Investigating the role of ghrelin in fetal growth after sleeve gastrectomy
Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin
This study is trying to see how the hormone ghrelin affects the growth of babies in pregnant women who have had weight loss surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Colombes) |
| Trial ID | NCT05977790 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between maternal ghrelin levels and fetal growth in pregnant women who have undergone sleeve gastrectomy. It focuses on understanding how changes in ghrelin, an appetite-regulating hormone, may contribute to in utero growth restriction (IUGR) and birth weight outcomes. The study will include women between 3 to 6 months of pregnancy with a mono-fetal pregnancy who have previously had sleeve gastrectomy. By analyzing maternal ghrelin levels, the study seeks to identify potential factors influencing fetal growth that are not currently understood.
Who should consider this trial
Good fit: Ideal candidates are pregnant women between 3 to 6 months gestation who have previously undergone sleeve gastrectomy.
Not a fit: Patients with twin pregnancies or those who have undergone other bariatric surgery techniques may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into managing fetal growth in pregnant women who have undergone bariatric surgery.
How similar studies have performed: While there is limited research specifically linking ghrelin and pregnancy outcomes post-sleeve gastrectomy, studies on bariatric surgery and fetal growth have shown mixed results, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Woman previously operated of sleeve gastrectomy * Pregnant from 3 to 6 months * Having a mono-fetal pregnancy * Coming to consult in day hospital for a nutritional assessment Exclusion Criteria: * Twin pregnancy * Identified cause of IUGR apart from those related to sleeve gastrectomy * Woman who has undergone another bariatric surgery technique * Lack of individual information and collection of the consent form * Problems of understanding * Lack of affiliation to a social security scheme or state medical aid * Patient benefiting from a legal protection measure (with guardians or curators)
Where this trial is running
Colombes
- Hopital Louis Mourier — Colombes, France (Recruiting)
Study contacts
- Principal investigator: Séverine Ledoux, MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Séverine Ledoux, MD
- Email: severine.ledoux@aphp.fr
- Phone: 01 47 60 62 50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.