DexamethasonePhase 3NCT05070468
Effect of Dexamethasone on Labor Induction
A Phase 3 study testing Dexamethasone 0.5mg in people with Dexamethasone and Pregnancy, run by Alborz Medical University at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dexamethasone, Pregnancy
- What is being tested?
- Dexamethasone 0.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteIran
- Study dates
- 22 Nov 2020to 21 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Iranian Women
- Primigravid pregnancy
- Normal of Body Mass Index
- Single Pregnancy
- presentation cephalic in sonography
- Gestational age 38 weeks
Show all 11Show fewer
- 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
Who cannot join
- Have Medicine And Midwifery Complication
- Lack of Desire for Cooperation
- Fetal Immobility
- Maternal Bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using Dexamethasone Tablets Vaginally On Improving Cervical Bishop Score in Nulliparous Pregnant Women. A Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Dexamethasone, Pregnancy
- Being tested
- Dexamethasone 0.5mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 0.5mgDrug
Also called 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.
PlaceboDrug
Also called Pill B
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Prescribing Vaginally Dexamethasone tablets to the Group A Receives: Drug: Dexamethasone 0.5mg |
| Group B | Placebo comparator | Prescribing Vaginally placebo tablets to the Group B Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 6 hours after vaginally tablets installment
The Latent Phase of Labor
measured by Vaginal Examination
Measured: from the beginning of the study to the time of 6 cm dilation of cervix
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start22 Nov 2020
- Primary completion21 Jan 2021
- Study completion21 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DexamethasoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alborz Medical University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Matineh Nirouei, Alborz Medical University
- Investigators
- Masoumeh Farahani, Doctor, Study director, Assistant Professor of Alborz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070468
- Sponsor's protocol ID
- IR.ABZUMS.REC.1399.067
- Status last verified
- Oct 2024
- First submitted
- 23 Sep 2021
- Last updated
- 12 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37101983
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Dexamethasone Tablets Vaginally On Improving Cervical Bishop Score in Nulliparous Pregnant Women. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05070468
- Acronym / sponsor ID
- IR.ABZUMS.REC.1399.067
- Conditions
- Dexamethasone, Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Alborz Medical UniversityOther government
- Study start
- 22 Nov 2020 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Mar 2021 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dexamethasone 0.5mgPrescribing Vaginally Dexamethasone tablets to the Group A |
| Group B | Placebo comparator | Drug: PlaceboPrescribing Vaginally placebo tablets to the Group B |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Iranian Women
- Primigravid pregnancy
- Normal of Body Mass Index
- Single Pregnancy
- presentation cephalic in sonography
Key exclusion criteria (4 listed)
- Have Medicine And Midwifery Complication
- Lack of Desire for Cooperation
- Fetal Immobility
- Maternal Bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 0.5mgAlso: Pill APregnant 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. | Drug | Group A |
| PlaceboAlso: Pill BPregnant 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. | Drug | Group B |
Primary outcome
First Bishop Score
Time frame: at the beginning of the study
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).
Second Bishop Score
Time frame: 6 hours after vaginally tablets installment
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).
The Latent Phase of Labor
Time frame: from the beginning of the study to the time of 6 cm dilation of cervix
measured by Vaginal Examination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37101983Farahani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masoumeh Farahani, Doctor study director
Assistant Professor of Alborz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone 0.5mg in people with Dexamethasone and Pregnancy, run by Alborz Medical University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Bishop Score (time frame: at the beginning of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05070468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.