Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2020-11-22
2021-03-21
Brief Summary
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Detailed Description
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This study was a clinical trial with the control group, blinded, randomized with a block method that was done at Kamali Hospital, Karaj, Iran.
This study was carried out between October 2019 and June 2021. At first, the researchers registered this study on the RCT(randomized controlled trial) site with the following number: IR.ABZUMS.REC1399.067.
A written consent form was obtained from all patients and the ethics committee of Alborz University of Medical Sciences confirmed the study protocol.
Study selection:
The sample size required to compare the mean of the two groups, with a 95% confidence interval and 90% test power, and considering the technical difference of 0.5 hours, was estimated to be 84 people. Then patients, randomly assigned using the block method with statistician help, were divided into two groups of 42 cases and control.
The present study was performed on 82 full-term pregnant females (38 weeks or more).they had an indication for termination of pregnancy, by accident, and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally. The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher. Group A received 14 dexamethasone tablets with a dose of 0.5 mg for vaginal use and also group B received 14 placebo tablets for vaginal use.
Patients who were Iranian, Prim gravid pregnancy with Normal Body Mass Index (BMI), Single Pregnancy presentation cephalic in Sonography, Aged 18 years old to 35 years old, Gestational age 38 weeks, Bishop score 2 and less, with Normal Non-Stress Test (NST), Estimate of Fetus Weight 2500-4000 gr and didn't take hormonal, herbal and chemical drugs and having a healthy water bag were enrolled to this Study.
Patients who had Medicine and Midwifery Complications, Lack of Desire for Cooperation, Fetal Immobility, and Maternal Bleeding were excluded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A
Prescribing Vaginally Dexamethasone tablets to the Group A
Dexamethasone 0.5mg
Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
Group B
Prescribing Vaginally placebo tablets to the Group B
Placebo
Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
Interventions
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Dexamethasone 0.5mg
Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
Placebo
Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primigravid pregnancy
* Normal of Body Mass Index
* Single Pregnancy
* presentation cephalic in sonography
* Gestational age 38 weeks
* Bishop score 2 and less
* Normal Non Stress
* Test Estimate of Fetus Weight 2500-4000 gr
* Didn't take hormonal, herbal and chemical drugs
* having a healthy water bag
Exclusion Criteria
* Lack of Desire for Cooperation
* Fetal Immobility
* Maternal Bleeding
18 Years
35 Years
FEMALE
Yes
Sponsors
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Alborz Medical University
OTHER_GOV
Responsible Party
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Matineh Nirouei
Principal Investigator
Principal Investigators
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Masoumeh Farahani, Doctor
Role: STUDY_DIRECTOR
Assistant Professor of Alborz University of Medical Sciences
Locations
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Alborz university of medical sciences
Karaj, , Iran
Countries
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References
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Farahani M, Nirouei M, Moghadam S, Hashemnejad M, Mashak B, Alinia T, Torabi S. The Effect of Using Dexamethasone Tablets Vaginally for Improving Cervical Bishop Score in Nulliparous Pregnant Women: A Randomized Clinical Trial. Curr Ther Res Clin Exp. 2023 Apr 6;98:100702. doi: 10.1016/j.curtheres.2023.100702. eCollection 2023.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IR.ABZUMS.REC.1399.067
Identifier Type: -
Identifier Source: org_study_id