IRCT138902141096N2 IRCT 2011-05-05 Vice Chancellor for research-Guilan University of Medical Sciences Efficacy of oxytocin with placebo and oxytocin with propranol on the labor augmentation. Randomized clinical trial of the efficacy of oxytocin with propranol and oxytocin with placebo on the labor augmentation. 2010-04-21 anticipated 118 Complete https://irct.ir/trial/117 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Single spontaneous delivery. Intervention 1: In Primiparous pregnant women suffering from failure to progress in the active phase of labor, 10 units of Oxytocin in one liter of Ringer lactate with 2 mg of propranolol is injected intravenously. Intervention 2: In Primiparous pregnant women suffering from failure to progress in the active phase of labor, 10 units of Oxytocin in one liter of Ringer lactate with 2 mg of distilled water as a placebo is injected intravenously.

public Dr. Seyede Hajar Sharami

Reproduction Health research center-Alzahra hospital-Namjo street

Rasht Iran (Islamic Republic of) +98 13 1322 5624 sharami@gums.ac.ir Guilan University of Medical Sciences scientific Dr. Seyede Hajar Sharami

Reproduction Health research center-Alzahra hospital-Namjo street

Rasht Iran (Islamic Republic of) +98 13 1322 5624 sharami@gums.ac.ir Guilan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria included: Primiparous pregnant women with single fetus and cephalic presentation the top 37 weeks of pregnancy (According to reliable LMP or ultrasound the first trimester) with intact membrance And fetal heart rate between 120 to 160 beats per minute and estimated fetal weight by ultrasound examination or visitors between 2500 and 4000 g and in the active phase of labor had no failure to progress. Exclusion criteria: Multi-parity, History of surgery on the uterus, malpresentation (non-cephalic), Mismatch over maternal fetal pelvis , Fetal distress, including late deceleration (Gradually reducing the minimum and maximum heart rate after completing the contract with the minimum loss rate of 15 and may take over 15 seconds) or prolong deceleration (longs over two minutes and less than 10 minutes) , Suspected macrosomia (Estimated weight over 4000 g) ,polyhydroamnius , IUGR (Estimated fetal weight using ultrasound is lower than the tenth percentile) , Women whit systolic blood pressure 90 mmHg or less And with heart rate <60 beats per minute and Women with a history of these diseases are also excluded: HTN ,Cardiac disease (Cardiac block,CHF , Right ventricular failure secondary to pulmonary hyper tension , Sinus bradycardia, Cardiogenic shock ,Significant aortic or mitral valve disease. And lung disease (Bronchial asthma or bronchospasm, severe chronic obstructive pulmonary disease, allergic rhinitis) Patients with kidney or liver dysfunction, diabetes, patients prone to hypoglycemia, myasthenia Gravis and Wolf - Parkinson – White. 15 years 45 years Female O80.0 Spontaneous vertex delivery Treatment - Drugs Placebo In Primiparous pregnant women suffering from failure to progress in the active phase of labor, 10 units of Oxytocin in one liter of Ringer lactate with 2 mg of propranolol is injected intravenously In Primiparous pregnant women suffering from failure to progress in the active phase of labor, 10 units of Oxytocin in one liter of Ringer lactate with 2 mg of distilled water as a placebo is injected intravenously The effect of oxytocin with propranolol on augmentation. Timepoint: Every hour. Method of measurement: After entering an active phase of labor the patient is examined vaginally. The effect of oxytocin without propranolol on augmentation. Timepoint: Every hour. Method of measurement: After entering an active phase of labor the patient is examined vaginally. The effect of propranolol with and without oxytocin on augmentation. Timepoint: Every hour. Method of measurement: After entering an active phase of labor the patient is examined vaginally. The frequency of cesarean section in pregnant women suffering from failure to progress in study groups. Timepoint: Active Phase of labor and then each hour. Method of measurement: vaginal examination for delitation and effacement. The frequency of Apgar scores below 7 in study groups. Timepoint: First and fifth minutes of birth. Method of measurement: Sum of all five Apgar score: heart rate, respiratory effort, muscle tone, irritability, and color. The average duration of first stage of laborinduced with oxytocin and placebo group. Timepoint: Active Phase of labor and then each hour to full dilatation. Method of measurement: Vaginal examination. The average duration of first stage of labor in study groups. Timepoint: Active Phase of labor and then each hour to full dilatation. Method of measurement: Vaginal examination. The average duration of second stage of labor in study groups. Timepoint: Every 15 minutes from full dilatation to delivery. Method of measurement: Vaginal examination. The uterine inertia in study groups. Timepoint: after delivery every 15 minutes in the first hour, every hour in 4 hours and every 4 hours in 24 hours of labor. Method of measurement: Physical examination for uterus contractions and vagina bleeding. The prevalence of meconium in study groups. Timepoint: Active phase of labor after amniotomy and then hourly. Method of measurement: Amniotomy and vaginal examination. Prevalence of placental abruption in the study group. Timepoint: Active phase of labor and then hourly. Method of measurement: checking bleeding and contractions. The prevalence of fetal distress in study groups. Timepoint: Every 15 minutes. Method of measurement: Listening to the fetal heart rate by Sonic aid. The dosage of oxytocin in study groups. Timepoint: In the active phase of labor and then every hour until reaching 3 45-60 sec contractions in 10 min. Method of measurement: Checking contractions with tochometric device. Vice Chancellor for research-Guilan University of Medical Sciences Approved 2010-03-15 Vice Chancellor for research, Guilan University of Medical Science Mellat St., Namjoo Ave Rasht Iran (Islamic Republic of)