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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 a statistician did coding to identify groups of users of pill A or pill B, 14 pills are used vaginally. The patients and the researcher is blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
Study design:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Prescribing Vaginally Dexamethasone tablets to the Group A |
|
| Group B | Placebo Comparator | Prescribing Vaginally placebo tablets to the Group B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 0.5mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| First Bishop Score | The total Bishop score is calculated by assessing the following five components of manual vaginal examination by a trained professional: Cervical dilation, Cervical effacement, Cervical consistency, Cervical position, and Fetal station. Dilation (score): closed(0), 1-2 cm (1), 3-4cm (2), 5>= (3) Effacement (score): 0-30% (0), 40-50% (1), 60-70% (2), 80%>= (3) Consistency (score): Firm (0), moderately firm (1), soft (2) Position (score): posterior (0), mid posterior (1), anterior(2) Station (score): -3 (0), -2 (1), -1 and 0 (2), +1 and +2 (3) The total Bishop's score which sums up all subscores can range from zero to 13, with zero meaning that the patient is not ready for induction and 13 indicating a better chance for successful induction for delivery (outcome). | at the beginning of the study |
| Second Bishop Score | The total Bishop score is calculated by assessing the following five components of manual vaginal examination by a trained professional: Cervical dilation, Cervical effacement, Cervical consistency, Cervical position, and Fetal station. Dilation (score): closed(0), 1-2 cm (1), 3-4cm (2), 5>= (3) Effacement (score): 0-30% (0), 40-50% (1), 60-70% (2), 80%>= (3) Consistency (score): Firm (0), moderately firm (1), soft (2) Position (score): posterior (0), mid posterior (1), anterior(2) Station (score): -3 (0), -2 (1), -1 and 0 (2), +1 and +2 (3) The total Bishop's score which sums up all subscores can range from zero to 13, with zero meaning that the patient is not ready for induction and 13 indicating a better chance for successful induction for delivery (outcome). | 6 hours after vaginally tablets installment |
| The Latent Phase of Labor | measured by Vaginal Examination | from the beginning of the study to the time of 6 cm dilation of cervix |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masoumeh Farahani, Doctor | Assistant Professor of Alborz University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alborz university of medical sciences | Karaj | 3149779453 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37101983 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone | 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. |
| FG001 | Placebo | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | First Bishop Score | The total Bishop score is calculated by assessing the following five components of manual vaginal examination by a trained professional: Cervical dilation, Cervical effacement, Cervical consistency, Cervical position, and Fetal station. Dilation (score): closed(0), 1-2 cm (1), 3-4cm (2), 5>= (3) Effacement (score): 0-30% (0), 40-50% (1), 60-70% (2), 80%>= (3) Consistency (score): Firm (0), moderately firm (1), soft (2) Position (score): posterior (0), mid posterior (1), anterior(2) Station (score): -3 (0), -2 (1), -1 and 0 (2), +1 and +2 (3) The total Bishop's score which sums up all subscores can range from zero to 13, with zero meaning that the patient is not ready for induction and 13 indicating a better chance for successful induction for delivery (outcome). | Posted | Median | Inter-Quartile Range | score on a scale | at the beginning of the study |
|
20 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | No deaths were recorded in the study, and no Serious Adverse Events were recorded in the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Masoumeh Farahani | Alborz University of Medical Sciences | 09123783823 | drfarahani73@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2021 | Jul 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Subjects are assigned to two groups by randomization block balanced method allocation and using quadruple blocks. In this case, there are 6 modes And in each case, 2 people will be in the control group and 2 people will be in the intervention group. Thus, by using the table of random numbers and assigning the numbers 1 to 6 to groups of 4 people, people are finally assigned to two groups of intervention and control.
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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 | Drug | 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. |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Job | Count of Participants | Participants |
|
| Gravidity and parity | Gravidity (G) is the number of times a patient has been pregnant. This includes a current pregnancy. Parity (para) is the number of times a patient has given birth to a viable child. Abortion (ab) is the term used to describe a pregnancy that ended for any given reason, including both abortions and miscarriages. | Count of Participants | Participants |
|
| OG001 | Placebo | 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. |
|
|
|
| Primary | Second Bishop Score | The total Bishop score is calculated by assessing the following five components of manual vaginal examination by a trained professional: Cervical dilation, Cervical effacement, Cervical consistency, Cervical position, and Fetal station. Dilation (score): closed(0), 1-2 cm (1), 3-4cm (2), 5>= (3) Effacement (score): 0-30% (0), 40-50% (1), 60-70% (2), 80%>= (3) Consistency (score): Firm (0), moderately firm (1), soft (2) Position (score): posterior (0), mid posterior (1), anterior(2) Station (score): -3 (0), -2 (1), -1 and 0 (2), +1 and +2 (3) The total Bishop's score which sums up all subscores can range from zero to 13, with zero meaning that the patient is not ready for induction and 13 indicating a better chance for successful induction for delivery (outcome). | Posted | Median | Inter-Quartile Range | score on a scale | 6 hours after vaginally tablets installment |
|
|
|
|
| Primary | The Latent Phase of Labor | measured by Vaginal Examination | Posted | Median | Inter-Quartile Range | hour | from the beginning of the study to the time of 6 cm dilation of cervix |
|
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Group B | No deaths were recorded in the study, and no Serious Adverse Events were recorded in the study. | 0 | 42 | 0 | 42 | 0 | 42 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Junior school |
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| High school |
|
| Associate's degree |
|
| Bachelor's degree or higher |
|
| G1ab3 |
|