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Comparison between two regimens of a particular drug Oxytocin (used for contraction of uterus) to evaluate Blood loss between them during Cesarean section.

Comparative evaluation of the effects of intravenous Oxytocin bolus(5 IU) and infusion VS. Infusion alone on the blood loss during cesarean section

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013519
Enrollment
250
Registered
2018-04-27
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- Pregnant patients posted for cesarean section

Interventions

Intervention1: oxytocin: comparison between oxytocin bolus and infusion v/s infusion alone Control Intervention1: Intravenous Oxytocin: Dose- bolus only 5 units stat, slow Intravenous over 45 seconds

Sponsors

Vardhman Mahavir Medical College and Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. pregnant patients posted for LSCS (Elective/Emergency) 2. Age >18yrs 3. Singleton term pregnancy 4. Planned spinal anesthesia 5. Fulfilling ASA I or II criteria 6. Hb>=10 gm%

Exclusion criteria

Exclusion criteria: 1. Placenta previa, PIH 2. Coagulopathies/thrombocytopenia/ on anticoagulants 3. History of previous obstetric hemorrhage 4. Grand multiparity, Fibroid uterus, hydramnios 5. Severe systemic disease 6. Failure of spinal anesthesia/conversion to GA 7. Traumatic hemorrhage during CS

Design outcomes

Primary

MeasureTime frame
1. Estimated blood loss 2. Need for additional uterotonic agents 3. Hemodynamic changes (PR, BP, HR, SpO2) 4. Side effects (headache, vomiting, chest pain) Timepoint: Time point of 48 hrs for blood loss estimation Time point for hemodynamic changes BP, PR, MAP, sPO2 per- operative every 2 min for 10 min after oxytocin bolus and every 5 min for rest of LSCS; post-operatively every 15 min for one hour, and every 30 min for next 3 hours.

Secondary

MeasureTime frame
1. Time from cord clamping to uterine hardening 2. Need for blood transfusion within 24 hrs of LSCS.Timepoint: Time point for blood transfusion is 24 hrs

Countries

India

Contacts

Public ContactDr Priyanka Mathe

V.M.M.C. and Safdarjung Hospital

drarunabatra@gmail.com9810086535

Outcome results

None listed

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