Investigation and Study of Pregnancy in Overweight or Diabetic Women and the Effect of Bariatric Surgery on Pregnancy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Birth weight (in percentiles)
研究概览
简要总结
The obesity epidemic is growing worldwide and in the UK this is perpetuated with a third of women classified as overweight/obese in 2020. Many of these woman are of childbearing age and go on to have high risk pregnancies which are often complicated by gestational or pre-existing (type 2 diabetes mellitus (GDM, T2DM). Bariatric surgery is the most successful treatment of sustainable weight loss and is associated with a reduction in rates of GDM, pre-eclampsia, delivery of large babies but increased risk of delivery of small babies and preterm delivery.
The aims of the study are to investigate the maternal and fetal/neonatal, biophysical and biochemical, intra-uterine environment and postnatal profile of pregnancies:
- affected by maternal obesity and/or GDM/T2DM compared to pregnancies with normal maternal body mass index (BMI).
- with previous maternal bariatric surgery compared to pregnancies without previous bariatric surgery but matched for maternal pre-surgery and early pregnancy BMI.
详细描述
This is an observational study. The investigators are planning to study pregnant women with normal BMI or overweight (BMI<30), obesity (BMI ≥30) and glucose disorders (GDM and T2DM). The investigators will also study pregnant women with previous bariatric surgery (gastric band, sleeve gastrectomy or gastric bypass) and compare them with pregnant women of similar pre-surgery and early pregnancy BMI, but no hisotry of weight loss surgery.
For all the participants and serially during pregnancy (at 12-14, 20-24, 26-28, 30-32, 35-37 weeks gestation and postnatally (at 6 weeks, 3 months, 12-24 months and 3-7 years of age), the investigators will perform the following investigations:
Maternal investigations: Demographics and medical history will be recorded, weight, height, waist to hip ratio and blood pressure will be measured, blood, urine, stool samples and vaginal swabs will be obtained, cervical length (by trans-vaginal ultrasound) will be measured and maternal echocardiography will be performed. Maternal glucose homeostasis will be assessed at 26-28 weeks of gestation, by a full oral glucose tolerance test, HOMA, home glucose monitoring and/ or continuous glucose monitoring (CGM), depending on the group the women belong to.
Fetal investigations: Fetal growth and well being will be assessed by 2D, 3D and Doppler ultrasound, fetal echocardiography will be performed.
At and following delivery: Maternal blood and urine samples and subcutaneous and omental fat (if Caesarean section is performed) will be obtained, placental tissue will be stored. Neonatal cord blood will be obtained, birthweight (percentiles), anthropometric characteristics will be measured, meconium and urine samples will be obtained and neonatal MRI (to assess body fat distribution) will be arranged.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Pregnant women with normal size (BMI <30)
- •Pregnant women with obesity (BMI ≥30)
- •Pregnant women with glucose disorders
- •Pregnant women with previous bariatric surgery
排除标准
- •Pregnant women less than 18 years of age
- •Pregnant women with twins/triplets
结局指标
主要结局
Birth weight (in percentiles)
时间窗: At the time of birth
Birthweight percentiles will be compared in the groups studied
次要结局
- Reported labour outcomes(At birth)
- Maternal and infant weight (in kg) and height (in cm)(Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years)
- Reported pregnancy complications(During pregnancy and up until the birth of the baby)
- Maternal and infant blood pressure (in mmHg)(Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years)
- Maternal and infant blood and urine samples(Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years)