THIRD STAGE OF LABOR MANAGEMENT MedDRA version: 14.1 Level: LLT Classification code 10029759 Term: Normal delivery System Organ Class: 100000004868
Conditions
Interventions
Trade Name: SYNTOCINON
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Oxytocin and analogues
Concentration unit: mg/g milligram(s)/gram
Concentration number: 25-
Trade Name: METHERG
Sponsors
AZIENDA OSPEDALIERA S. GERARDO DI MONZA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? To be of age (= o >18) ? Woman at 37 th to 41+5 week of pregnancy ? Single pregnancy and cephalic presentation ? Spontaneous labour Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: AT ARRIVAL IN THE DELIVERY ROOM ? Prematurity 42 week Previous CS ? Fetal growth restriction ? Macrosomia ? Multiple pregnancies ? Breech presentation ? Polihydramios ? Oligohydramnios ? Body Max Index (BMI) >35 ? 4 or more previus babies ? Antenatal risk factor ? Previous CS ? Abnormalities of the uterus ? Inducet labour ? Antepartum haemorrhage ? Maternal haematocrit level below o = 38° C ? Epidural analgesia ? SECOND STAGE ? Water birth ? Use of vacuum extraction ? Mediolateral Episiotomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): ? PPH: estimate blood loss 500 ml or grater ? Severe PPH: estimate blood loss 100 ml or greater ? After delivery (24 hours) maternal anemia: haemoglobin level below 9 g/dl;Main Objective: The primary target of this study is to proof in physiological childbirths that the conservative treatment in respect with the active treatment of the third childbirth stage does not increase post-partum haemorrhage (PPH) Secondary principle target is to proof that the conservative treatment in respect with the active one in third childbirth stage does not increase maternal anaemia.;Secondary Objective: 1. Duration of the third stage 2. Manual removal of the placenta 3. Need for therapeutic uterotonics 4. Bonding at the birth 5. Early breastfeeding 6. Increased maternal blood pressure during post-patum 7. Nausea and vomiting 8. Need for analgesic during post-partum 9. Fluid infusion after blood lost 10. Iron tablets 11. Neonatal hypothermia 12. Neonatal jaundice 13. Duration of phtotherapic treatment 14. Type of phtotherapic treatment 15. Infant haemoglobin and haematocrit 16. Woman's discharge 17. Baby's discharge 18. Admission to NICU 19. Woman's satisfaction 20. Breastfeeding at discharge and after 30 days | — |
Countries
Italy
Outcome results
None listed