A Phase 3 interventional study of Dexamethasone 0.5mg and Placebo in Dexamethasone and Pregnancy, sponsored by Alborz Medical University. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Alborz Medical University · Phase 3, Interventional, and Treatment
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.
Alborz Medical University is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prescribing Vaginally Dexamethasone tablets to the Group A
Drug: Dexamethasone 0.5mg
Prescribing Vaginally placebo tablets to the Group B
Drug: 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.
Also known as: Pill A
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.
Also known as: Pill B
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).
Time frame: 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).
Time frame: 6 hours after vaginally tablets installment
The Latent Phase of Labor
measured by Vaginal Examination
Time frame: from the beginning of the study to the time of 6 cm dilation of cervix
| Milestone | Dexamethasone | Placebo |
|---|---|---|
| Started | 42 | 42 |
| Completed | 41 | 42 |
| Not completed | 1 | 0 |
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).
| score on a scale | Dexamethasone | Placebo |
|---|---|---|
| First Bishop Score | 1 (1 to 2) | 1 (1 to 2) |
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).
| score on a scale | Dexamethasone | Placebo |
|---|---|---|
| Second Bishop Score | 3.5 (2 to 4) | 3 (2 to 4) |
measured by Vaginal Examination
| hour | Dexamethasone | Placebo |
|---|---|---|
| The Latent Phase of Labor | 4 (0 to 9) | 5 (0 to 8) |
Collected over 20 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Group B | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Age, Continuous(years) | Group A | Group B | Total |
|---|---|---|---|
| Median | 25 (22 to 31) | 23 (21 to 28.25) | 24 (22 to 29) |
| Sex: Female, Male(Participants) | Group A | Group B | Total |
|---|---|---|---|
| Female | 42 | 42 | 84 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Group A | Group B | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Education(Participants) | Group A | Group B | Total |
|---|---|---|---|
| Illiterate | 4 | 6 | 10 |
| Primary school | 2 | 5 | 7 |
| Junior school | 14 | 7 | 21 |
| High school | 16 | 19 | 35 |
| Associate's degree | 2 | 2 | 4 |
| Bachelor's degree or higher | 4 | 3 | 7 |
| Job(Participants) | Group A | Group B | Total |
|---|---|---|---|
| Unemployed | 37 | 40 | 77 |
| employed | 5 | 2 | 7 |
| Gravidity and parity(Participants) | Group A | Group B | Total |
|---|---|---|---|
| G1ab1 | 42 | 40 | 82 |
| G1ab2 | 0 | 1 | 1 |
| G1ab3 | 0 | 1 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Alborz Medical University