To understand whether in women diagnosed with gestational diabetes well controlled on diet therapy at term (39-40 gestational weeks) would be better to induce labour or expect the spontaneous onset of labour

Gestational diabetes well controlled on medical nutritional therapy: a randomized trial of active induction of labour compared with expectant management

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/12/002290

Enrollment

220

Registered

2011-12-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Gestational Diabetes Mellitus well controlled on Medical Nutritional Therapy

Interventions

Intervention1: Induction of labour: Induction group â?? For those in the induction group arm, cervical ripening will be done with Misoprostol (25 mcg every 6th hourly for 2 doses) as is the routine fo

Eligibility

Inclusion criteria

Inclusion criteria: •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 •No contraindications to vaginal delivery

Exclusion criteria

Exclusion criteria: •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. >130, 2 hr. >140) •Women not willing for delivery at CMC, Vellore •Prior C-section •Suspected estimated fetal weight > 3.5 kg or •Any known contraindications to vaginal delivery •Uncertain gestational age •Non reassuring fetal wellbeing necessitating delivery •Maternal pregnancy-related disease necessitating delivery •Known fetal anomaly

Design outcomes

Primary

Measure	Time frame
Caesarean sectionTimepoint: At the time of delivery	—

Secondary

Measure	Time frame
Maternal â?¢Gestational age â?¢Mode of delivery â?¢Presence of perineal tears â?¢Postpartum hemorrhage Fetal â?¢The occurrence of shoulder dystocia â?¢The eventual maneuvers â?¢Newborns birth weight â?¢Apgar score â?¢Arterial cord pH 7.0 Timepoint: at time of delivery;Maternal â?¢Need for maternal blood transfusion â?¢Maternal or neonatal intensive care unit admission, duration and diagnosis â?¢Maternal and perinatal death â?¢Prevalence of DM type II at 6 weeks postpartum Neonatal â?¢Neonatal birth trauma â?¢Neonatal respiratory distress â?¢Neonatal need for respiratory support â?¢Neonatal hyperbilirubinemia â?¢Neonatal polycythemia â?¢Neonatal hypoglycemiaTimepoint: at the time of discharge	—

Measure

Time frame

Maternal â?¢Gestational age â?¢Mode of delivery â?¢Presence of perineal tears â?¢Postpartum hemorrhage Fetal â?¢The occurrence of shoulder dystocia â?¢The eventual maneuvers â?¢Newborns birth weight â?¢Apgar score â?¢Arterial cord pH 7.0 Timepoint: at time of delivery;Maternal â?¢Need for maternal blood transfusion â?¢Maternal or neonatal intensive care unit admission, duration and diagnosis â?¢Maternal and perinatal death â?¢Prevalence of DM type II at 6 weeks postpartum Neonatal â?¢Neonatal birth trauma â?¢Neonatal respiratory distress â?¢Neonatal need for respiratory support â?¢Neonatal hyperbilirubinemia â?¢Neonatal polycythemia â?¢Neonatal hypoglycemiaTimepoint: at the time of discharge

—

Countries

India

Contacts

Public ContactDr Phijam Dhaneshwor

Dept. of Obstetrics and Gynecology, CMC Hospital, Vellore

og3@cmcvellore.ac.in0416-228-3399

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026