Induction of LaborPhase 2NCT03854383
Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women
A Phase 2 study testing Isosorbide mononitrate and Misoprostol in people with Induction of Labor, run by Abdelrahman Ali Fadel Youssef Mohamed at 1 site in Egypt.
Trial summary
We will compare between using isosorbide mononitrate together with misoprostol versus the misoprostol alone in induction of labor in postdate women Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor
- What is being tested?
- Isosorbide mononitrate and Misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2019to 1 Jul 2019
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- age (20-35 yrs)
- single fetus
- gestational age > 40weeks
- not in labor
- bishop score < 7
- no medical disorder
Who cannot join
- Gestational age ≤40 weeks
- patient with a ripe cervix
- rupture of membranes
- suspected chorioamnionitis
- placenta previa
- history of major uterine surgery
Show all 12Show fewer
- hypertonic uterine pattern
- contraindicated to receive PG
- fetal malpresentation
- multiple pregnancy
- intrauterine growth retardation
- women with any general medical disorder
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams maternity hospital
Cairo, 11517
Saed Mousa, PhD, 1008687700 ext. +20, drsaedmousa1@gmail.com
About this study
Official title: Efficacy of Intravaginal Administration of Isosorbide Mononitrate Together With Misoprostol Versus Misoprostol Alone in Induction of Labor in Postdate Women
We will compare between using isosorbide mononitrate together with misoprostol versus the misoprostol alone in induction of labor in postdate women
- Conditions
- Induction of Labor
- Being tested
- Isosorbide mononitrate, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide mononitrateDrug
Administration of isosorbide mononitrate vaginaly together with misoprostol in induction of labor in postdate women
MisoprostolDrug
Used intravaginally to ripe the cevix in induction of labor
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol alone | Sham comparator | Enrolled women will receive 25 πg of misoprostol which will be placed intravaginally 4 hourly, maximum up to 5 doses Receives: Drug: Misoprostol |
| Isosorbide mononitrate with misoprostol | Active comparator | Enrolled women will receive 25 πg of misoprostol together with 40 mg isosorbide mononitrate which will be placed intravaginally 4 hourly, maximum up to 5 doses Receives: Drug: Isosorbide mononitrate; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of induction to active phase interval
Measure the time between the beginning of the induction to enter the active phase of labor
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start3 Mar 2019
- Primary completion1 May 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdelrahman Ali Fadel Youssef Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrahman Ali Fadel Youssef Mohamed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854383
- Sponsor's protocol ID
- 600181
- Status last verified
- Mar 2019
- First submitted
- 20 Feb 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravaginal Administration of Isosorbide Mononitrate Together With Misoprostol Versus Misoprostol Alone in Induction of Labor in Postdate Women
- ClinicalTrials.gov ID
- NCT03854383
- Acronym / sponsor ID
- 600181
- Conditions
- Induction of Labor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Abdelrahman Ali Fadel Youssef MohamedUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 26 Feb 2019 (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.
We will compare between using isosorbide mononitrate together with misoprostol versus the misoprostol alone in induction of labor in postdate women
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol alone | Sham comparator | Drug: MisoprostolEnrolled women will receive 25 πg of misoprostol which will be placed intravaginally 4 hourly, maximum up to 5 doses |
| Isosorbide mononitrate with misoprostol | Active comparator | Drug: Isosorbide mononitrate, Drug: MisoprostolEnrolled women will receive 25 πg of misoprostol together with 40 mg isosorbide mononitrate which will be placed intravaginally 4 hourly, maximum up to 5 doses |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age (20-35 yrs)
- single fetus
- gestational age > 40weeks
- not in labor
- bishop score < 7
Key exclusion criteria (12 listed)
- Gestational age ≤40 weeks
- patient with a ripe cervix
- rupture of membranes
- suspected chorioamnionitis
- placenta previa
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 mononitrateAdministration of isosorbide mononitrate vaginaly together with misoprostol in induction of labor in postdate women | Drug | Isosorbide mononitrate with misoprostol |
| MisoprostolUsed intravaginally to ripe the cevix in induction of labor | Drug | Isosorbide mononitrate with misoprostol, Misoprostol alone |
Primary outcome
The duration of induction to active phase interval
Time frame: 12 weeks
Measure the time between the beginning of the induction to enter the active phase of labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
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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 2 study testing Isosorbide mononitrate and Misoprostol in people with Induction of Labor, run by Abdelrahman Ali Fadel Youssef Mohamed 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 12 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 12 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The duration of induction to active phase interval (time frame: 12 weeks). 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 12 Mar 2019.