Effect of Metformin on reducing platelet dysfunction in gestational diabetes mellitus: A randomized controlled trial

Phase 4

• Conditions: grade inflammation, which trigger vascular injury and dysfunction and subsequent platelet activation.; Pregnant women with GDM typically have different levels of insulin resistance and chronic low&#45

• Registration Number: TCTR20200517003
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-17
• Study Completion: 2021-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

1. Women undergoing antenatal care and vaginal delivery at Maharaj Nakorn Chiang Mai Hospital (Faculty of Medicine, Chiang Mai University)
2. Age 20-45 years
3. The patients with gestational diabetes mellitus (GDM) diagnosed based on the National Diabetes Data Group (NDDG) criteria since 20 weeks’ gestation.
4. All women with GDM had normal medical histories before pregnancy

Exclusion Criteria

1. Patients with GDM whose blood glucose was poor controlled which need insulin therapy
2. Women with systemic diseases such as hypertension, heart disease, renal disease, connective tissue disease, hepatic disease
3. Women with twin pregnancy, major structural fetal anomaly, pregnancy-induced hypertension, and preterm labor in this pregnancy
4. Poor obstetric history requiring medication during gestation eg. recurrent pregnancy loss, previous occurrence of pre-eclampsia, preterm labor, intrauterine growth restriction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean platelet volume (MPV) In third trimester of pregnancy and intrapartum A peripheral venous blood sample, to measure complete blood count (CBC) parameters ,The blood clotting time of pregnant woman Intrapartum The whole blood clotting test,The estimate blood loss after vaginal delivery During vaginal delivery Postpartum blood loss collected via a plastic scale collecting bag

Secondary Outcome Measures

Name	Time	Method
The clotting time of cord blood During vaginal delivery The whole blood clotting test,Post-vaginal delivery complications Postpartum Post-vaginal delivery complications