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临床试验/CTRI/2020/10/028425
CTRI/2020/10/028425尚未招募不适用

understanding of placentation in IVF preganancy

KMC1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
KMC
入组人数
150
试验地点
1
主要终点
to study high risk pregnancy outcomes in ivf pregnancy

研究概览

简要总结

  1. Title: Understanding of placentation in IVF pregnancies

 

  1. Type of Study: Prospective observational Study

 

  1. Aims & objectives:

â—          To study complications in  IVF pregnancies

 4. Justification for study: To study relation of high risk pregnancy outcome in IVF pregnancies

 5. Departments involved: Department of Obstetrics and Gynecology

 6.  Study Period: march 2020  to April 2021

 7. Sample size: 150

 8. Materials and methods:

8a.Inclusion criteria:

â—          IVF pregnancies

8b.Exclusion criteria: nil

 8c. Biological materials:  placenta

9 .   Detailed description of procedure / processes:

Women with IVF pregnancies will be collect the history/data of antenatal period                           associated with any high risk conditions like threatened abortions in first trimister, second trimester, fetal growth restriction, Gestational Diabetis mellitus, placental abnormalities. Post delivery weight of the placenta, weight of the baby, length of the cord will be check. Post delivery look for Maternal and Fetal complications related to placental function, placenta weight with pregnancy outcomes in IVF pregnancies.

                    10.Outcome measure:

To study complications in IVF pregnancies

11.Potential risks and benefits:

Minimal potential risks as it involves only collection of history, examination and investigations reports. If you take part in this study you may help other patients with knowledge of the condition

 12.Ethical considerations and methods to address issues:

An informed consent will be obtained from the participant after discussion about the whole procedure. IEC clearance obtained and use of hospital number as indirect identifier to ensure confidentiality

 13.Budget (give details) and proposed funding source: No additional cost is required for this study.

 14.Review of literature (within 1000 words):

IVF pregnancy can result in a high risk delivery.  The purpose of this study was to understand the reasons for the high risks in IVF deliveries.  If placental and infant weights at birth are higher in IVF pregnancy, the medical intervention rate and postpartum hemorrhage might be increased.  Fetal/placental  weight ratio in Ivf pregnancies found that inappropriately heavy placentas were found in female sex and in the nulliparity group and infants from pre eclampsia mothers group. Factors like maternal age , sex of the infant can influence placental size. There are reports of placental size being linked to complications of pregnancies such as diabetes, pregnancy induced hypertension. Maternal weight gain and prepregnancy maternal BMI may have contributing influence on placental weight even in the absence of diabetes.The micro array of tissue from the placenta showed that the expression of six factors involved in regulation of angiogenesis such as basic fibroblast growth factor and vascular endothelial growth factor receptor 3 was greater in the ART group than in natural pregnancy group.In complicated pregnancies associated with low birth weight, such as pregnancies with pre eclampsia or fetal death, a relative enlargement of the placenta when compared with fetal size has been seen.  Since ART pregnancies are at increased risk of complications, disproportions between placental weight and birth weight may be more common in these pregnancies.

 15. References:

 Birthweight and placental weight; do changes in culture media used for IVF matter? Comparisons with    spontaneous pregnancies in the corresponding time periods.

Anne Essklid 1,2,3 , Lars Monkerud4 . and Tom Tanbo5,*

 Placental weight in singleton pregnancies technology: a population study of 536 567 pregnancies.

C. Haavaldsen 1,2,* , T. Tanbo 3 , and A. Esklid 1,2,4.

 Mode of conception does not affect fetal or placental growth parameters or ratios in early gestation or a delivery

Lauren W Sundheimer 1,2. jessica L Chan1. Rae Buttle1. Rosemarie Di Pentino1. Olivia Muramoto. Kerlly Castellano1. Erica T.Wang1,2.Jphn Williams III 2,3. Margareta D. Pisarska 1,2.

 Difference in the size of the placenta and umbilical cord between women with natural pregnancy and those with IVF pregnancy.

Atsushi Yanaihara1. Shota Hatakeyama1. Shirei Ohgi1. Kenichirou Motomura1. Ryoma Taniguchi1. Aguri Hirano1. Shin Takenaka1. Takumi Yanaihara1.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • all IVF pregnancy.

排除标准

  • 未提供

结局指标

主要结局

to study high risk pregnancy outcomes in ivf pregnancy

时间窗: 10 march 2020 to april 30th 2021

次要结局

  • complications in IVF pregnancies(10 march 2020 to april 30th 2021)

研究者

发起方
KMC
申办方类型
Private medical college

研究点 (1)

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