Effect of timing of oxytocin administration in third stage of labor
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- Primary outcome
Study Overview
Brief Summary
A total of 208 patients with defined inclusion criteria above will be randomly allocated in to two groups of 104 patients each using computer generated random number table and the allocated number will be secured in a coded opaque sealed envelope.
The patient will be allocated in one of following two groups.
Group A (N=104): patient will be given injection oxytocin 10 units IM within 15 secs of delivery followed by delayed cord clamping.8
Group B (N=104): Patient will be given injection oxytocin 10 units IM at 3 minutes of delayed cord clamping.8
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •The following women undergoing vaginal birth will be eligible for enrollment in the study: Gestation greater than 35 weeks of gestation Singleton gestation Last Hb during pregnancy more than 8.0 gm/dl.
Exclusion Criteria
- •Pregnant women with coagulopathy and bleeding disorder Pregnant women with APH (Placenta previa, placental abruption, uterine rupture and vasa previa) Fetal distress Severe FGR (fetal growth retardation.
Outcomes
Primary Outcomes
Primary outcome
Time Frame: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Maternal mean blood loss during delivery at 0
Time Frame: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Neonatal outcome
Time Frame: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Birth weight within 5 minutes
Time Frame: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Apgar score within 5 minutes
Time Frame: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Need for phototherapy after delivery
Time Frame: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Neonatal intensive care unit admission
Time Frame: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Packed cell volume in neonate at 6+2 hours of age will be done
Time Frame: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Secondary Outcomes
- Neonatal outcome(Birth weight)
Investigators
SHIKHA RANI
Government Medical college Chandigarh