MISED ABORTION- Vaginal PHNCT01270334
Effect of Vaginal PH on Treatment Effectiveness With Misoprostol for First Trimester Missed Abortions
An observational study of MISED ABORTION- Vaginal PH, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
vaginal PH has an effect on the effectiveness of treatment with misoprostol given vaginally for missed abortions in the first trimester Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- MISED ABORTION- Vaginal PH
- What is being tested?
- PH meassurment
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to not given
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women dignosed with missed abortion in the first trimester
Who may be able to join
- missed abortion under 8 weeks by sac diameter over 18 years old informed concent given
Who cannot join
- missed abortion over 8 weeks hypersensitivity for PG vaginal bleeding suspected EUP IUD heart disease, HTN, cerebral vascular disease, epilepsy intrauterine infection clooting disorder under 18
Trial locations and contacts
1 site in 1 country.
Israel1 site
Haemel Medical Center
Afula
shira baram, md, 972-4-6494035
shira baram, md
About this study
vaginal PH has an effect on the effectiveness of treatment with misoprostol given vaginally for missed abortions in the first trimester
- Conditions
- MISED ABORTION- Vaginal PH
- Being tested
- PH meassurment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH meassurmentOther
meassuring ph USING PROBE
| Study group | Role | What they receive |
|---|---|---|
| ph above cutoff | Not described Receives: Other: PH meassurment | |
| PH under cutoff | Not described Receives: Other: PH meassurment |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment failure- need for D&C
Measured: 2 weeks
Secondary outcomes (1)
side effects, need foe analgetics, time for compliting abortion
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MISED ABORTION- Vaginal PHStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270334
- Sponsor's protocol ID
- cytoph
- Status last verified
- Jan 2011
- First submitted
- 4 Jan 2011
- Last updated
- 5 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vaginal PH on Treatment Effectiveness With Misoprostol for First Trimester Missed Abortions
- ClinicalTrials.gov ID
- NCT01270334
- Acronym / sponsor ID
- cytoph
- Conditions
- MISED ABORTION- Vaginal PH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Feb 2011
- First posted
- 5 Jan 2011 (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 PH has an effect on the effectiveness of treatment with misoprostol given vaginally for missed abortions in the first trimester
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ph above cutoff | – | Other: PH meassurment |
| PH under cutoff | – | Other: PH meassurment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women dignosed with missed abortion in the first trimester
Key inclusion criteria (1 listed)
- missed abortion under 8 weeks by sac diameter over 18 years old informed concent given
Key exclusion criteria (1 listed)
- missed abortion over 8 weeks hypersensitivity for PG vaginal bleeding suspected EUP IUD heart disease, HTN, cerebral vascular disease, epilepsy intrauterine infection clooting disorder under 18
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 |
|---|---|---|
| PH meassurmentmeassuring ph USING PROBE | Other | PH under cutoff, ph above cutoff |
Primary outcome
treatment failure- need for D&C
Time frame: 2 weeks
1 secondary outcome
side effects, need foe analgetics, time for compliting abortion
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2011.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MISED ABORTION- Vaginal PH, run by HaEmek Medical Center, Israel at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 5 Jan 2011. 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 Israel. 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 shira baram, dr (972-4-6494035, shira_ba@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment failure- need for D&C (time frame: 2 weeks). 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 5 Jan 2011.