Induction of Labor Affected Fetus / NewbornPhase 2NCT02952807
Vaginal Misoprostol and Foley Catheter for Induction of Labor
A Phase 2 study testing Misoprostol and Foley Catheter in people with Induction of Labor Affected Fetus / Newborn, run by Zagazig University at 1 site in Egypt.
Trial summary
to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor 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
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Misoprostol and Foley Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Feb 2017
- 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
- Indication for labour induction Term pregnancy with alive fetus Bishop score less than five
Who cannot join
- Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors, malformations and/or ulcers of vulva, perineum or vagina
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sequential Versus Concurrent Use of Vaginal Misoprostol Plus Foley Catheter for Induction of Labor
to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor
Read the detailed description
two groups of patients who are eligible for labor induction were randomized to either sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal misopristol plus foleys catheter.
- Being tested
- Misoprostol, Foley Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called cytotec
vaginal Misoprostol Plus Foley Catheter
Foley CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| sequential | Active comparator | sequential use of vaginal misoprotol Plus Foley Catheter for Induction of Labor. Receives: Drug: Misoprostol; Device: Foley Catheter |
| Concurrent | Active comparator | Concurrent Use of Vaginal misoprostol Plus Foley Catheter for Induction of Labor. Receives: Drug: Misoprostol; Device: Foley Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction delivery interval (time from starting induction to delivery)
safety issue
Measured: 48hours
Secondary outcomes (7)
Need of oxytocin for augmentation of labour
safety issue
Measured: 48h
Number of doses needed to bring on labour
safety issue
Measured: 48h
Failed induction (failure to elicit contraction after 72 hours)
safety issue
Measured: 72h
Hyperstimulation syndrome
safety issue
Measured: 24h
Cesarean section
safety issue
Measured: 72h
Severe neonatal morbidity or perinatal death
safety issue
Measured: 28 days
Serious maternal morbidity or maternal death
safety issue
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionFeb 2017
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 Induction of Labor Affected Fetus / NewbornStudies of the same condition, open and under way.
- More trials run by Zagazig 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, IBRAHIM ABD ELGAFOR, Zagazig University
- Investigators
- ibrahim A el sharkwy, MD, Principal investigator, FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952807
- Sponsor's protocol ID
- 2
- Status last verified
- Nov 2016
- First submitted
- 31 Oct 2016
- Last updated
- 16 Jun 2017
- 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 36996264
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Versus Concurrent Use of Vaginal Misoprostol Plus Foley Catheter for Induction of Labor
- ClinicalTrials.gov ID
- NCT02952807
- Acronym / sponsor ID
- 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 2 Nov 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.
to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor
Detailed description
two groups of patients who are eligible for labor induction were randomized to either sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal misopristol plus foleys catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequential | Active comparator | Drug: Misoprostol, Device: Foley Cathetersequential use of vaginal misoprotol Plus Foley Catheter for Induction of Labor. |
| Concurrent | Active comparator | Drug: Misoprostol, Device: Foley CatheterConcurrent Use of Vaginal misoprostol Plus Foley Catheter for Induction of Labor. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Indication for labour induction Term pregnancy with alive fetus Bishop score less than five
Key exclusion criteria (1 listed)
- Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors, malformations and/or ulcers of vulva, perineum or vagina
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 |
|---|---|---|
| MisoprostolAlso: cytotecvaginal Misoprostol Plus Foley Catheter | Drug | Concurrent, sequential |
| Foley Catheter | Device | Concurrent, sequential |
Primary outcome
induction delivery interval (time from starting induction to delivery)
Time frame: 48hours
safety issue
7 secondary outcomes
Need of oxytocin for augmentation of labour
Time frame: 48h
Number of doses needed to bring on labour
Time frame: 48h
Failed induction (failure to elicit contraction after 72 hours)
Time frame: 72h
Hyperstimulation syndrome
Time frame: 24h
Cesarean section
Time frame: 72h
Severe neonatal morbidity or perinatal death
Time frame: 28 days
Serious maternal morbidity or maternal death
Time frame: 42 days
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 16 Jun 2017.
- 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.
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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.
ibrahim A el sharkwy, MD principal investigator
FACULTY OF MEDICINE ,ZAGAZIG 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 and Foley Catheter in people with Induction of Labor Affected Fetus / Newborn, run by Zagazig 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 1 inclusion and 1 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 16 Jun 2017. 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?
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?
induction delivery interval (time from starting induction to delivery) (time frame: 48hours). 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 NCT02952807, 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 16 Jun 2017.