Cervical Ripening and Induction of LaborEarly Phase 1NCT06874049
Comparison Between Vaginal Misoprostol Gel and Oral Misoprostol Solution in Induction of Labor
A Early Phase 1 study testing Vaginal misoprostol and Oral misoprostol solution (OMS) in people with Cervical Ripening and Induction of Labor, run by Hagar Muhammad Abdulfattah Muhammad at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to study the efficacy of vaginal versus oral misoprostol solution in cervical ripening for induction of labor. The main questions it aims to answer is : is Vaginal misoprostol solution as effective as oral misoprostol solution for induction of labor? Researchers will compare oral… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Ripening and Induction of Labor
- What is being tested?
- Vaginal misoprostol and Oral misoprostol solution (OMS)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Feb 2025to 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with a singleton pregnancy.
- Cephalic presentation.
- Age range: 18-40 years.
- Gestational age between 36 and 42 weeks.
- Intact fetal membranes.
- Absence of spontaneous uterine contractions.
- Non favorable cervix (Bishop score ≤ 5).
- A reactive non stress test in case of positive fetal life.
Who cannot join
- History of cesarean section or uterine scars
- Grand Multipara P ≥5
- Known fetal non-cephalic presentation
- Any known allergy to misoprostol.
- Multiple pregnancy
- Contraindication to vaginal delivery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Versus Vaginal Misoprostol Solution Among Pregnant Women Undergoing Induction of Labor At Ain Shams University Maternity Hospital a Randomized Controlled Trial
The goal of this clinical trial is to study the efficacy of vaginal versus oral misoprostol solution in cervical ripening for induction of labor.
The main questions it aims to answer is : is Vaginal misoprostol solution as effective as oral misoprostol solution for induction of labor? Researchers will compare oral Misoprostol Solution and vaginal misoprostol solution prepared by KY gel Participants will then be randomized into two groups using a computer-generated randomization list , the first group will receive oral solution equal to 25 microgram misoprostol every 2 hours while the second group will receive 25 microgram vaginal misoprostol solution every 4 hours The cervix will be assessed and scored at each examination. They will be reviewed before the stipulated time if they were contracting. The administration of the drugs will be discontinued when a favorable cervix is diagnosed (modified Bishop score ≥6 ) or 24 hours of study drug had been given.
- Conditions
- Cervical Ripening and Induction of Labor
- Being tested
- Vaginal misoprostol, Oral misoprostol solution (OMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal misoprostolDrug
the vaginal misoprostol solution will be prepared by complete crushing of one misoprostol 200 µg tablet into powder then adding the powder into a clean urine specimen cup then adding 20 cc of KY gel measured by a 20 ml syringe then mix the contents together to ensure adequate distribution of the powder , each patient will receive only 2.5cc of the mixture vaginally (inserted into the posterior fornix,) by using medical 3ml syringes equal to 25 mcg misoprostol 4 hourly according to International Federation of Gynecology and Obstetrics (FIGO2023) and remain recumbent for 10-20 minutes
Oral misoprostol solution (OMS)Drug
the solution will be prepared by dissolving one 200 µg tablet in 200 ml of tap water , each member will receive 25 cc misoprostol solution equal to 25 mcg misoprostol 2 hourly according to International Federation of Gynecology and Obstetrics (FIGO2023)
| Study group | Role | What they receive |
|---|---|---|
| vaginal misoprostol solution | Experimental | the vaginal solution will be prepared by complete crushing of one misoprostol 200 µg tablet into powder then adding the powder into a clean urine specimen cup then adding 20 cc of KY gel measured by a 20 ml syringe then mix the contents together to ensure adequate distribution of the powder , each patient will receive only 2.5cc of the mixture vaginally (inserted into the posterior fornix,) by using medical 3ml syringes equal to 25 mcg misoprostol 4 hourly according to International Federation of Gynecology and Obstetrics (FIGO2023) and remain recumbent for 10-20 minutes. Receives: Drug: Vaginal misoprostol |
| oral misoprostol solution | Active comparator | the first group the solution will be prepared by dissolving one 200 µg tablet in 200 ml of tap water , each member will receive 25 cc misoprostol solution equal to 25 mcg misoprostol 2 hourly according to International Federation of Gynecology and Obstetrics (FIGO2023). Receives: Drug: Oral misoprostol solution (OMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is induction to cervical ripening (Bishop score ≥6) time interval.
Measured: 24 hours max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start26 Feb 2025
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Ripening and Induction of LaborStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hagar Muhammad Abdulfattah Muhammad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hagar Muhammad Abdulfattah Muhammad, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874049
- Sponsor's protocol ID
- 1525
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Vaginal Misoprostol Solution Among Pregnant Women Undergoing Induction of Labor At Ain Shams University Maternity Hospital a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06874049
- Acronym / sponsor ID
- 1525
- Conditions
- Cervical Ripening and Induction of Labor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hagar Muhammad Abdulfattah MuhammadUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 13 Mar 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 goal of this clinical trial is to study the efficacy of vaginal versus oral misoprostol solution in cervical ripening for induction of labor.
The main questions it aims to answer is : is Vaginal misoprostol solution as effective as oral misoprostol solution for induction of labor? Researchers will compare oral Misoprostol Solution and vaginal misoprostol solution prepared by KY gel Participants will then be randomized into two groups using a computer-generated randomization list , the first group will receive oral solution equal to 25 microgram misoprostol every 2 hours while the second group will receive 25 microgram vaginal misoprostol solution every 4 hours The cervix will be assessed and scored at each examination. They will be reviewed before the stipulated time if they were contracting. The administration of the drugs will be discontinued when a favorable cervix is diagnosed (modified Bishop score ≥6 ) or 24 hours of study drug had been given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaginal misoprostol solution | Experimental | Drug: Vaginal misoprostolthe vaginal solution will be prepared by complete crushing of one misoprostol 200 µg tablet into powder then adding the powder into a clean urine specimen cup then adding 20 cc of KY gel measured by a 20 ml syringe then mix the contents together to ensure adequate distribution of the powder , each patient will receive only 2.5cc of the mixture vaginally (inserted into the posterior fornix,) by using medical 3ml syringes equal to 25 mcg misoprostol 4 hourly according to International Federation of Gynecology and Obstetrics (FIGO2023) and remain recumbent for 10-20 minutes. |
| oral misoprostol solution | Active comparator | Drug: Oral misoprostol solution (OMS)the first group the solution will be prepared by dissolving one 200 µg tablet in 200 ml of tap water , each member will receive 25 cc misoprostol solution equal to 25 mcg misoprostol 2 hourly according to International Federation of Gynecology and Obstetrics (FIGO2023). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women with a singleton pregnancy.
- Cephalic presentation.
- Age range: 18-40 years.
- Gestational age between 36 and 42 weeks.
- Intact fetal membranes.
Key exclusion criteria (6 listed)
- History of cesarean section or uterine scars
- Grand Multipara P ≥5
- Known fetal non-cephalic presentation
- Any known allergy to misoprostol.
- Multiple pregnancy
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 |
|---|---|---|
| Vaginal misoprostolthe vaginal misoprostol solution will be prepared by complete crushing of one misoprostol 200 µg tablet into powder then adding the powder into a clean urine specimen cup then adding 20 cc of KY gel measured by a 20 ml syringe then mix the contents together to ensure adequate distribution of the powder , each patient will receive only 2.5cc of the mixture vaginally (inserted into the posterior fornix,) by using medical 3ml syringes equal to 25 mcg misoprostol 4 hourly according to International Federation of Gynecology and Obstetrics (FIGO2023) and remain recumbent for 10-20 minutes | Drug | vaginal misoprostol solution |
| Oral misoprostol solution (OMS)the solution will be prepared by dissolving one 200 µg tablet in 200 ml of tap water , each member will receive 25 cc misoprostol solution equal to 25 mcg misoprostol 2 hourly according to International Federation of Gynecology and Obstetrics (FIGO2023) | Drug | oral misoprostol solution |
Primary outcome
The primary outcome measure is induction to cervical ripening (Bishop score ≥6) time interval.
Time frame: 24 hours max
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 13 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vaginal misoprostol and Oral misoprostol solution (OMS) in people with Cervical Ripening and Induction of Labor, run by Hagar Muhammad Abdulfattah Muhammad 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 8 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 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?
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?
The primary outcome measure is induction to cervical ripening (Bishop score ≥6) time interval. (time frame: 24 hours max). 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 13 Mar 2025.