To study the effects of two drugs , melatonin under the tongue and tranexamic acid in the vein for reducing blood loss during operation for delivery of baby.

Comparison of Sublingual Melatonin and Intravenous Tranexamic Acid for reducing intraoperative blood loss during Caesarean Section under Spinal Anaesthesia : A Double Blind Randomized Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071167

Enrollment

Registered

2024-07-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: O754- Other complications of obstetric surgery and procedures Health Condition 3: O754- Other complications of obstetric surgery and procedures

Interventions

Intervention1: Sublingual melatonin: 6 mg sublingual melatonin 20 minutes before spinal anaesthesia for reducing intraoperative blood loss. Control Intervention1: Intravenous tranexamic acid: 1 g intr

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients more than 18 years of age. 2.Singleton Pregnancy at a gestational age more than 37 weeks and less than 42 weeks. 3.Patients undergoing elective lower segment cesarean section under Spinal Anaesthesia 4.American society of anesthesiologists class II patients. 5.Parity 1-3

Exclusion criteria

Exclusion criteria: 1.Refusal of patient to participate in the study. 2.Patients with severe systemic diseases (liver, kidney, heart, pulmonary, hemoglobinopathies etc.) 3.Patients with bleeding disorders. 4.Patients on any anticoagulant. 5.Patients with documented drug allergy to study drugs. 6.Hb less than 9g/dl 7.Any risk factor associated with an increased risk of PPH like multiple gestation, antepartum hemorrhage, polyhydramnios, severe preeclampsia and a history of previous ruptured uterus. 8.Any placental abnormality.

Design outcomes

Primary

Measure	Time frame
To compare the volume of blood loss during elective lower segment caesarean section. Timepoint: 1.during surgery 2.hematocrit value change in first 12 hours subsequent to the lower segment cesarean section.	—

Secondary

Measure	Time frame
1.To compare the incidence of post-partum hemorrhage in both the groups. 2. To compare the amount of additional uterotonic drugs used. 3.To compare the requirement of blood transfusion. 4.To compare the requirement of surgical interventions.Timepoint: 24 hours subsequent to the lower segment caesarean section.	—

Countries

India

Contacts

Public ContactDr Neha Srivastava

Uttar Pradesh University of Medical Sciences,Saifai,Etawah,Uttar Pradesh

drurvikgmu@gmail.com7500186161

Outcome results

None listed

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