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IRCT20110103005534N2 IRCT 2022-07-23 Shiraz University of Medical Sciences The effect of intravenous syntocinone injection on the third stage of labor The effect of intravenous syntocinone injection on the third stage of labor in pregnant women 2022-07-16 anticipated 100 Complete https://irct.ir/trial/64017 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be assigned to the experimental and control groups by permutation random block method.After selection samples, using random numbers table and permutation method We assign groups B and A. Permutations of A and B are AB and BA that the numbers 0 to 4 are assigned to the AB permutation and the numbers 5 to 9 are assigned to the BA permutation, Blinding description: Both the researcher and parturient will be blinded to the study. In both groups, according to the hospital routine, immediately after the birth of the baby, 20 international units of oxytocin solution is injected as an intravenous infusion. In the intervention group, the amount of 10 international units Oxytocin in the umbilical vein (near the intraitus vaginal entrance) immediately after birth the baby and the umbilical cord cut, are injected. In the control group, 1 cc of normal saline is injected in the same place. Both the researcher and parturient were blinded to the study, and the solution of syntocinon and normal saline was prepared in similar syringes by the midwife in the delivery room and given to the researchers. Also, the outcome assessor and statistical analysts will be blinded by the allocation of the study. 3 Delivery outcome. Intervention 1: Intervention group: 10 units of Oxytocin is injected into the umbilical vein (near the entrance to the vagina intraitus) immediately after the baby is born and the umbilical cord is cut in postpartum women. Intervention 2: Control group: One ml of normal saline is injected into the umbilical vein (near the entrance to the vagina intraitus) immediately after the baby is born and the umbilical cord is cut in postpartum women. Yes - There is a plan to make this available What will be shared: Primary outcome data after making participants unrecognizable will be released When: 6 months after publishing the results of primary outcome To whom: Any researchers will have access to the data after allowance of corresponding author Conditions: Performing any analysis to any data resulted form this study will be allowed only with the permission of corresponding author Where to obtain: Correspondance author How to obtain: After requesting for data, correspondence will check the authorization and then they will be informed about it Comments:
public Sara Azima
No 73,School of Nursing and Midwifery,Nemazee squair, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4258 azimas@sums.ac.ir Shiraz University of Medical Sciences scientific Sara azima
No 73,School of Nursing and Midwifery,Nemazee squair, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4258 azimas@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Term pregnancy (37-42 weeks) Single pregnancy vertex presentation Age 18- 35 years Number of deliveries 0-2 Spontaneous onset of labor pains No chronic diseases (heart disease, hypertension and diabetes) Absence of high-risk pregnancies (gestational hypertension, decreased fetal motility, fetal death, amniotic polyhydramnios and oligohydramnios known by ultrasound, rupture of membranes more than 12 hours, history of infertility) alive fetus Birth weight between 4500-2500 grams Prenatal hemoglobin more than 10 grams per deciliter absence of placenta previa absence of placenta abruption No history of any bleeding during pregnancy No curettage history Absence of any scar on the uterus Do not take anticoagulants 18 years 35 years Female Reluctance to continue participating in the study Disorders in the progress of labor prolong labor (more than 20 hours) precipitate labor( less than 3 hours) Blood pressure of 140/90 mm Hg or more during the study Disorders in labor (prolong labor, dystocia, placenta abruption , umbilical cord prolapse, etc.) Manual Removal of the Placenta Abnormal fetal heart rate patterns leading to cesarean section Lack of progress of labor that leads to cesarean section Expansion of the episiotomy Excessive postpartum hemorrhage (more than 500 cc) Using vacuum postpartum re-manipulation of the perineum Z37 Outcome of delivery Treatment - Drugs Placebo Intervention group: 10 units of Oxytocin is injected into the umbilical vein (near the entrance to the vagina intraitus) immediately after the baby is born and the umbilical cord is cut in postpartum women Control group: One ml of normal saline is injected into the umbilical vein (near the entrance to the vagina intraitus) immediately after the baby is born and the umbilical cord is cut in postpartum women Hemoglobin and hematocrit levels. Timepoint: Before intervention and 6 hours after delivery. Method of measurement: Using a microcentrifuge. Duration of the third stage of labor. Timepoint: Third stage of labor. Method of measurement: On a minute basis. Pain intensity in the third stage of labor. Timepoint: Third stage of labor. Method of measurement: Visual pain ruler. Systolic and diastolic blood pressure 30 and 60 minutes after delivery. Timepoint: 30 and 60 minutes after delivery. Method of measurement: Standard mercury blood pressure monitor. Placenta characteristics (weight - diameter - exit method - anomalies). Timepoint: After delivery of placenta. Method of measurement: observation-meter-scale. Manual Removal of the Placenta. Timepoint: After placenta delivery. Method of measurement: Observation. Shiraz University of Medical Sciences Approved 2015-05-17 Ethics committee of Shiraz University of Medical Sciences No 60 ,Zand Street, Shiraz University of Medical Sciences,Shiraz,Iran Shiraz Fars Iran (Islamic Republic of)