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IRCT20190623043981N1 IRCT 2020-05-04 Kerman University of Medical Sciences Comparison of oral and intramuscular progesterone in preterm labor Comparison of pregnancy outcome following oral and intramuscular progesterone use in preterm labor 2019-02-23 anticipated 146 Complete https://irct.ir/trial/40346 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After stopping labor pain successfully, 146 patients in the form of randomization allocation are divided into to two groups (A= 73 and B= 73) according to random number table. This study was performed as a single-blind study. The patient and physician were aware of the type of treatment and only the person evaluating the data was unaware of the type of treatment at the end. The statistical consultant performed randomization and provided the results to the researcher and the researcher assigned the participants to the interventions groups, Blinding description: during this study, the data evaluator was unaware of the treatment types, while physician and patient blinding was impossible as the difference of the used methods was obvious to the them. 2-3 Preterm labour. Intervention 1: In the intervention group one, until 36 weeks of pregnancy, 200 mg capsule containing micronized progesterone called luteogel produced by Tasnim company will be given daily . Intervention 2: Intervention group two a 250 mg progesterone ampoule containing hydroxy caproate produced of Byer company will be given weekly and treatment will continue until 36 weeks of pregnancy. Yes - There is a plan to make this available What will be shared: Total data When: Starting six months after the publication of the article To whom: Researchers, students and doctors Conditions: To perform clinical examination Where to obtain: General or scientific responsible person How to obtain: Submit the proposal to the responsible person Comments:
public Moeeneh Barkhori Mehni
Unit 8 Shyda Building Khajo 34 Street
Kerman Iran (Islamic Republic of) 7617778555 +98 34 3252 1679 moeeneh1367@gmail.com Kerman University of Medical Sciences scientific Moeeneh Barkhori Mehni
Afzalipour Hospital Emam Highway
Kerman Iran (Islamic Republic of) 7616914115 +98 34 3132 8307 moeeneh1367@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Single-tone pregnancy alive fetus intact membrane gestational age between 24-36 weeks preterm labor lack of cerclage labor pains in the form of contractions alternating 2 times in 10 minutes or 8 times in 60 minutes cervical dilatation equal to or greater than 1 cm ultrasound of the first 3 months of pregnancy no limit no limit Female vaginal bleeding known uterine anomalies fetal anomalies suspicion of intrauterine infection preterm premature rupture of membranes (PPROM) cervical dilation greater than 3 cm fetal death or fetal distress maternal systemic diseases history of taking any medication other than the usual supplements during pregnancy polyhydramnios and oligohydramnios being dangerous for the mother to continue the pregnancy due to medical reasons lack of cooperation of mothers during study O60.0 Preterm labour without delivery Treatment - Drugs Treatment - Drugs In the intervention group one, until 36 weeks of pregnancy, 200 mg capsule containing micronized progesterone called luteogel produced by Tasnim company will be given daily . Intervention group two a 250 mg progesterone ampoule containing hydroxy caproate produced of Byer company will be given weekly and treatment will continue until 36 weeks of pregnancy. Birth weight. Timepoint: after delivery. Method of measurement: Scale. Gestational age at delivery. Timepoint: after delivery. Method of measurement: patient documents. Latency period. Timepoint: from beginning of intervention until delivery. Method of measurement: patient documents. Number of hospitalized neonates in each group. Timepoint: after delivery. Method of measurement: patient documents. Kerman University of Medical Sciences Approved 2019-02-22 ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)