Gestational diabetes well controlled on medical nutritional therapy: a randomized trial of active induction of labour compared with expectant management
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Caesarean section
Study Overview
Brief Summary
GDM is one of the most common complications of pregnancy and itsincidence is estimated at 7% (1). Among women affected by GDM, anincreased rate of C-section has been observed (2)(3). Expectant monitoring could determine an increase in macrosomic fetuses’incidence, leading to a higher C-section rate. Although induction of labourcould prevent fetal macrosomia and its consequences, its performance is thoughtto be possibly related to an enhancement in C-section and instrumental vaginaldelivery rates (4).
Strong evidence, based on adequately designedprospective studies and randomized controlled trials, in favour or against theeffectiveness and safeness of induction in women with GDM are missing (1)(5). In light of this clinical situation, randomized controlled trialcomparing induction of labour at term to careful expectant monitoring is needed
The present trial will provide evidence as to whetheror not, in women affected by gestational Diabetes on MNT, expectant managementtill 41 weeks is an effective management to ameliorate maternal and neonataloutcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •â€¢Maternal age ≥ 18 years •Willing for delivery at CMC, Vellore •Singleton pregnancy in vertex presentation •Gestational age between 39+ and 40 weeks, by LMP sure of dates or by early scan •Women diagnosed with GDM on diet therapy well controlled (AC <95, PC 1 hr.
- •<140) in the present pregnancy •No contraindications to vaginal delivery.
Exclusion Criteria
- •â€¢Pregestational diabetes •GDM diagnosed elsewhere •GDM diagnosis not based on IADPGS recommendation •GDM on OHA, Insulin or not under control(AC >95, PC 1 hr.
- •>140) •Women not willing for delivery at CMC, Vellore •Prior C-section •Suspected estimated fetal weight > 3.5 kg or < 2.5 kg at enrolment •Any known contraindications to vaginal delivery •Uncertain gestational age •Non reassuring fetal wellbeing necessitating delivery •Maternal pregnancy-related disease necessitating delivery •Known fetal anomaly.
Outcomes
Primary Outcomes
Caesarean section
Time Frame: At the time of delivery
Secondary Outcomes
- Maternal(•Need for maternal blood transfusion)