Late Second Trimester Termination of PregnancyPhase 2NCT02989324
Vaginal Misoprostol and Foley Catheter for Late Second Trimester Termination of Pregnancy
A Phase 2 study testing MisoprostoL and Foley Catheter in people with Late Second Trimester Termination of Pregnancy, run by Zagazig University at 1 site in Egypt.
Trial summary
Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections 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
- Late Second Trimester Termination of Pregnancy
- 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
- 97 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Nov 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
- IUFD
- Previous Multiple Cesarean Sections
Who cannot join
- asthma
- allergy to misoprostol
- patient refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Vaginal Misoprostol With or Without Foley Catheter for Late Second Trimester Pregnancy Termination in Women With Previous Multiple Cesarean Sections
Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections
Read the detailed description
this study aims to compare between Vaginal Misoprostol and Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections to assess safety and efficacy of theses methods.
- 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
Foley CatheterDevice
Misoprostol Plus Foley Catheter
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Misoprosto | Experimental | Vaginal Misoprosto for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Section Receives: Drug: MisoprostoL |
| Misoprostol Plus Foley Catheter | Active comparator | Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections Receives: Drug: MisoprostoL; Device: Foley Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction to expulsion interval
from time to start induction to time of complete expulsion of product of conception
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 posted12 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Second Trimester Termination of PregnancyStudies 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
- 97 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
- NCT02989324
- Sponsor's protocol ID
- zuh- 4
- Status last verified
- Nov 2016
- First submitted
- 30 Nov 2016
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Vaginal Misoprostol With or Without Foley Catheter for Late Second Trimester Pregnancy Termination in Women With Previous Multiple Cesarean Sections
- ClinicalTrials.gov ID
- NCT02989324
- Acronym / sponsor ID
- zuh- 4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 12 Dec 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.
Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections
Detailed description
this study aims to compare between Vaginal Misoprostol and Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections to assess safety and efficacy of theses methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Misoprosto | Experimental | Drug: MisoprostoLVaginal Misoprosto for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Section |
| Misoprostol Plus Foley Catheter | Active comparator | Drug: MisoprostoL, Device: Foley CatheterMisoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- IUFD
- Previous Multiple Cesarean Sections
Key exclusion criteria (3 listed)
- asthma
- allergy to misoprostol
- patient refuse to participate
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 | Drug | Misoprostol Plus Foley Catheter, Vaginal Misoprosto |
| Foley CatheterMisoprostol Plus Foley Catheter | Device | Misoprostol Plus Foley Catheter |
Primary outcome
induction to expulsion interval
Time frame: 24 hours
from time to start induction to time of complete expulsion of product of conception
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 7 Feb 2018.
- Individual participant dataSharing planned: No
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 Late Second Trimester Termination of Pregnancy, 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 2 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: finished, as of the sponsor's last update on 7 Feb 2018. 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 to expulsion interval (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 7 Feb 2018.