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IRCT20171111037374N1 IRCT 2018-07-03 Fasa University of Medical Sciences Comparing the Effect of Oral Misoprostol and Intravenous Oxytocin on Labor Induction Comparing the Effect of Oral Misoprostol and Intravenous Oxytocin on Labor Induction in pregnant women 2017-12-22 anticipated 140 Complete https://irct.ir/trial/27998 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The included patients were randomly assigned to 2 study groups using a computer-based random digit generator utilizing the admission numbers, Blinding description: Participants are unaware of being present in the case and control group. Also outcome assessor and data analyser will be blind. 2-3 Condition 1: Abdominal pregnancy. Condition 2: (Induced) termination of pregnancy with other and unspecified complications. Intervention 1: Intervention group: 50 micrograms of oral misoprostol for induction of labor. If no appropriate uterine contractions were observed, patients received 50 mg Misoprostol every four hours and finally twice a day. Intravenous placebo was also received in the case group. Intervention 2: Control group: 10 units of Oxytocin dissolved in 1000 cc of dextrose 5% for labor induction. This group also received oral placebo tablets at the same time. Yes - There is a plan to make this available What will be shared: After the end of the project and the collection of information, the results are published as an article. When: The results will available 6 months after the publication To whom: The findings will be available to the public, researchers and clinicians. Conditions: All data on which non-personally identifiable data is sampled are available. Where to obtain: Applicants can receive information from the article. In addition, they can answer their questions from Corresponding Author by e-mail. How to obtain: Applicants can receive information from the article. In addition, they can answer their questions from Corresponding Author by e-mail. Comments:
public Roya Kokabi
Ebne Sina square, Fasa
Fasa Iran (Islamic Republic of) 7461686688 +98 71 5335 0994 roya.kokabi11111@gmail.com Fasa University of Medical Sciences scientific Roya Kokabi
Ebne Sina square, Fasa
fasa Iran (Islamic Republic of) 7461686688 +98 71 5335 0994 roya.kokabi11111@gmail.com Fasa University of Medical Sciences Iran (Islamic Republic of) Gestational age more than 42 weeks first and second pregnancy women over 18 years old singleton pregnancy, cervical closure (Bishop score greater than six) 18 years no limit Female Multiple pregnancies need for immediate cesarean section history of uterine scarring placenta previa vaginal bleeding more than normal postpartum bleeding heart, liver and kidney diseases history of sensitivity to Oxytocin, Misoprostol or prostaglandin analogues severe congenital anomalies in the fetus. O00.0 O04.8 Abdominal pregnancy (Induced) termination of pregnancy with other and unspecified complications Treatment - Drugs Treatment - Drugs Intervention group: 50 micrograms of oral misoprostol for induction of labor. If no appropriate uterine contractions were observed, patients received 50 mg Misoprostol every four hours and finally twice a day. Intravenous placebo was also received in the case group. Control group: 10 units of Oxytocin dissolved in 1000 cc of dextrose 5% for labor induction. This group also received oral placebo tablets at the same time. Delivery withing 48 hours after intervention. Timepoint: 48 hours after intervention. Method of measurement: Recording the number of patients with successful delivery within 48 hours. Route of delivery. Timepoint: At time if delivery. Method of measurement: Recording the route of delivery (Cesarean or vaginal delivery). Neonatal Apgar. Timepoint: 1 and 5 minutes after birth. Method of measurement: Apgar. Adverse Effects. Timepoint: 1, 2, 4, 8 and 10 days after intervention. Method of measurement: Adverse drug effects form. Fasa University of Medical Sciences Approved 2017-09-05 Ethics committee of Fasa University of Medical Sciences Ebne Sina Square Fasa Fars Iran (Islamic Republic of)