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IRCT20250118064418N1 IRCT 2025-03-01 Zahedan University of Medical Sciences Efficacy of vaginal Dexamethasone in cervical preparation Comparison of the effectiveness of vaginal dexamethasone and placebo in preparing the cervix for induction of labor in primiparous pregnant women 2025-02-08 anticipated 100 Complete https://irct.ir/trial/81444 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 1. Randomization method and description of each method Type of randomization: Block randomization with blocks of four was used in this study 2. Randomization unit Individual randomization: Subjects are entered into the study individually based on patient referrals and are assigned to intervention and control groups through block randomization. 3. Stratified randomization layers If it is necessary to control the effect of intervening variables (such as age, sex, and underlying diseases), stratified randomization is used to perform randomization in each layer in such a way that the balance between groups is maintained regarding important variables. 4. Randomization tool and method of constructing random sequences: It will be using SPSS software. Number of samples: Finally, 50 subjects were placed in the intervention group and 50 subjects in the control group to maintain balance in the sample size, Blinding description: After enrollment, patients, investigators, and research staff are blinded. Dexamethasone and placebo tablets of the same shape and size, labeled Tablet A and Tablet B, are dispensed by a non-interventionist in the study. Research staff are blinded to the allocation of study drug tablets. 2-3 Induction of labor with dexamethasone. Intervention 1: Intervention group: Dexamethasone tablets labeled as Tablet A are delivered by a non-interventionist in the study. Dexamethasone is administered in the amount of 8 mg in the form of 2 Dexamethasone tablets (4 mg, from a single company (Obeidi Company) and specified) every 6 hours and vaginally in group A. According to the study protocol, an obstetrician and gynecologist will prescribe the tablets. Vaginal tablets are given to primiparous patients from the onset of labor pains and it is recommended to use 2 tablets every 6 hours and vaginally. If possible, do not move for at least 2 hours after using the tablet. Also, to ensure the use of the tablet, a daily registration form is given to the participants to record each time the tablet is used. Intervention 2: Control group: Placebo labeled as pill B is delivered by a non-interventionist in the study. It is used as 2 pills (completely identical to the intervention drug) every 6 hours and vaginally. According to the study protocol, an obstetrician-gynecologist will prescribe the pill. Vaginal pills are given to primiparous patients from the onset of labor pains and it is recommended to use 2 pills every 6 hours and vaginally. If possible, do not move for at least 2 hours after using the pill. Also, to ensure the use of the pill, participants are given a daily registration form to record each time the pill is used. Yes - There is a plan to make this available What will be shared: Information about the main outcome When: Access period starts 6 months after results are published. To whom: Researchers working in academic and scientific institutions Conditions: The use of data for research purposes will be permitted. A written request from the requesting person and a guarantee of confidentiality of the information are required. Where to obtain: Email: setareh jami setarehjami9111@gmail.com How to obtain: Submitting a request - Reviewing the request and complying with scientific and ethical principles - Validating the requester - Responding Comments:
public Setareh Jami
Khalij -e- Fars Blvd
Zahedan Iran (Islamic Republic of) 9816743175 +98 915 763 6126 setarehjami9111@gmail.com Zahedan University of Medical Sciences scientific Setareh Jami
Khalij -e- Fars Blvd
Zahedan Iran (Islamic Republic of) 9816743175 +98 915 763 6126 setarehjami9111@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Primiparous pregnant mother singleton pregnancy full pregnancy (37 weeks and 6 days and more) age between 18 and 35 years normal body mass index 18.5 to 24.9 the fetus must be in cephalic position Bishop's score ≤4 estimated fetal weight of 2500-4000 grams the gynecologist and obstetrician make the patient a candidate for termination of pregnancy 18 years 35 years Female If the pregnant woman use any hormones or herbal medicines (traditional medicines), herbal/natural products, or conventional/prescribed medicines during her pregnancy Those with the following pre-existing conditions, including diabetes, high blood pressure, a history of obstetric complications such as preeclampsia or eclampsia, or HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets) Those with a previous presentation with fetal inactivity/decreased fetal movements Those with a previous presentation with a history of maternal hemorrhage Treatment - Other Treatment - Other Intervention group: Dexamethasone tablets labeled as Tablet A are delivered by a non-interventionist in the study. Dexamethasone is administered in the amount of 8 mg in the form of 2 Dexamethasone tablets (4 mg, from a single company (Obeidi Company) and specified) every 6 hours and vaginally in group A. According to the study protocol, an obstetrician and gynecologist will prescribe the tablets. Vaginal tablets are given to primiparous patients from the onset of labor pains and it is recommended to use 2 tablets every 6 hours and vaginally. If possible, do not move for at least 2 hours after using the tablet. Also, to ensure the use of the tablet, a daily registration form is given to the participants to record each time the tablet is used. Control group: Placebo labeled as pill B is delivered by a non-interventionist in the study. It is used as 2 pills (completely identical to the intervention drug) every 6 hours and vaginally. According to the study protocol, an obstetrician-gynecologist will prescribe the pill. Vaginal pills are given to primiparous patients from the onset of labor pains and it is recommended to use 2 pills every 6 hours and vaginally. If possible, do not move for at least 2 hours after using the pill. Also, to ensure the use of the pill, participants are given a daily registration form to record each time the pill is used. Cervical preparation rate for labor induction in primiparous pregnant mothers. Timepoint: During labor, the first minute, and the fifth minute after delivery. Method of measurement: Cervical preparation dosage form for labor induction. Newborn Apgar score. Timepoint: The first and fifth minutes after birth. Method of measurement: The Apgar score, also known as APGAR, is an acronym for 5 criteria that are each examined separately: Skin color (Appearance), Pulse or heart rate (Pulse), Reflex reactions (Grimace), Muscle tone or consistency (Activity), and Respiration. Bishop Score. Timepoint: The initial visit of the pregnant woman and entry into the study and during delivery. Method of measurement: Based on 5 components of dilation, effacement, consistency, cervical position, and organ position, demonstrated through pelvic examination, each of which is given a score from 0 to 3. Zahedan University of Medical Sciences Approved 2024-10-16 Ethics committee of Zahedan University of Medical Sciences Khalij -e- Fars Blvd Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)