator will compare the outcomes between the two group , also comparing the outcomes between women with spontaneous pregnancy and those using ART ( Assisted Reproductive Technology ) The participants will undergo routine investigations at the first antenatal visit and a monthly ultrasound examination until delivery The participants will be screened for gestational diabetes mellitus using oral glucose tolerance test between 24 :34 weeks of pregnancy The participants will be screened for gestational hypertension after 20 weeks of pregnancy Obstetric outcomes will be recorded regarding pregnancy induced hypertension, gestational diabetes mellitus , anemia, antepartum hemorrhage, obstetric shock and intrapartum hemorrhage Maternal outcomes will be recorded regarding mode of delivery ,time of delivery ,preterm labor ,obstructed labor and prolonged labor Fetal outcomes will be recorded regarding congenital malformation ,intra uterine growth retardation ,intra uterine fetal death and still birth Perinatal outcomes will be recorded regarded birth weight ,birth asphyxia , neonatal hypoglycemia ,hyperbilirubinemia and ICU admission

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • all primigravida women aged 20 to 34 years in control group and aged 35years or more in case group who seeking for antenatal care in mansoura university hospital and who accept study protocol

排除标准

  • multipara
  • women aged less than 20 years
  • women with any medical disorder ( anti phospholipid syndrome , chronic hypertension ,Diabetes, autoimmune disease and thrombosis embolic disease )

结局指标

主要结局

Comparing the Obstetric outcomes as Gestational diabetes mellitus between the young and the elderly group

时间窗: Between June 2021 to June 2022 and may be extended if needed

Gestational diabetes mellitus by using oral glucose tolerance test between 24 : 28 weeks of pregnancy (in mg/dl),

Comparing the Obstetric outcomes as Anemia between the young and the elderly group

时间窗: Between June 2021 to June 2022 and may be extended if needed

Detecting Anemia by measuring hemoglobin level (in gm/dl).

Comparing the Fetal outcomes of pregnancy between the young and the elderly group

时间窗: Between June 2021 to June 2022 and may be extended if needed

Fetal outcomes include: - Congenital malformation \& Intra uterine fetal death (detected by anomaly scan).

Comparing the Neonatal hypoglycemia between the young and the elderly group

时间窗: Between June 2021 to June 2022 and may be extended if needed

Detected by measuring neonatal blood glucose level (mg/dl).

Comparing the Obstetric outcomes as Oligohydramnios or polyhydramnios between the young and the elderly group

时间窗: Between June 2021 to June 2022 and may be extended if needed

Detected by measuring (amniotic fluid index in cm) by ultrasound.

Comparing the Perinatal outcomes as Birth weight between the young and the elderly group

时间窗: Between June 2021 to June 2022 and may be extended if needed

Birth weight (in gm).

Comparing the Maternal outcomes as Preterm labor between the young and the elderly group

时间窗: Between June 2021 to June 2022 and may be extended if needed

Preterm labor before 37 w of pregnancy calculated from last menstrual period.

Comparing the Neonatal outcomes of pregnancy between the young and the elderly group

时间窗: Between June 2021 to June 2022 and may be extended if needed

Include: * APGAR score system. * Neonatal intensive care unit admission

次要结局

  • Comparing the Perinatal outcomes as Birth weight between women with spontaneous pregnancy and those using Assisted Reproductive Technique(Between June 2021 to June 2022 and may be extended if needed)
  • Comparing the Obstetric outcomes as Gestational diabetes mellitus between women with spontaneous pregnancy and those using Assisted Reproductive Technique(Between June 2021 to June 2022 and may be extended if needed)
  • Comparing the Obstetric outcomes as Anemia between women with spontaneous pregnancy and those using Assisted Reproductive Technique(Between June 2021 to June 2022 and may be extended if needed)
  • Comparing the Obstetric outcomes as Oligohydramnios or polyhydramnios between women with spontaneous pregnancy and those using Assisted Reproductive Technique(Between June 2021 to June 2022 and may be extended if needed)
  • Comparing the Maternal outcomes of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive Technique(Between June 2021 to June 2022 and may be extended if needed)
  • Comparing the Fetal outcomes of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive Technique(Between June 2021 to June 2022 and may be extended if needed)
  • Comparing the Neonatal hypoglycemia of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive Technique(Between June 2021 to June 2022 and may be extended if needed)
  • Comparing the Neonatal outcomes of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive Technique(Between June 2021 to June 2022 and may be extended if needed)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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