bAriatric sUrgery Registration in wOmen of Reproductive Age
Information source: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bariatric Surgery Candidate; Pregnancy
Phase: N/A
Status: Recruiting
Sponsored by: Universitaire Ziekenhuizen Leuven Official(s) and/or principal investigator(s): Roland Devlieger, MD, PhD, Principal Investigator, Affiliation: KU Leuven, Dpt. Of Development and Regeneration; UZ Leuven, Dpt. of Obstetrics and Gynecology
Overall contact: Roland Devlieger, MD, PhD, Phone: +3216342212, Email: roland.devlieger@uzleuven.be
Summary
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.
Clinical Details
Official title: Bariatric Surgery Registration in Women of Reproductive Age
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Gestational weight gainGestational length Surgical complications during pregnancy Gestational diabetes mellitus Hypertensive disorders Birth weight
Secondary outcome: Quality of lifeBreast milk fat content Contraception Physical activity Dietary intake Sleeping habits Breastfeeding practices Anxiety Depression Alcohol use Smoking habits Sexuality Total blood count Vitamin A 25-OH-vitamin D vitamin K1 Vitamin B-12 Folate Coagulation Glucose Zinc Anemia Breast milk protein content Breast milk carbohydrate content Breast milk energy content Mode of delivery Apgar score Body weight
Detailed description:
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:
1. 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
2. determine the incidence of nutritional deficiencies in (pregnant) women of reproductive
age after bariatric surgery.
3. 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
4. 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.
Women will be included in one of the following four inclusion moments (IM):
- Before surgery (women of reproductive age with morbid obesity) (IM1)
- After surgery and not being pregnant (IM2)
- Before 15 weeks of gestation (IM3)
- Day 3 of 4 of the postpartum for breast milk analyses (IM4)
A simple, user-friendly website will be used to simplify the collection and entry of data
and to create a large database. Researchers will be able to directly and continuously
register patient data (replacing paper forms) and participants will be able to complete the
questionnaires online. The database will be available via a secure online login.
Participating researchers will only have access to their own patient database.
For breast milk analyses, the investigators wil collect a sample of 10 ml during the first
feeding moment (between 8 am and 11am) on day four of the postpartum manually or by use of a
vacuum pump. Each sample is divided into two different recipients. One part of the sample is
frozen immediately in the freezer at - 20 °C. The rest of the sample will immediately be
heated to +40 °C by use of a bottle warmer. As soon as the sample is heated, it will be
ultrasonically analyzed with the MIRIS Sonicator® in order to ensure that the sample is
homogeneous. Immediately afterwards, the sample is analyzed with the Human Milk Analyzer
(HMA) (MIRIS ®, Uppsala, Sweden) for fat (g/100 ml), proteins (g/100 ml), carbohydrates
(g/100 ml), dry matter (g/100 ml) and energy (kcal/100ml). The samples that are being
collected at the participants' homes will be frozen at - 20° and afterwards analyzed with the
HMA.
There are eleven measurement points:
T0 = baseline T1 = pre-operative T2 = 3 weeks post-operative T3 = 3 months post-operative T4
= 6 months post-operative T5 = 12 of x months post-operative T6 = first trimester pregnancy
T7 = second trimester pregnancy T8 = third trimester pregnancy T9 = pregnancy T10 = 6 weeks
postpartum T11 = 6 months postpartum The number of measurements varies according to the
moment of inclusion.
1. Demographical data will be collected at (T0) (participant self-reporting). Age,
nationality, ethnicity, marital status, family status, educational level, employment
status and profession wil be questioned.
2. Anthropometric data, including body weight, waist circumference, hip circumference and
body fat percentage (if measured) are collected at all measurement points and will be
recorded by the researcher. The body length is only questioned at the first
measurement. Body height and body weight will be used to calculate the Body Mass Index
(kg/m²) at each measurement point.
3. During the first measurement the investigators will ask for past medical conditions
(reported by the researcher) and obstetric history (gravidity, parity, abortion -
self-report participant);
4. The type of procedure, date of surgery and institute of the surgeon will be recorded by
the investigators during the first measurement (Reported by researcher). Potential
problems or complications will be reported at the next measurement points. (T1-T5).
5. Current medical conditions (eg hypertension) will be reported at each measurement
point, together with the used medication (Reported by the researcher).
6. The nutritional status of the participant will be assessed by the investigators on the
basis of biochemical parameters in the venous blood. The nutritional status of the
newborn will be assessed on the basis of biochemical parameters in the venous umbilical
cord blood.
(total protein and albumin, fasten glucose level, fat soluble vitamins A, 25 - hydroxy-
vitamin D, vitamin E and vitamin K1, water soluble vitamins B1, vitamin B12 and folate
(in the serum and red blood cells (RBC), iron , (+ transferrin, transferrin saturation,
ferritin ), calcium, zinc and magnesium, hematology (hemoglobin, hematocrit and RBC
count, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration
(MCHC), mean corpuscular volume (MCV)), coagulation (prothrombin time (PT) and
activated partial thromboplastin time (aPTT)).
During measurement time T1, T3, T4, T5, a blood sample will be taken at the department
of endocrinology and on T6, T7, T9 and T10 at the department of obstetrics-gynecology.
7. Investigators will ask the participants about alcohol, tobacco and sleeping habits
(self-report participant). The alcohol consumption will be asked by using the AUDIT-C
questionnaire (Alcohol Abuse Disorder Identification Test). If the participant smokes,
the amount of cigarettes or other tobacco products that are smoked daily will be
recorded.
At the beginning of pregnancy, the participant will be asked whether alcohol and
tobacco use have changed. Finally, the sleep duration will also be determined.
8. The food intake will be measured during three days (of which at least 1 day in the
weekend), on the basis of a 3-day food diary (self-report participant). The intake of
supplements is also questioned (self-report participant).
9. Physical activity will be measured by use of the Kaiser Physical Activity Survey
(KPAS), a modified version of the Baecke physical activity questionnaire, which was
specifically designed to assess the physical activity in women. The KPAS assesses
different domains of physical activity (household /family care activities, professional
activities, activities of daily life and sports/exercise). The KPAS was validated for
both pregnant and non-pregnant women.
10. The Moorehead-Ardelt Quality of Life Questionnaire II (MA QoLQII) will be used both
pre-and postoperatively to assess the quality of life (self-report participant). This
validated questionnaire is part of the Bariatric Analysis and Reporting Outcome System
(BAROS). The MA QoLQII has been validated in an obese population and can be used for
bariatric surgery.
11. The Self-Rating Questionnaire will be used to assess the psycho-social condition of the
participant. This is a Dutch-validated questionnaire to measure anxiety, based on the
American "State-Trait Anxiety Inventory" version Y of Spielberger (35). The
questionnaire included two separated self- questionnaires in which two different
concepts can be measured: state anxiety and trait anxiety. The Edinburgh Depression
Scale (EDS), a validated 10-item questionnaire, will be used to measure depression
during pregnancy and postpartum (self-report participant).
12. A questionnaire will be used to record the menstrual cycle (self-report participant).
The menstrual cycle's length, duration of bleeding, number of periods per year, the
pattern of the menstrual cycle and the presence of amenorrhea or oligomenorrhea will be
assessed. The questionnaire is administered at T1, T4 and T5.
13. Pregnancy intention is asked in non-pregnant women (self-report participant) at the
first measurement point (T0).
14. The use of contraceptives, which also examines the therapy adherence, is also
questioned (self-report participant). The questionnaire is administered at T1, T4 and
T5.
15. Sexuality will be questioned to determine the relationship with fertility and the
interval between surgery and pregnancy (self-report participant). The questionnaire
will be completed at T1, T4 and T5.
16. Clinical pregnancy outcomes of the mother will be questioned each pregnancy trimester
(T6-T8) (Reported by the researcher) e. g. conception method, blood pressure,
gestational age, gestational diabetes, pre-eclampsia, pregnancy-induced hypertension,
clinical problems, etc. The results of the fetal ultrasounds will also be collected
during each pregnancy trimester (T6-T8). During childbirth (T9) the duration of
pregnancy, labor and delivery method will be questioned. The parameters of the newborn,
including gender, birth weight, birth length, head circumference, Apgar scores,
admission to the neonatal intensive care unit (NICU) and any complication will be
recorded (T9). Finally, postpartum data such as hemoglobin, prescribed supplements,
breastfeeding, or any other problems will be recorded.
17. A structured questionnaire about breastfeeding practices, developed by Guelinckx et al.
(2011), will be used at 6 months postpartum (T11) (self-report participant). This
questionnaire consists of 11 questions including the intention to breastfeed,
breastfeeding initiation, duration of (exclusive) breastfeeding and the reasons to stop
with breastfeeding.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Women will be included in one of the following four inclusion moments (IM):
- Before surgery (women of reproductive age with morbid obesity) (IM1)
- After surgery and not being pregnant (IM2)
- Before 15 weeks of gestation (IM3)
- Day 3 of 4 of the postpartum for breast milk analyses (IM4)
Inclusion and exclusion criteria:
1. IM1
Inclusion criteria:
- Women
- Age between 18 and 45 years
- planning bariatric surgery
Exclusion criteria:
- Infertile (eg, hysterectomy, menopause, etc.)
2. IM2
Inclusion criteria:
- Women
- Age between 18 and 45 years
- A bariatric surgery in the past
Exclusion criteria:
- Infertile (eg, hysterectomy, menopause, etc.)
3. IM3
Inclusion criteria:
- Women
- Age between 18 and 45 years
- A bariatric surgery in the past
- <15 weeks pregnant
Exclusion criteria:
- Recruitment after 15 weeks of gestation
4. IM4
Inclusion criteria:
- Women
- Age between 18 and 45 years
- A bariatric surgery in the past
- Gestational age between 37 and 42 weeks
- Giving birth of a viable child (singleton)
- Breastfeeding on day 3 of the postpartum
Exclusion criteria:
- Intake of the following drugs during lactation: psychotropic drugs, cytotoxic drugs,
beta-blockers, dopamine agonists, aspirin, antihistamines, ergotamine, lithium,
phenindione, barbiturates, anticonvulsants and sulfasalazine
- Diabetes mellitus or diabetes mellitus gravidarum
- Newborn admitted to the NICU (no rooming-in)
- Uncertainty if milk production is sufficient to meet the needs of the baby (in
consultation with the midwife)
Locations and Contacts
Roland Devlieger, MD, PhD, Phone: +3216342212, Email: roland.devlieger@uzleuven.be
UZ Leuven, Leuven 3000, Belgium; Recruiting Roland Devlieger, MD, PhD, Phone: +32 16 34 22 12, Email: roland.devlieger@uzleuven.be Roland Devlieger, MD, PhD, Principal Investigator Goele Jans, MSc, Sub-Investigator
Additional Information
Communication platform AURORA study
Starting date: July 2012
Last updated: August 3, 2015
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