Labor FastEarly Phase 1NCT04482881
Isosorbide Mononitrate in Induction of Labour
A Early Phase 1 study testing Isosorbide Mononitrate 40 MG, Isosorbide Mononitrate 60 MG and Misoprostol in people with Labor Fast, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Induction of labor is defined as the process of artificially initiating uterine contractions, prior to their spontaneous onset, with progressive effacement and dilatation of the cervix and ultimately, the delivery of the baby. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Fast
- What is being tested?
- Isosorbide Mononitrate 40 MG, Isosorbide Mononitrate 60 MG and Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jul 2020to 25 Sep 2020
- Phase
- Early Phase 1
- 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single vertex presentation. 2. Gestational age > 37weeks calculated from last menstrual period or U/S scanning.
Who cannot join
- Patients with rupture of membranes.
- Previous uterine scar.
- Fetal malpresentation.
- Multiple pregnancies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Isosorbide Mononitrate and Misoprostol in Induction of Labour
Induction of labor is defined as the process of artificially initiating uterine contractions, prior to their spontaneous onset, with progressive effacement and dilatation of the cervix and ultimately, the delivery of the baby.
Read the detailed description
There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common cause.
- Conditions
- Labor Fast
- Being tested
- Isosorbide Mononitrate 40 MG, Isosorbide Mononitrate 60 MG, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide Mononitrate 40 MGDrug
giving women isosorbide mononitrate 40 MG
Isosorbide Mononitrate 60 MGDrug
giving women isosorbide mononitrate 60MG
MisoprostolDrug
Giving women misoprostol
| Study group | Role | What they receive |
|---|---|---|
| women receiving isosorbide mononitrates lower dose | Active comparator | women who will receive isosorbide mononitrates lower dose Receives: Drug: Isosorbide Mononitrate 40 MG |
| women receiving isosorbide mononitrates higher dose | Active comparator | women who will receive isosorbide mononitrates higher dose Receives: Drug: Isosorbide Mononitrate 60 MG |
| Women receiving misoprostol | Active comparator | Women who will receive misoprostol Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of women who will be reach active phase within 24 hours
how many women will reach active phase within 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start21 Jul 2020 (estimated)
- Primary completion20 Sep 2020 (estimated)
- Study completion25 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor FastStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Suez Canal University
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, PhD, Principal investigator, Algezeera hospitaland National Research Centre ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482881
- Sponsor's protocol ID
- labour induction
- Status last verified
- Jul 2020
- First submitted
- 19 Jul 2020
- Last updated
- 23 Jul 2020
- 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 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isosorbide Mononitrate and Misoprostol in Induction of Labour
- ClinicalTrials.gov ID
- NCT04482881
- Acronym / sponsor ID
- labour induction
- Conditions
- Labor Fast
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Suez Canal University
- Study start
- 21 Jul 2020 (estimated)
- Primary completion
- 20 Sep 2020 (estimated)
- Study completion
- 25 Sep 2020 (estimated)
- First posted
- 23 Jul 2020 (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.
Induction of labor is defined as the process of artificially initiating uterine contractions, prior to their spontaneous onset, with progressive effacement and dilatation of the cervix and ultimately, the delivery of the baby.
Detailed description
There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common cause.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| women receiving isosorbide mononitrates lower dose | Active comparator | Drug: Isosorbide Mononitrate 40 MGwomen who will receive isosorbide mononitrates lower dose |
| women receiving isosorbide mononitrates higher dose | Active comparator | Drug: Isosorbide Mononitrate 60 MGwomen who will receive isosorbide mononitrates higher dose |
| Women receiving misoprostol | Active comparator | Drug: MisoprostolWomen who will receive misoprostol |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Single vertex presentation. 2. Gestational age > 37weeks calculated from last menstrual period or U/S scanning.
Key exclusion criteria (4 listed)
- Patients with rupture of membranes.
- Previous uterine scar.
- Fetal malpresentation.
- Multiple pregnancies.
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 Mononitrate 40 MGgiving women isosorbide mononitrate 40 MG | Drug | women receiving isosorbide mononitrates lower dose |
| Isosorbide Mononitrate 60 MGgiving women isosorbide mononitrate 60MG | Drug | women receiving isosorbide mononitrates higher dose |
| MisoprostolGiving women misoprostol | Drug | Women receiving misoprostol |
Primary outcome
the number of women who will be reach active phase within 24 hours
Time frame: 24 hours
how many women will reach active phase within 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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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.
Mahmoud Alalfy, PhD principal investigator
Algezeera hospitaland National Research Centre ,Egypt
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 Isosorbide Mononitrate 40 MG, Isosorbide Mononitrate 60 MG and Misoprostol in people with Labor Fast, run by Aljazeera Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 23 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of women who will be reach active phase within 24 hours (time frame: 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 23 Jul 2020.