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IRCT20200610047716N1 IRCT 2020-08-18 Gorgan University of Medical Sciences Effect of rectal Progesterone on Latent Phase Prolongation in Patients with Preterm Premature Rupture of Membranes Effect of rectal Progesterone on Latent Phase Prolongation in Patients with Preterm Premature Rupture of Membranes on Neonatal and Maternal outcomes , A clinical trial study 2019-12-22 anticipated 110 Complete https://irct.ir/trial/50211 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: We use the block randomization method to randomize subjects into groups that result in equal sample sizes. We use the block size 4. From the following blocks, first select 1 by accident and divide the samples into two groups according to the order and fill the blocks A for intervention and B for placebo B A B A 2) B B A A 1) B A A B 4) A B B A 3) A A B B 6) A B A B 5). 3 PPROM. Intervention 1: Intervention group: Recipients of rectal progesterone suppository 400 mg ( Abu Reihan Company production), once a day. Intervention 2: Control group: No therapeutic intervention. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome or the like, can be shared. When: Start of access period 6 months after printing results To whom: It will be available to researchers working in academic and scientific institutions. Conditions: Use of data to complete the research process on the effects of rectal progesterone use in pregnant women with PPROM Where to obtain: Contact the author of the article responsible for the research project data. How to obtain: Contact the author of the article responsible for the research project data.Specify the type of results requested. Comments:
public Dr. Behnaz Gonabadi
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3220 2565 gonabadibehnaz@gmail.com Gorgan University of Medical Sciences scientific Dr. behnaz Gonabadi
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3220 2565 gonabadibehnaz@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Pregnant women 18-45 years Fetus age between 26-34 weeks based on first trimester of pregnancy ultrasound PPROM diagnosis based on observation of leakage during speculum examination, nitrazine positive test that these pregnant mothers PPROM without labor pain 18 years 45 years Female Fetus chromosomal abnormalities Abnormal biophysical profiles less than 4 Intrauterine growth restriction and weight less than ten percent according to the Alexander Growth Standard Maternal fever greater than 38 ° C Bleeding after week 24 Chorioamnionitis based on maternal criteria Type 1 diabetes Preeclampsia includes high blood pressure and proteinuria after 20 weeks of pregnancy Cervical discharge and severe obstetric medical diseases Taking corticosteroids or systemic steroids Receive antibiotics one week before hospital admission and antibiotic sensitivity Treatment - Drugs Other Intervention group: Recipients of rectal progesterone suppository 400 mg ( Abu Reihan Company production), once a day Control group: No therapeutic intervention Increased latent phase of labor. Timepoint: From the beginning of the latent phase to the end of the latent phase. Method of measurement: Measurement of latent phase duration based on clinical examination. Neonatal Apgar score. Timepoint: Apgar score of the first and fifth minutes after birth. Method of measurement: Based on Apgar scoring criteria. Gorgan University of Medical Sciences Approved 2020-08-16 Ethics Committee of Golestan University of Medical Sciences Golestan University of Medical Sciences, Gorgan,Shastkola road, Philosophical Higher Education Complex Gorgan Golestan Iran (Islamic Republic of)