Induction of Labor Affected Fetus / NewbornPhase 4NCT03544606
Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor
A Phase 4 study testing isosorbide mononitrate in people with Induction of Labor Affected Fetus / Newborn, run by ahmed nagy shaker ramadan at 1 site in Egypt.
Trial summary
The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- isosorbide mononitrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 30 Jun 2024
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy.
- Cephalic presentation.
- Bishop score < 6.
- Average size of the fetus.
- Adequate pelvic dimensions.
- Term or post-term pregnancies with an indication for labor induction either maternal or fetal.
Who cannot join
- • Previous uterine scar.
- Patients with regular uterine contractions.
- Malpresentation.
- Multifetal gestation.
- Prelabour rupture of membranes.
- Established fetal distress.
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- Indication for CS, e.g. Major degree of cephalopelvic disproportion and fetal macrosomia.
- Antepartum hemorrhage.
- Active genital herpes infection.
- Severe maternal illness (e.g. severe preeclampsia).
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor.
Research Hypothesis:
In women undergoing induction of labor, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery.
Research Questions:
Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor?
Read the detailed description
- Type of Study : Prospective double blind randomized controlled clinical trial.
- Study Setting : This study will be conducted in Kafr Elsheikh University maternity hospital.
- Study Period : Expected 6 months from December 2023 to June 2024.
- Study Population : Patients will be recruited in this study those attending labor ward at Kafr Elsheikh hospital for induction of labor at term or post-term with unripe cervix (Bishop Score ˂ 6).
- Being tested
- isosorbide mononitrate, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isosorbide mononitrateDrug
Also called Effox 40 mg
40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses.
PlacebosDrug
Also called pyridoxine
In placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given
| Study group | Role | What they receive |
|---|---|---|
| isosorbide mononitrate group | Experimental | In vaginal IMN group (group 1) 40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses. Receives: Drug: isosorbide mononitrate |
| placebos group | Placebo comparator | In the placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
admission-delivery interval
The time from initiation labor induction and delivery of placenta
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Dec 2023
- Primary completion15 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be divided into 2 groups. Group 1: 80 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM) Group 2: 80 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- ahmed nagy shaker ramadan
- Sponsor type
- University, hospital or other
- Collaborators
- Kafrelsheikh University
- Responsible party
- Sponsor-investigator, ahmed nagy shaker ramadan, Cairo University
- Investigators
- Ahmed N Shaker, MD, Principal investigator, faculty of medicine - Kafr elsheikh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544606
- Sponsor's protocol ID
- ISMN and labor induction
- Status last verified
- Aug 2024
- First submitted
- 18 May 2018
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data supporting this research is available upon request. Please contact corresponding Author at ahmedafifi38527@postgrad.kasralainy.edu.eg for access to the relevant datasets. We are committed to transparency and facilitating the reproducibility of our findings, and we welcome inquiries regarding the data used in this study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor
- ClinicalTrials.gov ID
- NCT03544606
- Acronym / sponsor ID
- ISMN and labor induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- ahmed nagy shaker ramadanUniversity, hospital or other
- Collaborators
- Kafrelsheikh University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 4 Jun 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.
The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor.
Research Hypothesis:
In women undergoing induction of labor, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery.
Research Questions:
Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor?
Detailed description
- Type of Study : Prospective double blind randomized controlled clinical trial.
- Study Setting : This study will be conducted in Kafr Elsheikh University maternity hospital.
- Study Period : Expected 6 months from December 2023 to June 2024.
- Study Population : Patients will be recruited in this study those attending labor ward at Kafr Elsheikh hospital for induction of labor at term or post-term with unripe cervix (Bishop Score ˂ 6).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The patients will be divided into 2 groups. Group 1: 80 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM) Group 2: 80 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.
| Arm | Type | Receives |
|---|---|---|
| isosorbide mononitrate group | Experimental | Drug: isosorbide mononitrateIn vaginal IMN group (group 1) 40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses. |
| placebos group | Placebo comparator | Drug: PlacebosIn the placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Singleton pregnancy.
- Cephalic presentation.
- Bishop score < 6.
- Average size of the fetus.
- Adequate pelvic dimensions.
Key exclusion criteria (10 listed)
- • Previous uterine scar.
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 |
|---|---|---|
| isosorbide mononitrateAlso: Effox 40 mg40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses. | Drug | isosorbide mononitrate group |
| PlacebosAlso: pyridoxineIn placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given | Drug | placebos group |
Primary outcome
admission-delivery interval
Time frame: up to 24 hours
The time from initiation labor induction and delivery of placenta
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No. The data supporting this research is available upon request. Please contact corresponding Author at ahmedafifi38527@postgrad.kasralainy.edu.eg for access to the relevant datasets. We are committed to transparency and facilitating the reproducibility of our findings, and we welcome inquiries regarding the data used in this study.
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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.
Ahmed N Shaker, MD principal investigator
faculty of medicine - Kafr elsheikh university
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 isosorbide mononitrate in people with Induction of Labor Affected Fetus / Newborn, run by ahmed nagy shaker ramadan 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 10 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 22 Aug 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
admission-delivery interval (time frame: up to 24 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 22 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.