Induced LaborPhase 2NCT02685085
Combined Method for Induction of Labor
A Phase 2 study testing Misoprostol ( Prostaglandin E2) and Foley's catheter in people with Induced Labor, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
Induction of labor is performed via the vaginal misorostol 25 ug/ 6 hours and intracervical foley's cather administration and both techniques performed together. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Labor
- What is being tested?
- Misoprostol ( Prostaglandin E2) and Foley's catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2016to Aug 2016
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- females presenting for induction of labor
Who cannot join
- previous cesarean section
- previous uterine scars e.g. myomectomy
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr el aini hospital
Cairo, Cairo Governorate, 12211
Dina M Dakhly, MD, 01003498919 ext. 002, Dinadakhly@gmail.com
Dina M Dakhly, MD
About this study
Induction of labor is performed via the vaginal misorostol 25 ug/ 6 hours and intracervical foley's cather administration and both techniques performed together.
- Conditions
- Induced Labor
- Being tested
- Misoprostol ( Prostaglandin E2), Foley's catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol ( Prostaglandin E2)Drug
Also called Cytotec
Foley's catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | in this group misoprostol 25 ug will be administrated for induction of labor every 6 hours Receives: Drug: Misoprostol ( Prostaglandin E2) |
| Foley's catheter | Experimental | In this group foley's catheter 30 cc will be used for induction of labor Receives: Device: Foley's catheter |
| Combined | Experimental | Both misoprostol 25 ug and foley's catheter will be used for induction Receives: Drug: Misoprostol ( Prostaglandin E2); Device: Foley's catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of induction of labor
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 posted18 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
- Investigators
- Dina MR Dakhly, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685085
- Sponsor's protocol ID
- FM0702116
- Status last verified
- Feb 2016
- First submitted
- 9 Feb 2016
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Method for Induction of Labor
- ClinicalTrials.gov ID
- NCT02685085
- Acronym / sponsor ID
- FM0702116
- Conditions
- Induced Labor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 18 Feb 2016 (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.
Induction of labor is performed via the vaginal misorostol 25 ug/ 6 hours and intracervical foley's cather administration and both techniques performed together.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: Misoprostol ( Prostaglandin E2)in this group misoprostol 25 ug will be administrated for induction of labor every 6 hours |
| Foley's catheter | Experimental | Device: Foley's catheterIn this group foley's catheter 30 cc will be used for induction of labor |
| Combined | Experimental | Drug: Misoprostol ( Prostaglandin E2), Device: Foley's catheterBoth misoprostol 25 ug and foley's catheter will be used for induction |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- females presenting for induction of labor
Key exclusion criteria (3 listed)
- previous cesarean section
- previous uterine scars e.g. myomectomy
- refusal to participate in the study
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 ( Prostaglandin E2)Also: Cytotec | Drug | Combined, Misoprostol |
| Foley's catheter | Device | Combined, Foley's catheter |
Primary outcome
Duration of induction of labor
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 18 Feb 2016.
- Individual participant dataSharing planned: Undecided
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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.
Dina MR Dakhly, MD principal investigator
Cairo 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 ( Prostaglandin E2) and Foley's catheter in people with Induced Labor, run by Woman's Health University Hospital, Egypt 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 3 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 18 Feb 2016. 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 Dina MR Dakhly, MD (01003498919 ext. 002, dinadakhly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of induction of labor (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 18 Feb 2016.