Labor InductionEarly Phase 1NCT07109258
Effect of Dexamethasone on Labour Induction in Term Pregnancies
A Early Phase 1 study testing Dexamethasone (Decadron) 8mg IM injection, Misoprostol 25 mcg and Both Misoprostol 25 mcg & Dexamethasone 8mg IM injection in people with Labor Induction, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to assess the effect of dexamethasone on labour induction in term pregnancies. Primary outcome: The interval between initiation of induction and beginning of the active phase of labour. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Induction
- What is being tested?
- Dexamethasone (Decadron) 8mg IM injection, Misoprostol 25 mcg and Both Misoprostol 25 mcg & Dexamethasone 8mg IM injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 15 Sep 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Nulliparous.
- Vertex presentation.
- Singleton pregnancy.
- Gestational age ≥ 39 weeks according to a reliable date for the last menstrual period or a first-trimester ultrasound evaluation.
- No contraindication for vaginal delivery.
Who cannot join
- Indication for cesarean section e. g. Placenta previa, intrauterine growth retardation, non-vertex presentation and previous cesarean section.
- Maternal medical disorders as diabetes mellitus and severe pre-eclampsia.
- Preterm labour and preterm rupture of membranes.
- Gestational age <39 weeks of gestation.
- Fetal macrosomia > 4kg (estimated by u/s).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospital (Kasr Al Ainy)
Cairo, Manial, 11562
Abdelfatah M Eldesouky, MD, MRCOG, 00201003370784, a.f.dessouki@gmail.com
About this study
The aim of the study is to assess the effect of dexamethasone on labour induction in term pregnancies.
Primary outcome:
Read more
The interval between initiation of induction and beginning of the active phase of labour.
Secondary outcomes:
- Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation).
- Duration of second stage of labour
- Mode of delivery.
- Fetal outcome.
Group A:
Will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL).
Group B:
Will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h.
Group C:
Will receive one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h.
Read the detailed description
- Study type: Randomized Controlled Trial
- Population of study:
Pregnant women above 18 years of age, eligible for induction of labour.
● Study location: Cairo University Obstetrics \& Gynecology Hospital (Kasr Al-Ainy)
- Methodology in details:
- Every subject will be subjected to:
- Written consent.
- Complete history to exclude systemic disorders, congenital fetal malformation and contraindications for vaginal delivery.
- General examination of the patients including pulse, blood pressure and body mass index, [weight (kg)/ height (m2)] (20-25) normal weight, (25-30) overweight, (30-35) obese, (35-40) very obese and >40 morbid obese.
- Abdominal examination including presentation, station of fetal head, fetal heart rate, uterine contractions and exclusion of multiple pregnancies.
- Local examination to determine cervical dilatation at the beginning of intervention, presenting part, station of fetal head, pelvic adequacy and Bishop scoring.
- Sonographic examination including assessment of fetal well-being by biophysical profile.
- Patients will be randomly assigned to three groups using simple randomization via computer-generated random numbers will be used.
- The women will be divided into three groups:
- Group A: They will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL).
- Group B: They will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h.
- Group C: They will receive one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h.
- Regarding group A,B and C the investigators will wait 24hrs after the last dose, then reassessment by senior obstetrician will be done and if induction is unsuccessful it'll be determined whether the patient is for either CS or second 24hr attempt at induction by misoprostol.
- Primary outcome:
The interval between initiation of induction and beginning of the active phase of labour.
- Secondary outcomes:
- Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation).
- Duration of second stage of labour
- Mode of delivery.
- Fetal outcome.
- Sample size Assuming that the mean interval between the start of induction and the beginning of the active phase among cases 2.87±1.57 hours versus 3.8±1.72 hours among controls, so a minimum sample of 150 patients, divided into three equal groups (50 patients each), will achieve 80% power at 0.05 significance level. Sample size calculated using OpenEpi, Version 3, open source calculator-(SSMean).
- Conditions
- Labor Induction
- Being tested
- Dexamethasone (Decadron) 8mg IM injection, Misoprostol 25 mcg, Both Misoprostol 25 mcg & Dexamethasone 8mg IM injection
- Keywords
- Labor Induction, Dexamethasone, Misoprostol, Term pregnancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (Decadron) 8mg IM injectionDrug
one dose of IM dexamethasone sodium phosphate 8 mg (2 mL) given at the start of labour induction
Misoprostol 25 mcgDrug
vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h.
Both Misoprostol 25 mcg & Dexamethasone 8mg IM injectionDrug
one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | They will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL). Receives: Drug: Dexamethasone (Decadron) 8mg IM injection |
| Group B | Active comparator | They will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h. Receives: Drug: Misoprostol 25 mcg |
| Group C | Experimental | They will receive one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h. Receives: Drug: Both Misoprostol 25 mcg & Dexamethasone 8mg IM injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The interval between initiation of induction and beginning of the active phase of labour.
Assessed hourly
Measured: The interval between initiation of induction and beginning of the active phase of labour, assessed hourly up to 24 hours.
Secondary outcomes (5)
Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation).
Assessed hourly
Measured: Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation), assessed hourly up to 24 hours.
Duration of second stage of labour
Measured: Recorded immediately with delivery of the baby
Mode of delivery
Vaginal or Cesarean
Measured: After induction attempt (24 hours)
Fetal outcome
APGAR score
Measured: At 1 and 5 minutes after delivery
Fetal Outcome
NICU admission
Measured: Recorded within 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 May 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Labor InductionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Group A: They will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL). 2. Group B: They will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h. 3. Group C: They will receive one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h. * Regarding group A,B and C we will wait 24hrs after the last dose, then reassessment by senior obstetrician will be done and if induction is unsuccessful it'll be determined whether the patient is for either CS or second 24hr attempt at induction by misoprostol.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelfatah Mohamed Kamel Eldesouky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109258
- Sponsor's protocol ID
- MS-552-2024
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Confidentiality
Publications
Vilas-Boas LS, Sanches MPR, Araujo Junior E, Peixoto AB, Mattar R, Santos LRRD, Pares DBDS, Sun SY. Evaluation of the efficacy of labor induction with vaginal misoprostol in a low-risk pregnant women population. Rev Assoc Med Bras (1992). 2024 Jul 19;70(7):e20240132. doi: 10.1590/1806-9282.20240132. eCollection 2024.
PubMed 39045936Laloha F, Asiabar NM, Barikani A, Movahed F, Haj Seyed Javadi E. Effect of Intravenous Dexamethasone on Preparing the Cervix and Labor Induction. Acta Med Iran. 2015;53(9):568-72.
PubMed 26553085Mohaghegh Z, Faal Siahkal S, Bahmaei H, Sharifipour F, Leyli EK, Zahedian M. The effect of dexamethasone on labor induction: a systematic review. BMC Pregnancy Childbirth. 2021 Aug 17;21(1):563. doi: 10.1186/s12884-021-04010-1.
PubMed 34404372Kavanagh J, Kelly AJ, Thomas J. Corticosteroids for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD003100. doi: 10.1002/14651858.CD003100.pub2.
PubMed 16625570
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone on Labour Induction in Term Pregnancies
- ClinicalTrials.gov ID
- NCT07109258
- Acronym / sponsor ID
- MS-552-2024
- Conditions
- Labor Induction
- Keywords
- Labor Induction, Dexamethasone, Misoprostol, Term pregnancies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 7 Aug 2025 (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.
The aim of the study is to assess the effect of dexamethasone on labour induction in term pregnancies.
Primary outcome:
The interval between initiation of induction and beginning of the active phase of labour.
Secondary outcomes:
- Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation).
- Duration of second stage of labour
- Mode of delivery.
- Fetal outcome.
Group A:
Will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL).
Group B:
Will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h.
Group C:
Will receive one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h.
Detailed description
- Study type: Randomized Controlled Trial
- Population of study:
Pregnant women above 18 years of age, eligible for induction of labour.
● Study location: Cairo University Obstetrics \& Gynecology Hospital (Kasr Al-Ainy)
- Methodology in details:
- Every subject will be subjected to:
- Written consent.
- Complete history to exclude systemic disorders, congenital fetal malformation and contraindications for vaginal delivery.
- General examination of the patients including pulse, blood pressure and body mass index, [weight (kg)/ height (m2)] (20-25) normal weight, (25-30) overweight, (30-35) obese, (35-40) very obese and >40 morbid obese.
- Abdominal examination including presentation, station of fetal head, fetal heart rate, uterine contractions and exclusion of multiple pregnancies.
- Local examination to determine cervical dilatation at the beginning of intervention, presenting part, station of fetal head, pelvic adequacy and Bishop scoring.
- Sonographic examination including assessment of fetal well-being by biophysical profile.
- Patients will be randomly assigned to three groups using simple randomization via computer-generated random numbers will be used.
- The women will be divided into three groups:
- Group A: They will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL).
- Group B: They will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h.
- Group C: They will receive one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h.
- Regarding group A,B and C the investigators will wait 24hrs after the last dose, then reassessment by senior obstetrician will be done and if induction is unsuccessful it'll be determined whether the patient is for either CS or second 24hr attempt at induction by misoprostol.
- Primary outcome:
The interval between initiation of induction and beginning of the active phase of labour.
- Secondary outcomes:
- Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation).
- Duration of second stage of labour
- Mode of delivery.
- Fetal outcome.
- Sample size Assuming that the mean interval between the start of induction and the beginning of the active phase among cases 2.87±1.57 hours versus 3.8±1.72 hours among controls, so a minimum sample of 150 patients, divided into three equal groups (50 patients each), will achieve 80% power at 0.05 significance level. Sample size calculated using OpenEpi, Version 3, open source calculator-(SSMean).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1. Group A: They will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL). 2. Group B: They will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h. 3. Group C: They will receive one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h. * Regarding group A,B and C we will wait 24hrs after the last dose, then reassessment by senior obstetrician will be done and if induction is unsuccessful it'll be determined whether the patient is for either CS or second 24hr attempt at induction by misoprostol.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Dexamethasone (Decadron) 8mg IM injectionThey will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL). |
| Group B | Active comparator | Drug: Misoprostol 25 mcgThey will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h. |
| Group C | Experimental | Drug: Both Misoprostol 25 mcg & Dexamethasone 8mg IM injectionThey will receive one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years.
- Nulliparous.
- Vertex presentation.
- Singleton pregnancy.
- Gestational age ≥ 39 weeks according to a reliable date for the last menstrual period or a first-trimester ultrasound evaluation.
Key exclusion criteria (5 listed)
- Indication for cesarean section e. g. Placenta previa, intrauterine growth retardation, non-vertex presentation and previous cesarean section.
- Maternal medical disorders as diabetes mellitus and severe pre-eclampsia.
- Preterm labour and preterm rupture of membranes.
- Gestational age <39 weeks of gestation.
- Fetal macrosomia > 4kg (estimated by u/s).
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 (Decadron) 8mg IM injectionone dose of IM dexamethasone sodium phosphate 8 mg (2 mL) given at the start of labour induction | Drug | Group A |
| Misoprostol 25 mcgvaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h. | Drug | Group B |
| Both Misoprostol 25 mcg & Dexamethasone 8mg IM injectionone dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h. | Drug | Group C |
Primary outcome
The interval between initiation of induction and beginning of the active phase of labour.
Time frame: The interval between initiation of induction and beginning of the active phase of labour, assessed hourly up to 24 hours.
Assessed hourly
5 secondary outcomes
Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation).
Time frame: Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation), assessed hourly up to 24 hours.
Duration of second stage of labour
Time frame: Recorded immediately with delivery of the baby
Mode of delivery
Time frame: After induction attempt (24 hours)
Fetal outcome
Time frame: At 1 and 5 minutes after delivery
Fetal Outcome
Time frame: Recorded within 24 hours after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 39045936Vilas-Boas LS, Sanches MPR, Araujo Junior E, Peixoto AB, Mattar R, Santos LRRD, Pares DBDS, Sun SY. Evaluation of the efficacy of labor induction with vaginal misoprostol in a low-risk pregnant women population. Rev Assoc Med Bras (1992). 2024 Jul 19;70(7):e20240132. doi: 10.1590/1806-9282.20240132. eCollection 2024.
- Background: PubMed 26553085Laloha F, Asiabar NM, Barikani A, Movahed F, Haj Seyed Javadi E. Effect of Intravenous Dexamethasone on Preparing the Cervix and Labor Induction. Acta Med Iran. 2015;53(9):568-72.
- Background: PubMed 34404372Mohaghegh Z, Faal Siahkal S, Bahmaei H, Sharifipour F, Leyli EK, Zahedian M. The effect of dexamethasone on labor induction: a systematic review. BMC Pregnancy Childbirth. 2021 Aug 17;21(1):563. doi: 10.1186/s12884-021-04010-1.
- Background: PubMed 16625570Kavanagh J, Kelly AJ, Thomas J. Corticosteroids for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD003100. doi: 10.1002/14651858.CD003100.pub2.
- Individual participant dataSharing planned: Undecided. Confidentiality
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone (Decadron) 8mg IM injection, Misoprostol 25 mcg and Both Misoprostol 25 mcg & Dexamethasone 8mg IM injection in people with Labor Induction, run by Cairo 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelfatah M Eldesouky, MD, MRCOG (00201003370784, a.f.dessouki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The interval between initiation of induction and beginning of the active phase of labour. (time frame: The interval between initiation of induction and beginning of the active phase of labour, assessed hourly up to 24 hours.). 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 NCT07109258, which also lists 4 linked publications.
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 7 Aug 2025.