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临床试验/NCT05761769
NCT05761769招募中不适用

Twin Pregnancy: a Challenge for Patients, Families and Health Professionals

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Identify the optimal management of multiple pregnancy, identifying markers or combination of biomarkers for the early prevention of complications in multiple pregnancy in the first, second or third trimester

研究概览

简要总结

Twin pregnancies represent 3-4% of all births and in the last two decades the rate of twin pregnancies has steadily increased, essentially due to the spread of assisted fertilization techniques, the use of drugs that stimulate ovulation and increase in maternal age at conception.

Multiple pregnancies pose unique challenges for the patient, families, caregivers and society. Indeed, twin pregnancy is associated with an increased risk compared with singleton pregnancies of all feto-maternal complications of pregnancy (Level of Evidence II-2).

In twin pregnancies (both monochorionic, MC, and bichorionic, BC) the incidence of preeclampsia is about 10%, 3 times higher than in singleton pregnancies. In singleton pregnancy, the mean gestational age (GE) at delivery is 39 weeks, the mean GA at delivery in twin pregnancies is less than 36 weeks, reflecting a 9-fold higher prevalence of spontaneous preterm delivery than in singleton pregnancy. Gestational diabetes complicates about 22% of twin pregnancies compared to 7-11% of singleton pregnancies. Twin pregnancy, compared to single pregnancy, has an increased incidence of perinatal and neonatal mortality, low birth weight, chromosomal or structural defects.

A key factor to know is chorionicity. Chorionicity is a key data to acquire in the first trimester. Indeed, some complications of twin pregnancy are specific to MC pregnancy. About 20-33% of twins share the same placenta and it is precisely in these cases that a condition of greater risk is created. The most common complications of MC pregnancy are: twin-to-twin transfusion syndrome (TTTS), due to the presence of vascular anastomoses at the level of the placenta and a clear imbalance in blood flow between the twins; selective intrauterine growth restriction; the anemia-polycythemia sequence (TAPS); twin reversed arterial perfusion (TRAPS). Thus, the MC twin pregnancy is at increased risk of feto-maternal complications.

The complications of twin pregnancy place a heavy emotional and economic burden on parents, families and society.

There is no consensus in the literature on what should be the most appropriate methods for surveillance of multiple pregnancy: when to perform laboratory, instrumental and diagnostic tests for follow-up and monitoring of maternal-fetal well-being.

The aim of this project is to create a complete and accurate database that takes into consideration all aspects related to twin pregnancy. The twin pregnancy will be followed by a team of multiple pregnancy specialists who will follow the international guidelines for the surveillance of multiple pregnancy. The aim is to identify the optimal management of multiple pregnancy, collecting, studying and comparing the largest possible number of clinical, laboratory and ultrasound data from the beginning of pregnancy to the postpartum visit, developing clinical-diagnostic care pathways for follow-up and possible prevention of complications, personalized and adapted to each single woman with a twin pregnancy.

The women participating in the study will be able to enjoy close surveillance by a center specialized in the management of multiple pregnancies, this will allow for optimal management of the twin pregnancy with early identification and treatment of any complications identified.

Study typology Prospective observational longitudinal study of the overall management of patients with multiple pregnancies.

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
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Maternal age > 18 years
  • Twin pregnancy with two or more viable fetuses
  • Signature of the informed consent

排除标准

  • Women without the ability to understand the protocol
  • Women for whom the attending physician contraindicates participation in the study

结局指标

主要结局

Identify the optimal management of multiple pregnancy, identifying markers or combination of biomarkers for the early prevention of complications in multiple pregnancy in the first, second or third trimester

时间窗: through study completion, an average of 1 year

Identify the optimal management of multiple pregnancy, identifying markers or combination of biomarkers for the early prevention of complications in multiple pregnancy in the first, second or third trimester

To compare the outcomes between twin pregnancies with and without complications after introducing a specific clinical surveillance protocol that complies with the international guidelines available.

时间窗: through study completion, an average of 1 year

To compare the outcomes between twin pregnancies with and without complications after introducing a specific clinical surveillance protocol that complies with the international guidelines available.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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