Dexamethasone Effect on Induction of LaborPhase 4NCT03603418
Role Of Dexamethasone In Induction Of Labor
A Phase 4 study testing Dexamethasone Sodium Phosphate and Distilled water in people with Dexamethasone Effect on Induction of Labor, run by Ain Shams University at 1 site in Egypt.
Trial summary
Research hypothesis : In pregnant women undergoing induction of labor, intramuscular injection of dexamethasone may accelerate induction delivery interval. Research question : In pregnant women undergoing induction of labor, does intramuscular injection of dexamethasone accelerate induction delivery interval ? This… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dexamethasone Effect on Induction of Labor
- What is being tested?
- Dexamethasone Sodium Phosphate and Distilled water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jul 2018to Feb 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primipara.
- Gestational age (39-41) weeks according to Naegele's rule and a first-trimester ultrasound evaluation.
- Vertex presentation.
- Singleton fetus.
- Intact fetal membranes.
- No contraindication for vaginal delivery.
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- Cervix with a poor Bishop score (4-6).
- Reactive CTG.
- Average amount of liquor.
Who cannot join
- Indication for cesarean section e.g. CPD, Placenta previa, IUGR, Non vertex presentation and previous cesarean section.
- Maternal medical disorders as diabetes mellitus and severe pre-eclampsia.
- Active phase of labor (cervical dilatation of 4 cm plus 3 forceful contractions over a ten minute span).
- Preterm labor and premature rupture of membranes.
- Multiparous women.
- Significant vaginal bleeding. Placenta previa, probable placental abruption.
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- Fetal macrosomia>4.5 kg estimated by u/s.
- Multiple pregnancy.
- Fetal Distress and Non-reactive CTG.
- Oligohydramnios.
- IUGR.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 02020
Ain Shams University, 01123775756, skmabda@gmail.com
About this study
Official title: Role Of Dexamethasone In Induction Of Labor : A Randomized Clinical Trial .
Research hypothesis :
In pregnant women undergoing induction of labor, intramuscular injection of dexamethasone may accelerate induction delivery interval.
Research question :
In pregnant women undergoing induction of labor, does intramuscular injection of dexamethasone accelerate induction delivery interval ?
This study aims to assess the effect of intramuscular administration of dexamethasone on the induction delivery interval in full term patients undergoing induction of labor.
Read the detailed description
The use of corticosteroids is one of the methods put forward for the strengthening and speeding up the process of labor. After identification of glucocorticoid receptors in human amnion, the role of corticosteroids in starting the process of labor has been studied in numerous studies. Some of them discussed the relation between dexamethasone injection and labor induction but still there is insufficient data. So by the end of this study it may be possible to assess the effect of intramuscular dexamethasone injection on shortening the induction delivery interval.
- Type of Study: Randomized Clinical Double Blind Trial .
- Study Setting: The study will be conducted at Ain Shams Maternity Hospital.
- Study Population: Full term patients who attend to the labor ward in El Demerdash Maternity Hospital and scheduled for induction of labor.
- Sample Size: Sample size was calculated using PASS® version 15.0, setting the power (β) at 0.02 and the significance level (α) at 0.05. Data from previous reports (Kashanian et al., 2008) indicated that mean Induction-Active phase Interval in women receiving 8mg of dexamethasone before induction of labor and controls was 3.09±1.5 and 4.21±1.8 hours respectively. Calculation according to these values produced a minimal sample size of 70 patients to be randomized equally to both groups. Assuming a drop-out rate of 15%, a minimum drop-out inflated enrollment sample size of approximately 80 women will be needed.
- Ethical Considerations: The study will be approved from the Ethical Committee of the Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University. Informed written consent will be taken from all women before recruitment in the study, and after extensive explanation and clear discussion of risks and benefits.
- Study Procedures: A total of 80 women undergoing induction of labor will be included in this study after taking their consent for this clinical trial after full explanation of the trial.
- Being tested
- Dexamethasone Sodium Phosphate, Distilled water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Sodium PhosphateDrug
Dexamethasone is a synthetic glucocorticoid that is commonly used in human medical practice as potent anti-inflammatory, immunosuppressive and analgesic agent.
Distilled waterOther
Distilled water
| Study group | Role | What they receive |
|---|---|---|
| Group D (Study group-Dexamethasone group) | Experimental | Forty patients undergoing induction of labor will receive 8 mg (2ml) of the product dexamethasone sodium phosphate intramuscular one hour before the initiation of labor induction in the form of epidrone ampoules which is a dexamethasone product from Epico-Egypt, and labor induction will be performed according to the American College of Obstetricians and Gynecologists protocol, i.e, starting by 25 mcg of PGE1 vaginally, in the form of Vagiprost, every 3-6 hours according to patient response, Dexamethasone will be given one hour before the first dose of Vagiprost, when bishop score reaches 6 to 8, oxytocin will be added by 5 drops/minute of 500 cc saline + 5 units of oxytocin with the dose increasing by 5-10 drops / minute every 30 minute till optimal contractions are reached which are three uterine contractions in 10 minutes and each lasting for 40-50 seconds Receives: Drug: Dexamethasone Sodium Phosphate |
| Group C (Control group) | Placebo comparator | Forty patients undergoing induction of labor will receive 2ml of distilled water intramuscular one hour before the initiation of labor induction, and labor induction will be performed by the same protocol as above. Receives: Other: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction delivery interval
The time between beginning of the induction of labor till the end of the 2nd stage of labor
Measured: It may vary from 4 to 6 hours up to 72 hours
Secondary outcomes (1)
Induction active phase interval
The time between beginning of the induction of labor till the beginning of the 1st stage of labor
Measured: It may vary from 2 to 3 hours up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start13 Jul 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dexamethasone Effect on Induction of LaborStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Medhat Mohamed Abdallah, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603418
- Sponsor's protocol ID
- 292017
- Status last verified
- Jan 2019
- First submitted
- 8 Jul 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Dexamethasone In Induction Of Labor : A Randomized Clinical Trial .
- ClinicalTrials.gov ID
- NCT03603418
- Acronym / sponsor ID
- 292017
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research hypothesis :
In pregnant women undergoing induction of labor, intramuscular injection of dexamethasone may accelerate induction delivery interval.
Research question :
In pregnant women undergoing induction of labor, does intramuscular injection of dexamethasone accelerate induction delivery interval ?
This study aims to assess the effect of intramuscular administration of dexamethasone on the induction delivery interval in full term patients undergoing induction of labor.
Detailed description
The use of corticosteroids is one of the methods put forward for the strengthening and speeding up the process of labor. After identification of glucocorticoid receptors in human amnion, the role of corticosteroids in starting the process of labor has been studied in numerous studies. Some of them discussed the relation between dexamethasone injection and labor induction but still there is insufficient data. So by the end of this study it may be possible to assess the effect of intramuscular dexamethasone injection on shortening the induction delivery interval.
- Type of Study: Randomized Clinical Double Blind Trial .
- Study Setting: The study will be conducted at Ain Shams Maternity Hospital.
- Study Population: Full term patients who attend to the labor ward in El Demerdash Maternity Hospital and scheduled for induction of labor.
- Sample Size: Sample size was calculated using PASS® version 15.0, setting the power (β) at 0.02 and the significance level (α) at 0.05. Data from previous reports (Kashanian et al., 2008) indicated that mean Induction-Active phase Interval in women receiving 8mg of dexamethasone before induction of labor and controls was 3.09±1.5 and 4.21±1.8 hours respectively. Calculation according to these values produced a minimal sample size of 70 patients to be randomized equally to both groups. Assuming a drop-out rate of 15%, a minimum drop-out inflated enrollment sample size of approximately 80 women will be needed.
- Ethical Considerations: The study will be approved from the Ethical Committee of the Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University. Informed written consent will be taken from all women before recruitment in the study, and after extensive explanation and clear discussion of risks and benefits.
- Study Procedures: A total of 80 women undergoing induction of labor will be included in this study after taking their consent for this clinical trial after full explanation of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D (Study group-Dexamethasone group) | Experimental | Drug: Dexamethasone Sodium PhosphateForty patients undergoing induction of labor will receive 8 mg (2ml) of the product dexamethasone sodium phosphate intramuscular one hour before the initiation of labor induction in the form of epidrone ampoules which is a dexamethasone product from Epico-Egypt, and labor induction will be performed according to the American College of Obstetricians and Gynecologists protocol, i.e, starting by 25 mcg of PGE1 vaginally, in the form of Vagiprost, every 3-6 hours according to patient response, Dexamethasone will be given one hour before the first dose of Vagiprost, when bishop score reaches 6 to 8, oxytocin will be added by 5 drops/minute of 500 cc saline + 5 units of oxytocin with the dose increasing by 5-10 drops / minute every 30 minute till optimal contractions are reached which are three uterine contractions in 10 minutes and each lasting for 40-50 seconds |
| Group C (Control group) | Placebo comparator | Other: Distilled waterForty patients undergoing induction of labor will receive 2ml of distilled water intramuscular one hour before the initiation of labor induction, and labor induction will be performed by the same protocol as above. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Primipara.
- Gestational age (39-41) weeks according to Naegele's rule and a first-trimester ultrasound evaluation.
- Vertex presentation.
- Singleton fetus.
- Intact fetal membranes.
Key exclusion criteria (11 listed)
- Indication for cesarean section e.g. CPD, Placenta previa, IUGR, Non vertex presentation and previous cesarean section.
- Maternal medical disorders as diabetes mellitus and severe pre-eclampsia.
- Active phase of labor (cervical dilatation of 4 cm plus 3 forceful contractions over a ten minute span).
- Preterm labor and premature rupture of membranes.
- Multiparous women.
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 Sodium PhosphateDexamethasone is a synthetic glucocorticoid that is commonly used in human medical practice as potent anti-inflammatory, immunosuppressive and analgesic agent. | Drug | Group D (Study group-Dexamethasone group) |
| Distilled waterDistilled water | Other | Group C (Control group) |
Primary outcome
Induction delivery interval
Time frame: It may vary from 4 to 6 hours up to 72 hours
The time between beginning of the induction of labor till the end of the 2nd stage of labor
1 secondary outcome
Induction active phase interval
Time frame: It may vary from 2 to 3 hours up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone Sodium Phosphate and Distilled water in people with Dexamethasone Effect on Induction of Labor, run by Ain Shams University at 1 site in Egypt.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Jan 2019. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction delivery interval (time frame: It may vary from 4 to 6 hours up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2019.