Medical Induction of Labor Affecting FetusPhase 3NCT02036437
Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor
A Phase 3 study testing Misotac® Sigma Pharmaceutical Industries and Dinoprostone 3 mg in people with Medical Induction of Labor Affecting Fetus, run by Ain Shams University at 1 site in Egypt.
Trial summary
To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone for labor induction. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Induction of Labor Affecting Fetus
- What is being tested?
- Misotac® Sigma Pharmaceutical Industries and Dinoprostone 3 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2013to Sep 2015
- Phase
- Phase 3
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Single vertex presentation.
- Gestational age > 37 weeks calculated from last menstrual period or U/S scanning.
- Bishop score <8 .
- Not in labor.
- Reassuring fetal heart rate (CTG for 20 min on the day of induction).
- Valid indication for Induction of labor.
Who cannot join
- Gestational age <37 weeks.
- Patients with rupture of membranes.
- Previous uterine scar.
- Fetal malpresentation.
- Multiple pregnancy.
- Significant antepartum hemorrhage
Show all 9Show fewer
- Uncontrolled DM.
- Severe Pre-eclampsia or Eclampsia
- If there are contraindications to receive the drugs, e.g. allergy, history of severe asthma,…..etc.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
New Maternity Hospital - Ain Shams university
Cairo, Cairo Governorate, 11666
Amr H Yehia, MD,MRCOG, 01227900014 ext. 002, am_helmy77@hotmail.com
Sherif E Daoud, MB.Bch. Msc
About this study
Official title: Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor: a Randomized Control Trial
To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone for labor induction.
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 indication. It is well recognized that with an unripe cervix, induction may be difficult and often unsuccessful. The use of an agent to ripen the cervix prior to induction is acceptable in the modern practice.
- Misoprostol, a prostaglandin E1 analogue, is the most interesting alternative to Dinoprostone because of its effectiveness, low cost, and temperature stability. It ripens the cervix by inducing regular uterine contractions. However, it is associated with several adverse effects especially uterine hyperstimulation, which is painful and may result in fetal compromise.
- Testing the efficacy and safety of titrated oral misoprostol versus vaginal dinoprostone may develop a new safe and effective method for labor induction.
- Being tested
- Misotac® Sigma Pharmaceutical Industries, Dinoprostone 3 mg
- Keywords
- Induction of Labor, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misotac® Sigma Pharmaceutical IndustriesDrug
Also called Misotac (Misoprostol)
The solution will be orally administrated every two hours (maximum 12 hours) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose of 20 ml (20 ug) will be increased to 40 ml (40ug) after two doses if there are no contractions. The timing and strength of contractions will be assessed by abdominal palpation. If the contractions are inadequate, augmentation of the active phase of labor will be attempted by hourly-titrated oral misoprostol (20 ml) +/- amniotomy. If the uterine contractions are judged to be adequate, the next dose of misoprostol will be omitted.
Dinoprostone 3 mgDrug
Also called Dinoglandin®
Dinoprostone 3 mg (Dinoglandin® Alexandria Co. for Pharmaceuticals) will be inserted in the posterior vaginal fornix and repeated after six hours if contractions are inadequate (i.e. two doses maximum). If the contractions become inadequate, augmentation of the active phase of labor will be attempted by Syntocinon (oxytocin) infusion +/- amniotomy.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | A dose of 20ug is required obtained by dissolving the 200ug tablet (Misotac® Sigma Pharmaceutical Industries) in 200 ml water (1ug per ml), the solution is shaked well before each administration. The solution will be orally administrated every two hours (max. 12 hrs) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose will be increased to 40 ml (40ug) after two doses if there are no contractions. The timing and strength of contractions will be assessed by abdominal palpation. If the contractions are inadequate, augmentation of the active phase of labor will be attempted by hourly-titrated oral misoprostol (20 ml) +/- amniotomy. Receives: Drug: Misotac® Sigma Pharmaceutical Industries |
| Control | Active comparator | Dinoprostone 3 mg (Dinoglandin® Alexandria Co. for Pharmaceuticals) will be inserted in the posterior vaginal fornix and repeated after six hours if contractions are inadequate (i.e. two doses maximum). If the contractions become inadequate, augmentation of the active phase of labor will be attempted by Syntocinon (oxytocin) infusion +/- amniotomy. Receives: Drug: Dinoprostone 3 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction delivery interval i.e. Time from start of medication till delivery
Measured: 24 hours
Secondary outcomes (6)
Patients delivered vaginally within the first 24 hours
Measured: 24 hours
Time from start of labor augmentation by either misoprostol or Syntocinon (oxytocin) to active phase of labor
Measured: 12 hours
Duration of 1st,2nd and 3rd stages of labor
Measured: 24 hours
Maternal complications
uterine hyperstimulation, postpartum hemorrhage, uterine rupture, sepsis, shivering, headache, nausea, vomiting, and retained placenta.
Measured: 24 hours
Mode of delivery
Vaginal , instrumental or Cesarean section
Measured: 24 hours
Neonatal outcome
Apgar score at 1 and 5 minutes and Neonatal Intensive Care Unit admission
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 posted15 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Induction of Labor Affecting FetusStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Essam, Ain Shams University
- Investigators
- Amr H Yehia, MD, MRCOG, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036437
- Sponsor's protocol ID
- elkont1984
- Status last verified
- Feb 2014
- First submitted
- 13 Jan 2014
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02036437
- Acronym / sponsor ID
- elkont1984
- Keywords
- Induction of Labor, Misoprostol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 15 Jan 2014 (estimated)
- 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.
To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone for labor induction.
Detailed description
- There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common indication. It is well recognized that with an unripe cervix, induction may be difficult and often unsuccessful. The use of an agent to ripen the cervix prior to induction is acceptable in the modern practice.
- Misoprostol, a prostaglandin E1 analogue, is the most interesting alternative to Dinoprostone because of its effectiveness, low cost, and temperature stability. It ripens the cervix by inducing regular uterine contractions. However, it is associated with several adverse effects especially uterine hyperstimulation, which is painful and may result in fetal compromise.
- Testing the efficacy and safety of titrated oral misoprostol versus vaginal dinoprostone may develop a new safe and effective method for labor induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Drug: Misotac® Sigma Pharmaceutical IndustriesA dose of 20ug is required obtained by dissolving the 200ug tablet (Misotac® Sigma Pharmaceutical Industries) in 200 ml water (1ug per ml), the solution is shaked well before each administration. The solution will be orally administrated every two hours (max. 12 hrs) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose will be increased to 40 ml (40ug) after two doses if there are no contractions. The timing and strength of contractions will be assessed by abdominal palpation. If the contractions are inadequate, augmentation of the active phase of labor will be attempted by hourly-titrated oral misoprostol (20 ml) +/- amniotomy. |
| Control | Active comparator | Drug: Dinoprostone 3 mgDinoprostone 3 mg (Dinoglandin® Alexandria Co. for Pharmaceuticals) will be inserted in the posterior vaginal fornix and repeated after six hours if contractions are inadequate (i.e. two doses maximum). If the contractions become inadequate, augmentation of the active phase of labor will be attempted by Syntocinon (oxytocin) infusion +/- amniotomy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Single vertex presentation.
- Gestational age > 37 weeks calculated from last menstrual period or U/S scanning.
- Bishop score <8 .
- Not in labor.
- Reassuring fetal heart rate (CTG for 20 min on the day of induction).
Key exclusion criteria (9 listed)
- Gestational age <37 weeks.
- Patients with rupture of membranes.
- Previous uterine scar.
- Fetal malpresentation.
- 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 |
|---|---|---|
| Misotac® Sigma Pharmaceutical IndustriesAlso: Misotac (Misoprostol)The solution will be orally administrated every two hours (maximum 12 hours) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose of 20 ml (20 ug) will be increased to 40 ml (40ug) after two doses if there are no contractions. The timing and strength of contractions will be assessed by abdominal palpation. If the contractions are inadequate, augmentation of the active phase of labor will be attempted by hourly-titrated oral misoprostol (20 ml) +/- amniotomy. If the uterine contractions are judged to be adequate, the next dose of misoprostol will be omitted. | Drug | Cases |
| Dinoprostone 3 mgAlso: Dinoglandin®Dinoprostone 3 mg (Dinoglandin® Alexandria Co. for Pharmaceuticals) will be inserted in the posterior vaginal fornix and repeated after six hours if contractions are inadequate (i.e. two doses maximum). If the contractions become inadequate, augmentation of the active phase of labor will be attempted by Syntocinon (oxytocin) infusion +/- amniotomy. | Drug | Control |
Primary outcome
Induction delivery interval i.e. Time from start of medication till delivery
Time frame: 24 hours
6 secondary outcomes
Patients delivered vaginally within the first 24 hours
Time frame: 24 hours
Time from start of labor augmentation by either misoprostol or Syntocinon (oxytocin) to active phase of labor
Time frame: 12 hours
Duration of 1st,2nd and 3rd stages of labor
Time frame: 24 hours
Maternal complications
Time frame: 24 hours
Mode of delivery
Time frame: 24 hours
Neonatal outcome
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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.
Amr H Yehia, MD, MRCOG study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misotac® Sigma Pharmaceutical Industries and Dinoprostone 3 mg in people with Medical Induction of Labor Affecting Fetus, run by Ain Shams 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 9 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 19 Feb 2014. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Induction delivery interval i.e. Time from start of medication till delivery (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 19 Feb 2014; AzTrials last refreshed its copy on 7 Nov 2026.