]>
IRCT2016120711020N8 IRCT 2017-02-25 Vice chancellor for research, Zahedan University of Medical Science Effect of Nifedipin and magnesium sulfate on preterm labor Comparison of Nifedipin and magnesium sulfate effect on inhibition of preterm labor 2014-10-23 anticipated 200 Complete https://irct.ir/trial/11387 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Random allocation was performed by a methodologist using Stata V.13 in 6-piece blocks. The code of medicines were placed in similar packets and the sequence of medicines and list of random allocation of patients were not disclosed to dispensing practitioners. To conceal the random allocation process, a random 10-digit code corresponding to the identification number of the patient was written on each packet. These packets were given to the dispensing nurse, who was unaware of the contents of each packet. When the gynecologis declared the eligibility of patients, the nurse gave packets to hers according to the identification numbering. The person who assessment outcomes is unaware of the process of random allocation and type of treatment.Because of difference type of drugs administration,participants will not unaware of kind of treatments so this study is single blind. 2-3 Preterm labor. Intervention 1: Interventionl group: 10 mg oral Nifedipin is administered and if contractions continue for 15 minutes, the second dose is administered and continued every quarter of an hour for 1 hour. Then a 10 mg Nifedipin capsule per 6 hours is administered and continued to 24 hours. Intervention 2: Control group: 4 grams magnesium sulfate in 200 cc Ringer serum is infused during 20 minutes and then 2 grams magnesium sulfate is infused per hour and continued up to 24 hours or 2 hours after contraction.
public Dr. Maryam Khooshide
Arash Women Hospital, Rashid Street, Resalat Highway,Tehranpars
Tehran Iran (Islamic Republic of) +98 21 7771 9922 khooshide@tums.ac.ir Tehran University of Medical Science scientific Dr. Maryam Khooshide
Arash Women Hospital, Rashid Avenue, Resalat Highway,Tehranparse
Tehran Iran (Islamic Republic of) +98 21 7771 9922 khooshide@tums.ac.ir Tehran University of Medical Science Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Singleton pregnancy; gestational age32-34 weeks; 30 second contractions and one contraction in 10 minutes at least ; intact amniotic sack; cervical dilatation 2 cm Exclusion criteria: Underlying medical condition; severe preeclampsia; intrauterine infections; congenital anomalies 18 years 35 years Female 060.0 Preterm delivery without delivery Treatment - Drugs Treatment - Drugs Interventionl group: 10 mg oral Nifedipin is administered and if contractions continue for 15 minutes, the second dose is administered and continued every quarter of an hour for 1 hour. Then a 10 mg Nifedipin capsule per 6 hours is administered and continued to 24 hours. Control group: 4 grams magnesium sulfate in 200 cc Ringer serum is infused during 20 minutes and then 2 grams magnesium sulfate is infused per hour and continued up to 24 hours or 2 hours after contraction. Contraction. Timepoint: Every 4 hours to first 24 hours and then every 12 hours for 2 times. Method of measurement: Medical examination. Blood pressure. Timepoint: every 15 minutes up to 2 hour and every hour up to 24 hours. Method of measurement: Manometer. Shortness of breath. Timepoint: every 15 minutes up to 2 hour and every hour up to 24 hours. Method of measurement: asking the patient. Tachycardia. Timepoint: every 15 minutes up to 2 hour and every hour up to 24 hours. Method of measurement: Measuring the pulse. Vice chancellor for research, Zahedan University of Medical Science Approved 2007-01-02 Ethics committee of Zahedan University of Medical Science Khlije Fars boulevard, Zahedan Zahedan Iran (Islamic Republic of)