bAriatric sUrgery Registration in wOmen of Reproductive Age

NCT02515214 | Unknown

• 1 other identifier: AURORA
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bariatric Surgery Candidate; Pregnancy

Keywords

bariatric surgery; reproduction

Outcome Measures

Primary Outcomes (6)

• Gestational weight gain

  Weight at birth minus weight at start of pregnancy

  Birth

• Gestational length

  Preterm (\<37w of gestation) vs a term (37-42w of gestation) delivery

  Birth

• Surgical complications during pregnancy

  bowel obstruction, strangulation, internal herniation

  up to birth

• Gestational diabetes mellitus

  disturbed glucose metabolism

  up to birth

• Hypertensive disorders

  pregnancy-induced hypertension, (pre-)eclampsia

  up to birth

• Birth weight

  Weight of newborn baby (\<2.5kg small-for-gestational age; \>4kg macrosomia)

  Birth

Secondary Outcomes (28)

• 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)

• Breast milk fat content

  weekly from day 3-4 after delivery until week 6 after delivery

• Contraception

  baseline, postoperatively (6 and 12mo)

• Physical activity

  baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6 mo)

• Dietary intake

  baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6 mo)

Other Outcomes (7)

• Maternal age

  baseline

• Nationality

  baseline

• Family status

  baseline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

1. Women of reproductive age attending for bariatric surgery 2. Women of reproductive age with a history of bariatric surgery 3. Pregnant women with a history of bariatric surgery 4. Lactating women with a history of bariatric surgery

You may not qualify if:

• IM1
• Women
• Age between 18 and 45 years
• planning bariatric surgery
• \- Infertile (eg, hysterectomy, menopause, etc.)
• IM2
• Women
• Age between 18 and 45 years
• A bariatric surgery in the past
• \- Infertile (eg, hysterectomy, menopause, etc.)
• IM3
• Women
• Age between 18 and 45 years
• A bariatric surgery in the past
• \<15 weeks pregnant

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (2)

• Jans G, Devlieger R, De Preter V, Ameye L, Roelens K, Lannoo M, Van der Schueren B, Verhaeghe J, Matthys C. Bariatric Surgery Does Not Appear to Affect Women's Breast-Milk Composition. J Nutr. 2018 Jul 1;148(7):1096-1102. doi: 10.1093/jn/nxy085.

  PMID: 29901782 DERIVED

• Jans G, Matthys C, Bel S, Ameye L, Lannoo M, Van der Schueren B, Dillemans B, Lemmens L, Saey JP, van Nieuwenhove Y, Grandjean P, De Becker B, Logghe H, Coppens M, Roelens K, Loccufier A, Verhaeghe J, Devlieger R. AURORA: bariatric surgery registration in women of reproductive age - a multicenter prospective cohort study. BMC Pregnancy Childbirth. 2016 Jul 29;16(1):195. doi: 10.1186/s12884-016-0992-y.

  PMID: 27473473 DERIVED

Related Links

• Communication platform AURORA study

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast milk samples

Study Officials

• Roland Devlieger, MD, PhD

  KU Leuven, Dpt. Of Development and Regeneration; UZ Leuven, Dpt. of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland Devlieger, MD, PhD

CONTACT

+3216342212; roland.devlieger@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: August 4, 2015
• Study Start: July 1, 2012
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

BE (1)