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IRCT20181115041666N1 IRCT 2018-12-26 Mashhad University of Medical Sciences Comparison of expectant treatment outcomes in pregnant women with preterm premature rupture of membranes (PPROM) at home and hospital Investigation of maternal and neonatal outcomes of expectant treatment in pregnant women with preterm premature rupture of membranes (PPROM) in hospital compared with expectant treatment at home 2019-04-25 anticipated 100 Complete https://irct.ir/trial/35395 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. 0 (exploratory trials) preterm premature rupture of membranes. Intervention 1: Control group: Expected treatment is that in the first 72 hours of hospitalization, 2 milligrams of intravenous ampicillin in every 6 hours, 500 milligram amoxicillin capsule in every 8 hours and 400 milligram erythromycin tablet in every 6 hours are prescribed for a week. Two doses of 12 milligram Betamethasone are prescribed for intramuscular injection with a 24-hour interval in between, and accurate monitoring of the mother's vital signs, an assessment of the fetus health with daily NST and ultrasound twice a week and CBC twice a week are carried out. Intervention 2: Intervention group: After 72 hours of hospitalization and receiving the expectant treatment, mothers go home with their consent and monitor and record their daily fever and pulse rate (twice a day) and in the event of any disorder, they will immediately refer to the hospital. The executor of the plan will provide the patients under surveillance with his/her phone number and monitor their vital signs through making phone calls or sending messages in Telegram. Patients are recommend to carry out NST simultaneously with CBC twice a week. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Samaneh Akbarzadeh
Ghaem hospital, Ahmad Abad Ave
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2477 Akbarzadehs941@mums.ac.ir Mashhad University of Medical Sciences scientific Masoumeh Mirteimouri
Ommol-Banin hospital, Azadi 16th, Azadi Avenue
Mashhad Iran (Islamic Republic of) 9144663595 +98 51 3223 1444 mirteimourim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) alive singleton pregnancy Gestational age between 25 and 34 weeks The absence of chorioamnionitis symptoms The lack of evidence for fetal distress No vaginal bleeding Patient's consent Evaluation for 72 hours in hospital Cephalic presentation Having a caretaker at home Taking 60 minutes at most to reach the first treatment center The diameter of maximum vertical pocket of the amniotic fluid is more than 2 Cm² no limit no limit Female Occurrence of chorioamnionitis disturbed fetal tests of health evaluation Vaginal bleeding Patient's unwillingness to continue participation in the study Gestational age of less than 25 weeks of labor (greater than 3 cm of dilatation) O42 Premature rupture of membranes Treatment - Drugs Treatment - Drugs Control group: Expected treatment is that in the first 72 hours of hospitalization, 2 milligrams of intravenous ampicillin in every 6 hours, 500 milligram amoxicillin capsule in every 8 hours and 400 milligram erythromycin tablet in every 6 hours are prescribed for a week. Two doses of 12 milligram Betamethasone are prescribed for intramuscular injection with a 24-hour interval in between, and accurate monitoring of the mother's vital signs, an assessment of the fetus health with daily NST and ultrasound twice a week and CBC twice a week are carried out. Intervention group: After 72 hours of hospitalization and receiving the expectant treatment, mothers go home with their consent and monitor and record their daily fever and pulse rate (twice a day) and in the event of any disorder, they will immediately refer to the hospital. The executor of the plan will provide the patients under surveillance with his/her phone number and monitor their vital signs through making phone calls or sending messages in Telegram. Patients are recommend to carry out NST simultaneously with CBC twice a week. Duration of expectant treatment course. Timepoint: From hospitalization to delivery. Method of measurement: duration in days. Gestational age at the time of delivery. Timepoint: at the time of birth. Method of measurement: Course duration is measured based on the number of weeks. Birth weight. Timepoint: at the time of child birth. Method of measurement: using scales. Number of cesarean section. Timepoint: Time of birth. Method of measurement: number of cesarean section in each group. Mashhad University of Medical Sciences Approved 2018-01-03 Ethics committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)