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IRCT20180227038892N1 IRCT 2020-11-10 Iran University of Medical Sciences effect of oral Dydrogesterone on the treatment of preterm labor Comparison effect of oral Dydrogesterone on the treatment of preterm labor with oral Nifedipine in pregnant women admitted with a diagnosis of risk of preterm labor 2020-10-22 anticipated 60 Complete https://irct.ir/trial/51584 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients randomly receive the first dose of 40 mg oral dydrogesterone and the second group oral standard nifedipine at the standard dose for tocolytic, and the results obtained from mothers and infants are compared in the two groups, Blinding description: All patients after hospitalization in the maternity ward are randomly divided into one of the following two groups. The first group received 40 mg of oral dydrogesterone and after 8 hours, uterine contractions were monitored again by a tocometer. if Uterine contractions do not stop , continue a dose of 10 mg every 8 hours for 48 hours. If uterine contractions do not decrease after 8 hours with this drug, patients will be treated with nifedipine. And the second group will receive oral nifedipine at a standard dose according to the protocol (starting with a dose of 10 mg every 20 minutes to an hour and continuing with 20 mg every 6 hours to 24 hours and then 20 mg every 8 hours to the next 24 hours). N/A Preterm labor. Intervention 1: Intervention group: Receive 40 mg of oral dydrogesterone and after 8 hours, uterine contractions are monitored again by a tocometer. If uterine contractions are reduced, the same drug is continued at a dose of 10 mg every 8 hours for 48 hours. If uterine contractions do not decrease after 8 hours with this drug, patients will be treated with nifedipine. Intervention 2: Control group: Oral nifedipine is administered at a standard dose according to the protocol (starting with 10 mg every 20 minutes to one hour and continuing with 20 mg every 6 hours to 24 hours and then 20 mg every 8 hours for the next 24 hours). Yes - There is a plan to make this available What will be shared: Drugs dosage, sampling method and study results are shared. When: Is given at the end of the research. To whom: People working in university centers. Conditions: For scientific promotion of university centers Where to obtain: See the email below. nedahashemi1363@yahoo.com How to obtain: First, the investigation should be completed and the applicant should send an e-mail stating all the details of his specifications, and his application will be reviewed, and if the information is approved, it will be sent to him. The time will be determined after the end of the research Comments:
public Neda hashemi
Sattar Khan St., Niayesh St., Rasoul Akram Hospital
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6650 9283 nedahashemi1363@yahoo.com Iran University of Medical Sciences scientific Neda hashemi
Sattar Khan St., Niayesh St., Rasoul Akram Hospital
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6650 9283 nedahashemi1363@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) A total of 60 women aged 18-45 years with a singleton pregnancy of 26-34 weeks, admitted with a diagnosis of preterm labor, are included in the study. 18 years 45 years Female Exclusion criteria include any maternal or fetal conditions that require immediate delivery (including fetal distress; placenta abruption; chorioamnionitis; severe preeclampsia; Patients who have entered the active phase of labor ( cervical dilatation>=4cm); vaginal bleeding; Ruptured of membrane; Uterine distention for example due to multiple pregnancy and polyhydramnios; The presence of any systemic infection; Fever greater than 38 degrees Centigrade; Intrauterine growth restriction; Blood pressure above 140/90 mm Hg; Fetal anomalies; Contraindications to the use of tocolytics, history of any allergy to progesterone and a history of any thromboembolic disease. O60 Preterm labor Prevention Prevention Intervention group: Receive 40 mg of oral dydrogesterone and after 8 hours, uterine contractions are monitored again by a tocometer. If uterine contractions are reduced, the same drug is continued at a dose of 10 mg every 8 hours for 48 hours. If uterine contractions do not decrease after 8 hours with this drug, patients will be treated with nifedipine. Control group: Oral nifedipine is administered at a standard dose according to the protocol (starting with 10 mg every 20 minutes to one hour and continuing with 20 mg every 6 hours to 24 hours and then 20 mg every 8 hours for the next 24 hours). Preterm labor. Timepoint: It is checked at the beginning of the study and then 8 hours later. Method of measurement: vaginal examination and cervical asessment. Iran University of Medical Sciences Approved 2017-01-08 School of medicine- Iran university of medical science Hemmat Highway-IRAN university of medical science Tehran Tehran Iran (Islamic Republic of)