Enugu BRIDGES2 GDM PROJECT

Not Applicable

Not yet recruiting

• Conditions: Pregnancy and Childbirth; Diabetes mellitus

• Registration Number: PACTR201804003328818
• Lead Sponsor: International Diabetes Federation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 514

Inclusion Criteria

Pregnant women 18 years and above;
Pregnant women between 24th-28th who fulfill the diagnostic criteria of GDM:
Diagnosis of GDM will be by one-step standard 75-gram 2-hour oral glucose tolerance test using the International Association of Diabetes and Pregnancy Study Group¿s criteria.
Fasting Blood Sugar - equal or more than 5.2mmol/l to <7.0mmol/l
2-hours Post Prandial - equal or more than 8.0 mmol/l to <11.1mmol/l

Exclusion Criteria

Pregnant women younger than 18 years;
Pregnant women who fulfill diagnostic criteria for diabetes mellitus (fasting PG equal or more than 7.0 mmol/L, 2-hour PG equal or more than 11.1 mmol/L or HbA1c equal or more than 6.5% );
pre-existing/pregestational DM;
multiple pregnancy;
blood type incompatibility between mother and foetus, ABO type (pre-emptively exclude Rhesus negative mothers;
and maternal diseases: such as chronic hypertension, thyrotoxicosis, or use of long-term medicines that could alter glucose metabolism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycaemic control (SMBG <5.3mmol/L, 2hours post-prandial 7.0mmol/L and HbA1C < 6.2%);Macrosomia defined as birth weight equal or more than 4000 grams

Secondary Outcome Measures

Name	Time	Method
Incidence of Pregnancy Induced Hypertension;Registration for antenatal care ;Regular attendance for antenatal care ;Proficiency of health workers;Perinatal complications: such as presence of shoulder dystocia;Community Knowledge of DM and GDM