Labour InductionNCT02168881
Oral Misoprostol Versus Vaginal Dinoprostone For Induction Of Labour: A Randomized Controlled Clinical Trial
A study testing Misoprostol and Dinoprostone in people with Labour Induction, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study is to compare between oral misoprostol in solution and vaginal dinoprostone in induction of labour in primiparous women with singleton pregnancy as regards efficiency and safety to both mother and fetus. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labour Induction
- What is being tested?
- Misoprostol and Dinoprostone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteEgypt
- Study dates
- May 2014to Jan 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primigravida
- >37 wks
Who cannot join
- Scarred uterus
- Macrosomia
Trial locations and contacts
1 site in 1 country.
Marwan Osama Elkady contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity hospital
Cairo
Ain Shams, hospital
About this study
This study is to compare between oral misoprostol in solution and vaginal dinoprostone in induction of labour in primiparous women with singleton pregnancy as regards efficiency and safety to both mother and fetus.
- Conditions
- Labour Induction
- Being tested
- Misoprostol, Dinoprostone
- Keywords
- labour, induction, misoprostol, dinoprostone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
DinoprostoneDrug
| Study group | Role | What they receive |
|---|---|---|
| misoprostol | Active comparator | oral misoprostol in solution 25 microgram every 2 hours Receives: Drug: Misoprostol |
| dinoprostone | Active comparator | 3 mgs dinoprostone vaginally every six hours Receives: Drug: Dinoprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction delivery time
Measured: 2 hourly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2016 (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 InductionStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Elkady, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168881
- Sponsor's protocol ID
- Misoprostol-2014
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2014
- Last updated
- 20 Jun 2014
- Results posted
- No
Publications
Kerr RS, Kumar N, Williams MJ, Cuthbert A, Aflaifel N, Haas DM, Weeks AD. Low-dose oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2021 Jun 22;6(6):CD014484. doi: 10.1002/14651858.CD014484.
PubMed 34155622
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Misoprostol Versus Vaginal Dinoprostone For Induction Of Labour: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02168881
- Acronym / sponsor ID
- Misoprostol-2014
- Conditions
- Labour Induction
- Keywords
- labour, induction, misoprostol, dinoprostone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2016 (estimated)
- First posted
- 20 Jun 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.
This study is to compare between oral misoprostol in solution and vaginal dinoprostone in induction of labour in primiparous women with singleton pregnancy as regards efficiency and safety to both mother and fetus.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| misoprostol | Active comparator | Drug: Misoprostoloral misoprostol in solution 25 microgram every 2 hours |
| dinoprostone | Active comparator | Drug: Dinoprostone3 mgs dinoprostone vaginally every six hours |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Primigravida
- >37 wks
Key exclusion criteria (2 listed)
- Scarred uterus
- Macrosomia
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 |
|---|---|---|
| Misoprostol | Drug | misoprostol |
| Dinoprostone | Drug | dinoprostone |
Primary outcome
induction delivery time
Time frame: 2 hourly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
- Derived from this study: PubMed 34155622Kerr RS, Kumar N, Williams MJ, Cuthbert A, Aflaifel N, Haas DM, Weeks AD. Low-dose oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2021 Jun 22;6(6):CD014484. doi: 10.1002/14651858.CD014484.
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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.
Marwan Osama Elkady contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol and Dinoprostone in people with Labour Induction, 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 2 inclusion and 2 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 20 Jun 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.
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 Marwan Osama Elkady (+201205533315), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
induction delivery time (time frame: 2 hourly). 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 NCT02168881, 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 20 Jun 2014.