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Role of fibrinogen in reducing maternal blood loss during and after delivery of baby, in mothers with placenta accreta.

Evaluation of the effect of fibrinogen on peripartum hemorrhage in Placenta accreta spectrum (PAS) disorders, a double blind randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073878
Enrollment
50
Registered
2024-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: O432- Morbidly adherent placenta

Interventions

Intervention1: FIBRINOGEN: All participants in the intervention group shall receive single dose of fibrinogen 2 g i.v. in 100 ml saline (taped with opaque covering), as soon as the neonate is delivere

Sponsors

All India Institute Of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.) Age > 18 years 2.) Established diagnosis of PAS 3.) Caesarean section planned under general anaesthesia 4.) Informed written consent

Exclusion criteria

Exclusion criteria: 1.) Unwillingness to provide consent, 2.) Known case of coagulation disorders, 3.) Patient on anticoagulants

Design outcomes

Primary

MeasureTime frame
1.) Estimated blood loss intraoperatively and within 24 hours of surgery 2.) Volume of blood transfusion intraoperatively and within 24 hours of surgery.Timepoint: 1.) Estimated blood loss intraoperatively and within 24 hours of surgery 2.) Volume of blood transfusion intraoperatively and within 24 hours of surgery.

Secondary

MeasureTime frame
1.) Incidence of thromboembolic complications, if any within 7 days. 2.) Need of blood product transfusions at 24 hours and 7 days of drug administration 3.) Incidence of severe PPH, mortality. 4.) Incidence of allergic reactions 5.) ROTEM and its correlation with laboratory parameters and clinical outcomes. Timepoint: 1) 24 hours after surgery 2) Seven days after surgery

Countries

India

Contacts

Public ContactAmit Kumar Malviya

All India Institute Of Medical Sciences, New Delhi

amit2411.aiims@gmail.com9981319419

Outcome results

None listed

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