Bariatric Surgery Registration in Women of Reproductive Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Gestational weight gain
研究概览
简要总结
The use of bariatric surgery has risen subsequently over the last decade, especially in women of reproductive age. (Unplanned) pregnancies in this subgroup are not rare because of e.g. an increased fertility (because of the weight loss) and a possible ineffectiveness of contraceptives (because of a malabsorption in the intestine). Although a pregnancy after bariatric surgery is generally known as safe, there are a few studies that indicate that a pregnancy after a bariatric surgery is not always without complications, and that it should be considered as a high risk pregnancy. The research on pregnancy outcomes after this type of surgery is rather limited to a few small, mainly retrospective, observational case-control and cohort studies and a limited amount of case studies. For risk- and prognose related issues, e.g. the effect of bariatric surgery on fertility, timing of the pregnancy, development of complications during the pregnancy and pregnancy outcomes, large prospective cohort studies are needed. Besides, breast feeding practices and breast milk composition have scarcely been investigated in this population. The energy content of breast milk could possibly be influenced by a state of malabsorption after the procedure. Low amounts of vitamin B12 have also been noticed in the breast milk of women the surgery. The overall objective of this study is to establish a group of women at reproductive age (age 18-45) with a history of bariatric surgery and to generate an extensive database for future analysis. The final goal of the researchers is to develop guidelines or recommendations on how to manage pregnancies after bariatric surgery, based on large-scale prospective research.
The study design is a multicentric observational and prospective cohort study. Participants will be followed from the moment of surgery until 6 months postpartum and they can be included on several time points (before surgery, after surgery (<12 months); after surgery (>12 months) or during the pregnancy). Both retrospective and prospective data concerning the medical background, fertility (menstrual cycle), lifestyle (e.a. food, physical activities, smoking, sleeping), blood samples, psychological factors (fear and depression), sexuality, quality of life and pregnancy outcomes will be collected. Data collection by the investigators will happen in a web-based database and by direct online registration by the subjects.
详细描述
The investigators aim to develop guidelines or recommendations for the management of pregnancies after bariatric surgery based on large-scale prospective research.
The investigators want to:
- investigate pregnancy outcomes of women with a history of bariatric surgery according to procedure, interval between surgery and conception, weight change after surgery and during pregnancy and nutritional status, taking into account possible confounding factors such as economic status, alcohol and tobacco use, sleep duration, psychological factors (anxiety and depression) and quality of life
- determine the incidence of nutritional deficiencies in (pregnant) women of reproductive age after bariatric surgery.
- evaluate the effect of bariatric surgery in (morbidly) obese women of reproductive age on anthropometry, fertility, sexuality, co-morbidities, use of medication and contraceptives, pregnancy outcomes, quality of life, psychological factors (anxiety and depression), blood biochemical parameters (nutritional status), food intake and physical activity
- examine breastfeeding practices (intention, initiation, duration) and breast milk composition in women with a history of bariatric surgery
The study is a multicentric prospective cohort study with UZ Leuven as the coordinating central cite and AZ St Jan Brugge (obesity clinic and obstetric clinic), AZ St Lucas Brugge (obstetric clinic), AZ St Nikolaas St Niklaas (obesity clinic), UZ Gent (obesity clinic and obstetric clinic), AZ St Augustinus Wilrijk (obstetric clinic) and CHRH Mons Hainaut (obesity clinic and obstetric clinic) as local sites.
The design for the breast milk analyses is longitudinal and will, for practical reasons, only be initiated in UZ Leuven and UZ Gent. The investogators will collect a breast milk sample of 10 ml on day four of the postpartum and then weekly by the participants at home until the routine 6 week postpartum consultation.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Gestational weight gain
时间窗: Birth
Weight at birth minus weight at start of pregnancy
Surgical complications during pregnancy
时间窗: up to birth
bowel obstruction, strangulation, internal herniation
Gestational diabetes mellitus
时间窗: up to birth
disturbed glucose metabolism
Gestational length
时间窗: Birth
Preterm (\<37w of gestation) vs a term (37-42w of gestation) delivery
Hypertensive disorders
时间窗: up to birth
pregnancy-induced hypertension, (pre-)eclampsia
Birth weight
时间窗: Birth
Weight of newborn baby (\<2.5kg small-for-gestational age; \>4kg macrosomia)
次要结局
- Breast milk fat content(weekly from day 3-4 after delivery until week 6 after delivery)
- Vitamin B-12(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w))
- Coagulation(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w))
- Glucose(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w))
- Contraception(baseline, postoperatively (6 and 12mo))
- Dietary intake(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6 mo))
- Anxiety(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 3 (28-32w) and postpartum period (6w and 6 mo))
- Alcohol use(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6 mo))
- Smoking habits(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6 mo))
- Vitamin A(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w))
- 25-OH-vitamin D(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w))
- Quality of life assessed by the Moorehead-Ardelt Quality of Life Questinnaire II(preoperatively, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6w and 6 mo))
- Depression(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 3 (28-32w) and postpartum period (6w and 6 mo))
- Folate(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w))
- Zinc(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w))
- Breast milk protein content(weekly from day 3-4 after delivery until week 6 after delivery)
- Sexuality(baseline, postoperatively (6 and 12mo))
- vitamin K1(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w))
- Breast milk carbohydrate content(weekly from day 3-4 after delivery until week 6 after delivery)
- Physical activity(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6 mo))
- Sleeping habits(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6 mo))
- Breastfeeding practices(Postpartum period (6mo))
- Total blood count(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w))
- Mode of delivery(Birth)
- Apgar score(Birth (2-5-10 minutes))
- Anemia(baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w))
- Breast milk energy content(weekly from day 3-4 after delivery until week 6 after delivery)
- Body weight(baseline, post-operatively (3w, 3, 6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w), and 3 (28-32w) and the postpartum period (6w and 6mo))
研究者
prof. dr. Roland Devlieger
prof. dr.
Universitaire Ziekenhuizen KU Leuven