Labour,InducedPhase 2NCT03927807
Oral Misoprostol Solution in Labor Induction
A Phase 2 study testing Misoprostol in people with Labour,Induced, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study compares safety and efficacy between repetitive hourly dose of oral misoprostol and two hourly dose oral regimens for cervical ripening and labor induction. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour,Induced
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Mar 2019to 18 Jan 2020
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nulliparas
- Term pregnancy(equal or more than 37 wks)
- Bishop score <6
- Cephalic presentation
- reassuring fetal heart rate pattern
- Not in labor ( no uterine contractions)
- Clinically adequate pelvis
- Singleton live pregnancy
Who cannot join
- Allergic to misoprostol or prostaglandin analogues
- Previous uterine scar( cesarean section,hysterotomy,myomectomy)
- Multiple fetal gestations
- Fetal demise
- Preterm labor
- Malpresentations
Show all 9Show fewer
- Non reactive cardiotocography at admission
- Cephalo pelvic disproportion
- Fetal macrosomia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Cairo Governorate, 002
esam sa hagag, MBBCh, 01066813830, essamhagag742@yahoo.com
About this study
Official title: A Comparison of the Efficacy and Safety of Repetitive Hourly Dose of Oral Misoprostol and Two Hourly Dose Oral Regimens for Cervical Ripening and Labor Induction
This study compares safety and efficacy between repetitive hourly dose of oral misoprostol and two hourly dose oral regimens for cervical ripening and labor induction.
Read the detailed description
Misoprostol is an effective agent for the induction of labor.existing guidelines recommend oral misoprostol solution every two hours.However,more research is required to optimize the use of oral misoprostol solution for labor induction.The current study is to compare efficacy and safety of repetitive hourly dose of oral misoprostol solution with two hourly dose of oral misoprostol solution for cervical ripening and labor induction.
- Conditions
- Labour,Induced
- Being tested
- Misoprostol
- Keywords
- misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
This study will include 150 pregnant women who fulfill the inclusion criteria and will be subdivided in two groups.
Group1 will receive repetitive hourly dose of oral misoprostol solution equal to 10 microgram up to 12 doses or regular uterine activity.
Group2 will receive oral misoprostol solution every two hours as 20 microgram up to 6 doses or regular uterine activity.
| Study group | Role | What they receive |
|---|---|---|
| repetitive hourly dose of oral misoprostol | Experimental | The dose will be 10 microgram oral misoprostol that will be administered hourly up to 12 doses or till onset of regular uterine activity. Receives: Drug: Misoprostol |
| two hourly dose of oral misoprostol | Experimental | The dose will be 20 microgram oral misoprostol solution that will be administered every 2 hours up to 6 doses or till onset of regular uterine activity. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of delivery
Successful vaginal delivery within 24 hours from starting induction of labor or cesarean section delivery after failed trial of induction.
Measured: 24 hours from the first dose of induction till delivery
Secondary outcomes (2)
Adverse maternal outcomes
As uterine hyper stimulation,fever,vomiting,shivering,nausea
Measured: in 24 hours
Adverse neonatal outcomes
As neonatal intensive care unit admission,non reassuring fetal heart rate
Measured: 24 hours post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start18 Mar 2019
- Primary completion18 Dec 2019 (estimated)
- Study completion18 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labour,InducedStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esam salah mohamed hagag, Ain Shams University
- Investigators
- essam sa hagag, MBBCh, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927807
- Sponsor's protocol ID
- misoprostol in induction
- Status last verified
- Apr 2019
- First submitted
- 20 Apr 2019
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be available.
Publications
27986461
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy and Safety of Repetitive Hourly Dose of Oral Misoprostol and Two Hourly Dose Oral Regimens for Cervical Ripening and Labor Induction
- ClinicalTrials.gov ID
- NCT03927807
- Acronym / sponsor ID
- misoprostol in induction
- Conditions
- Labour,Induced
- Keywords
- misoprostol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 18 Dec 2019 (estimated)
- Study completion
- 18 Jan 2020 (estimated)
- First posted
- 25 Apr 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.
This study compares safety and efficacy between repetitive hourly dose of oral misoprostol and two hourly dose oral regimens for cervical ripening and labor induction.
Detailed description
Misoprostol is an effective agent for the induction of labor.existing guidelines recommend oral misoprostol solution every two hours.However,more research is required to optimize the use of oral misoprostol solution for labor induction.The current study is to compare efficacy and safety of repetitive hourly dose of oral misoprostol solution with two hourly dose of oral misoprostol solution for cervical ripening and labor induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| repetitive hourly dose of oral misoprostol | Experimental | Drug: MisoprostolThe dose will be 10 microgram oral misoprostol that will be administered hourly up to 12 doses or till onset of regular uterine activity. |
| two hourly dose of oral misoprostol | Experimental | Drug: MisoprostolThe dose will be 20 microgram oral misoprostol solution that will be administered every 2 hours up to 6 doses or till onset of regular uterine activity. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Nulliparas
- Term pregnancy(equal or more than 37 wks)
- Bishop score <6
- Cephalic presentation
- reassuring fetal heart rate pattern
Key exclusion criteria (9 listed)
- Allergic to misoprostol or prostaglandin analogues
- Previous uterine scar( cesarean section,hysterotomy,myomectomy)
- Multiple fetal gestations
- Fetal demise
- Preterm labor
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 |
|---|---|---|
| MisoprostolThis study will include 150 pregnant women who fulfill the inclusion criteria and will be subdivided in two groups. Group1 will receive repetitive hourly dose of oral misoprostol solution equal to 10 microgram up to 12 doses or regular uterine activity. Group2 will receive oral misoprostol solution every two hours as 20 microgram up to 6 doses or regular uterine activity. | Drug | repetitive hourly dose of oral misoprostol, two hourly dose of oral misoprostol |
Primary outcome
Mode of delivery
Time frame: 24 hours from the first dose of induction till delivery
Successful vaginal delivery within 24 hours from starting induction of labor or cesarean section delivery after failed trial of induction.
2 secondary outcomes
Adverse maternal outcomes
Time frame: in 24 hours
Adverse neonatal outcomes
Time frame: 24 hours post partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Results publication27986461
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be available.
Related trials for Labour,Induced
Not yet recruitingObservational study
Prediction of Intrapartum Fetal Compromise After Elective Induction of Labour
Intrapartum Fetal Distress
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Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
Induced Labor, Cervical Ripening
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Intravenous Papaverine for Term Prelabor Rupture of Membranes
Premature Rupture of Fetal Membranes
Not yet recruiting
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
Induced; Birth
Not yet recruitingObservational study
Pelvic Floor Ultrasound Before Induction of Labour and Labour Outcome
Labor, Pelvic Floor Disorder
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.
essam sa hagag, MBBCh principal investigator
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 2 study testing Misoprostol in people with Labour,Induced, 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 8 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 25 Apr 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. 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?
Contact essam sa hagag, MBBCh (01066813830, essamhagag742@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mode of delivery (time frame: 24 hours from the first dose of induction till delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03927807, which also lists 1 linked publication.
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 25 Apr 2019.