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临床试验/NCT03590483
NCT03590483已完成不适用

Maternal and Perinatal Outcomes in Spontaneous Twins Versus Twins Conceived by Ovulation Induction and Assisted Reproductive Techniques: A Cross Section Study Within One Year

Hawler Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Maternal diabetes using glucose tolerance test

研究概览

简要总结

During the last decades, assisted reproductive technique has been transformed from a miracle to real and has become widely used for treatment human infertility.

this was associated with increased the rate of twin pregnancies

详细描述

Twin pregnancies are associated with an increased risk of maternal mortality & morbidity and an increase in the incidence of neonatal morbidity and mortality compared to singleton pregnancy.

The heterogeneous results reported so far can also depend on differences in the studied populations and/or in the management approach to twin pregnancy, variability in data regarding neonatal and maternal outcomes.

Evidence on pregnancy outcomes of twins conceived by artificial reproductive technology (ART) compared with those naturally conceived (NC) is conflicting, A 2004 systematic review and a large 2008 study both were praised that in cases of twin pregnancy after assisted conception the perinatal mortality is significantly lower, when compared with those spontaneously conceived .

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • Twin delivered >24-week gestational age
  • weight ≥ 500g
  • Diachronic diamniotic twins.

排除标准

  • Intrauterine fetal deaths
  • Higher-order multiple pregnancies
  • Deliveries complicated by early vanishing fetuses
  • Twin pregnancies reduced to singleton
  • Triple pregnancy reduced to twin.

结局指标

主要结局

Maternal diabetes using glucose tolerance test

时间窗: up to 7 days postpartum

The diagnosis of GDM was based a fasting plasma glucose level of ≥5.6 mmol/L with 2 h plasma glucose level of ≥7.8 mmol/L

Admission to neonatal care unit in days

时间窗: up to 7 days

Fetal care unit

Neonatal weight in kilogram

时间窗: up to 7 days

categorized as extreme low birth weight (LBW) for \<1000 g, very LBW for 1000-1500 g, LBW for 1500-2500 g, and normal birth weight for \>2500 g

Maternal anemia using WHO criteria

时间窗: up to 1 week

Hemoglobin level less than 11gm/dl

Hypertension during pregnancy and preeclampsia diagnosed using ACOG guideline a) weight in kilogram b) Apgar score in first and 10th minutes c)Admission to neonatal intensive acre unit measured in days

时间窗: up to 1 week postpartum

Systolic and diastolic blood pressure equal or more than140/90 mm Hg measured on two or more occasions after 20 weeks of gestation in previously normotensive women, with or without proteinuria (proteinuria of \>100 mg/dL by urine analysis, or \>300 mg/24 h)

Postpartum hemorrhage

时间窗: up to 1 week

Bleeding from genital tract of 500 mL or more vaginally

Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score

时间窗: first and fifth minute of life

Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed \<0-3\>, moderately depressed\<4-6\> and excellent condition\<7-10\>

次要结局

  • Maternal mode of delivery(during labor)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shahla Alalaf

professor

Hawler Medical University

研究点 (1)

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