Failed Induction of LaborPhase 3NCT01506388
A Novel Protocol for Labour Induction
A Phase 3 study testing foley catheter, Misoprostol and Vaginal IMN in people with Failed Induction of Labor, run by Cairo University at 2 sites in Egypt.
Trial summary
The use of foley catheter was tested many times and proved to be effective for induction of labour. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Failed Induction of Labor
- What is being tested?
- foley catheter, Misoprostol and Vaginal IMN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesEgypt
- Study dates
- Feb 2012to Jan 2014
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Term or post term pregnancies.
- Live,singleton fetus.
- Cephalic presentation.
- Intact membrane.
- Bishop score < 6.
- Not in labour.
- Medically indicated for labour induction.
- Primigravida or parity of 3 or less.
Who cannot join
- Previous caesarean delivery.
- Malpresentation.
- Placenta previa.
- Sever intrauterine growth restriction.
- Multiple pregnancy.
- Polyhydramnios.
- Oligohydramnios.
- Bishop score 7 or more.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo University
Cairo, Cairo Governorate, 12211
Waleed El-khayat
Cairo, Cairo Governorate, 12211
About this study
Official title: Foley Catheter Plus Vaginal Isosorbide Mononitrate Versus Vaginal Misoprostol for Induction of Labour:a Randomised Controlled Trial
The use of foley catheter was tested many times and proved to be effective for induction of labour.
Read the detailed description
The investigators compare between vaginal misoprostol versus foley catheter plus vaginal isosorbide mononitrate (IMN) for induction of labour
- Conditions
- Failed Induction of Labor
- Being tested
- foley catheter, Misoprostol, Vaginal IMN
- Keywords
- labour induction, Foley catheter, misoprostol, isosorbide mononitrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foley catheterDevice
foley 14 catheter intracervical plus vaginal IMN 40 mg evry 6 hours
MisoprostolDrug
Also called misoprostol vaginally
misoprostol 50 Ug , vaginally every 4-6 hours
Vaginal IMNDrug
IMN vaginal 40 mg every 4-6 hours
| Study group | Role | What they receive |
|---|---|---|
| folye catheter plus vaginal IMN | Experimental | intracervical foley catheter plus vaginal IMN Receives: Device: foley catheter; Drug: Vaginal IMN |
| Misoprostol vaginally | Active comparator | intravaginal misoprostol Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
caesarean section rate
caesarean section
Measured: 1 year
Secondary outcomes (1)
time from induction to delivery
from the insertion of the foley catheter to delivery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Failed Induction of LaborStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-khayat, Cairo University
- Investigators
- Waleed El-khayat, M.D., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506388
- Sponsor's protocol ID
- 12012
- Status last verified
- Jan 2014
- First submitted
- 4 Jan 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264El-Khayat W, Alelaiw H, El-kateb A, Elsemary A. Comparing vaginal misoprostol versus Foley catheter plus vaginal isosorbide mononitrate for labor induction. J Matern Fetal Neonatal Med. 2016;29(3):487-92. doi: 10.3109/14767058.2015.1007036. Epub 2015 Feb 19.
PubMed 25694257
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foley Catheter Plus Vaginal Isosorbide Mononitrate Versus Vaginal Misoprostol for Induction of Labour:a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01506388
- Acronym / sponsor ID
- 12012
- Conditions
- Failed Induction of Labor
- Keywords
- labour induction, Foley catheter, misoprostol, isosorbide mononitrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Jan 2012 (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.
The use of foley catheter was tested many times and proved to be effective for induction of labour.
Detailed description
The investigators compare between vaginal misoprostol versus foley catheter plus vaginal isosorbide mononitrate (IMN) for induction of labour
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| folye catheter plus vaginal IMN | Experimental | Device: foley catheter, Drug: Vaginal IMNintracervical foley catheter plus vaginal IMN |
| Misoprostol vaginally | Active comparator | Drug: Misoprostolintravaginal misoprostol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Term or post term pregnancies.
- Live,singleton fetus.
- Cephalic presentation.
- Intact membrane.
- Bishop score < 6.
Key exclusion criteria (8 listed)
- Previous caesarean delivery.
- Malpresentation.
- Placenta previa.
- Sever intrauterine growth restriction.
- 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 |
|---|---|---|
| foley catheterfoley 14 catheter intracervical plus vaginal IMN 40 mg evry 6 hours | Device | folye catheter plus vaginal IMN |
| MisoprostolAlso: misoprostol vaginallymisoprostol 50 Ug , vaginally every 4-6 hours | Drug | Misoprostol vaginally |
| Vaginal IMNIMN vaginal 40 mg every 4-6 hours | Drug | folye catheter plus vaginal IMN |
Primary outcome
caesarean section rate
Time frame: 1 year
caesarean section
1 secondary outcome
time from induction to delivery
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Derived from this study: PubMed 25694257El-Khayat W, Alelaiw H, El-kateb A, Elsemary A. Comparing vaginal misoprostol versus Foley catheter plus vaginal isosorbide mononitrate for labor induction. J Matern Fetal Neonatal Med. 2016;29(3):487-92. doi: 10.3109/14767058.2015.1007036. Epub 2015 Feb 19.
Related trials for Failed Induction of Labor
Recruiting
Oxytocin Rest to Reduce Cesarean Delivery
Prolonged Labor, Failed Induction
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.
Waleed El-khayat, M.D. study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing foley catheter, Misoprostol and Vaginal IMN in people with Failed Induction of Labor, run by Cairo University at 2 sites 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 8 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: finished, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caesarean section rate (time frame: 1 year). 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 NCT01506388, which also lists 2 linked publications.
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 22 Jan 2014.