Impact of Nutrition and Glucose levels in Obstetrics – the Frank(furt) method
Organizational Data
- DRKS-ID:
- DRKS00032967
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2023-12-29
- Last update in DRKS:
- 2024-03-11
- Registration type:
- Prospective
Acronym/abbreviation of the study
INGO
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
The aim of the study is to examine the influence of nutrition, which is characterized by nutritional variables such as stability of glucose levels and number of hyperglycemia and HbA1c, LDL, HDL, triglycerides, cholesterol, fructosamine, on the (1) time of birth and (2) progression, so time in first stage of labor and (3) to record the experience of pain. The scientific background is the influence of hyperglycemia on plasmatic prostaglandin levels. Particularly in the case of obesity with a BMI >30kg/m2, the effect of changing diet by maintaining a glucose level that is as constant as possible on the outcome of the birth must be recorded. According to the study hypothesis, a stable blood sugar level brought about by the lifestyle intervention (controlled via continuous glucose measurement in the tissue using a CGM sensor) should enable a faster, less painful birth and be associated with a lower rate of cesarean sections.
Health condition or problem studied
- Free text:
- First pregnancy in 36th week with maternal obesity
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Change in diet (constant glucose levels, avoidance of sugar and short-chain carbohydrates) from the 36th week of pregnancy in the case of maternal obesity (BMI>30kg/m2 preconception)
- Arm 2:
- Controll group: no changes in diet from the 36th week of pregnancy
Endpoints
- Primary outcome:
- time in first stage of labor
- Secondary outcome:
- - time of delivery in pregnancy - days after delivery date - Induction rate - Cesarean section rate and the indication, especially arrest in first stage of labor or unsuccessful induction - time of second stage of labor - epidural anesthesia yes/no - Rate of hyperglycemia, glucose levels and variability depending on diet - Average daily glucose level - HbA1c, LDL, HDL, triglycerides, cholesterol, fructosamine
Study Design
- Purpose:
- Other
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinikum der Johann-Wolfang-Goethe-Universität Frankfurt
Recruitment period and number of participants
- Planned study start date:
- 2024-02-15
- Actual study start date:
- 2024-02-22
- Planned study completion date:
- 2025-06-30
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 72
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Frankfurt, Abteilung für Geburtshilfe und Perinatalmedizin60596 Frankfurt am MainGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Frankfurt, Abteilung für Geburtshilfe und PerinatalmedizinDr. med. Anna HentrichTheodor-Stern-Kai 760596 Frankfurt am MainGermany
- Telephone:
- +49 69 6301 7703
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum Frankfurt am Main, Abteilung für Geburtshilfe und PerinatalmedizinProf. Dr. Dr. hc Frank LouwenTheodor-Stern-Kai 760596 Frankfurt am MainGermany
- Telephone:
- +49 69 6301 7703
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum Frankfurt am Main, Abteilung für Geburtshilfe und PerinatalmedizinProf. Dr. Dr. hc Frank LouwenTheodor-Stern-Kai 760596 Frankfurt am MainGermany
- Telephone:
- +49 69 6301 7703
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Uniklinik Frankfurt60596 FrankfurtGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission des Fachbereichs Medizin, Universitätsklinikum der Goethe-UniversitätTheodor-Stern-Kai 7, Haus 1, 2. OG, Zimmer 207-21160590 Frankfurt/MainGermany
- Telephone:
- +49-69-63013758
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de/ueber-uns/vorstand-des-universitaetsklinikums/dekan/ethikkommission
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-10-09
- Ethics committee number:
- 2023-1452
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-12-28
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry