Impact of Nutrition and Glucose levels in Obstetrics – the Frank(furt) method

Not Applicable

Recruiting

• Conditions: First pregnancy in 36th week with maternal obesity

• Registration Number: DRKS00032967
• Lead Sponsor: niversitätsklinikum Frankfurt, Abteilung für Geburtshilfe und Perinatalmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

Primiparous patient
- Singleton pregnancy
- The pregnant woman owns a smartphone that is compatible with the app libre 3 (see manufacturer list)
- BMI>30 kg/m² preconception or
- fetal sonographic abnormalities in the sense of a diabetogenic metabolic state (polyhydramnios, head-abdomen discrepancy, macrosomia), without an abnormal glucose tolerance test or
- previously known PCOS or known insulin resistance without an abnormal glucose tolerance test

Exclusion Criteria

- multiparous patients,
- Contraindications for vaginal birth (placenta previa, fetal diseases)
- Maternal diseases: preeclampsia/HELLP syndrome, uterine anomalies
- Taking medication: cortisone, acetylsalicylic acid, L-dopa
- diabetes mellitus type 1/2/gestational diabetes
- abnormal glucose tolerance test
- lack of consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
time in first stage of labor

Secondary Outcome Measures

Name	Time	Method
- time of delivery in pregnancy<br>- days after delivery date<br>- Induction rate<br>- Cesarean section rate and the indication, especially arrest in first stage of labor or unsuccessful induction<br>- time of second stage of labor <br>- epidural anesthesia yes/no<br>- Rate of hyperglycemia, glucose levels and variability depending on diet<br>- Average daily glucose level <br>- HbA1c, LDL, HDL, triglycerides, cholesterol, fructosamine