Health Condition 1: O429- Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor
Conditions
Interventions
Intervention1: Intra amniotic injection of fibrin and platelets.: Intra amniotic injection of fibrin and platelets under ultrasound guidance.
Control Intervention1: Amniopatch: Intra amniotic injectio
Sponsors
Santasa Fertility Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Previable PV- PROM with leak before 28 completed weeks of gestation. 2. Confirmed leak by visual inspection on per speculum / Vaginal pH more than 7 3. A minimum cervical length of 1cm or more 4. With or without Cervical encirclage 5. Sufficient amniotic fluid with AFI of 2cm or more 6. Willingness to undergo IFPRP therapy. 7. Availability for follow-up assessments.
Exclusion criteria
Exclusion criteria: i. Doubtful PROM ii. Cases where Intraamniotic Injection will be difficult with anterior placenta / very less or no liquor. iii. Cases with co morbidities, fever, PIH, scenarios where there is threat to the life of mother like Choriamnionitis, Severe infection, Diabetes, Cardiac or Renal issues etc. iv. Patients in active labour /acting uterus v. Gestational age beyond 28 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stopping of leakageTimepoint: Baseline and 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| i) Time to delivery ii) Maternal Outcome iii) Foetal / neonatal outcomes iv) Whether there was any reduction in termination of pregnancy - Comparison of rates of termination in the study population with historical data.Timepoint: 1 week, 28 weeks, 37 weeks and at time of delivery. | — |
Countries
India
Contacts
Public ContactSowmya Hosa Agrara Rajashekar
Santasa Fertility Pvt Ltd
Outcome results
None listed