To Evaluate the Impact of the Vaginal Ph and Acidification of Vaginal Misoprostol on Its Efficacy in Facilitating Induction of Mid-trimester Abortion.NCT01241045
Study of Effect of Vaginal ph and Acidification of Vaginal Misoprostol on Its Efficacy for Induction of Midtrimester Abortion
An observational study of To Evaluate the Impact of the Vaginal Ph and Acidification of Vaginal Misoprostol on Its Efficacy in Facilitating Induction of Mid-trimester Abortion., run by Ain Shams University at 1 site in United States.
Trial summary
To evaluate the impact of the vaginal Ph and acidification of vaginal misoprostol on its efficacy in facilitating induction of midtrimester abortion. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- To Evaluate the Impact of the Vaginal Ph and Acidification of Vaginal Misoprostol on Its Efficacy in Facilitating Induction of Mid-trimester Abortion.
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2010
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: community sample
Who may be able to join
- Age 18-45 years.
- A valid indication for termination of pregnancy.
- Singleton pregnancy.
- Gestational age ranging between 14 and 26 weeks of pregnancy.
- Uterus and cervix are apparently normal on clinical examination.
- Cervix is not dilated with absence of effacement.
- Absence of uterine activity.
- Written and signed informed consent by the patient to participate in the study.
Who cannot join
- A contraindication to medical termination of pregnancy e.g. placenta praevia.
- Evidences suggesting onset of spontaneous abortion (uterine contractions with or without cervical changes).
- Previous trial to induce abortion or the use of pre-induction agent during the current pregnancy.
- Any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs), history of asthma, glaucoma, cardiac or cardiovascular disease.
- Parity six or more.
- Multifetal pregnancy.
Show all 14Show fewer
- Severe Polyhydramnios.
- Presence of vaginal bleeding.
- Presence of ruptured membranes and/or suspicion of septic abortion as evidenced by maternal temperature of 38°C or more, uterine tenderness or foul-smelling vaginal discharge.
- Previous Caesarean section or other uterine surgery or perforation.
- Cervical cerclage during current pregnancy, or history of it during a previous pregnancy.
- Previous cervical surgery as cauterization of cervical erosion or cervical dilatation operation with resultant apparent cervical tears or lacerations.
- Metabolic acidosis as a result of a medical disorder.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol which include all vaginal forms of medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF VAGINAL Ph AND ACIDIFICATION OF VAGINAL MISOPROSTOL ON ITS EFFICACY FOR INDUCTION OF MID-TRIMESTERIC ABORTION
To evaluate the impact of the vaginal Ph and acidification of vaginal misoprostol on its efficacy in facilitating induction of midtrimester abortion.
Read the detailed description
100 Pregnant women, in mid-trimester, with a medical indication for termination of pregnancy will be approached to participate in this study Methods:-
- A formal consent from the women under study with full notification and explanation of the methods, importance of the study and possible unwanted effects.
- During the pre-selection visit, exclusion and inclusion criteria will be applied. Baseline investigations; Blood sugar, Serum Glutamate Oxaloacetate Transaminase (SGOT), Serum Glutamate Pyruvate Transaminase (SGPT), S. Creatinine, and Complete Blood Count (C.B.C.) and Coagulation profile (PTT, serum fibrinogen level) will be done.
- Following admission, all patients will undergo complete clinical examination and detailed medical history will be obtained. Each patient will have a Case Record Form (CRF) in which the following data will be recorded.
- Patient initials.
- Patient number (according to the randomization schedule).
- Age, height, weight,
- Known allergies.
- Past medical and surgical history (no longer present).
- Medications taken within the last 4 weeks and discontinued.
- Concomitant illnesses.
- Concomitant medications which will not be discontinued.
- Clinical examination: including full gynaecologic assessment including vaginal and speculum examination with recording of vaginal and cervical condition.
- The vaginal Ph will be measured using Universal indicator paper pH (1-14) before digital vaginal examination. Through speculum examination, the indicator will be held with an artery forceps against the vaginal wall-high up in the vagina-until it becomes wet. Color change of the strip will be immediately compared with the colorimetric scale and the measurement will be recorded. Patients will be divided into 2 groups:-
- Group 1:-those with Ph<5. (n=50).
- Group 2:-those with Ph > or=5. (n=50).
- Each group is subdivided into another two groups:-
- Group 1A (n=25). - Group 1B (n=25).
- Group 2A (n=25). - Group 2B (n=25).
- All the women in group 1A and group 2A will receive intravaginal misoprostol tablets moistened with 3 ml of 5% acetic acid, and all the women in group 1B and group 2B will receive intravaginal misoprostol tablets moistened with water, 400 micrograms every 4 hours for a maximum of 5 doses within 24 hours. If the patient will not have adequate uterine contractions, the same regimen will be repeated over the following 24 hours, and if no response will be achieved, this will be considered a failure of therapy, and another method will be used like large doses of oxytocin or cervical dilatation by foley's catheter no.16.
- assessment will be though the occurrence of uterine contraction and progress of abortion with induction -termination interval as a primary outcome.
- The investigator will supervise application of the medication dose by dose. Subjects withdrawn from the study before the onset of spontaneous labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| misoprostol | 2 groups:- * Group 1:-those with Ph<5. (n=50). * Group 2:-those with Ph > or=5. (n=50). -Each group is subdivided into another two groups:- * Group 1A (n=25). - Group 1B (n=25). * Group 2A (n=25). - Group 2B (n=25). * All the women in group 1A and group 2A will receive intravaginal misoprostol tablets moistened with 3 ml of 5% acetic acid, and all the women in group 1B and group 2B will receive intravaginal misoprostol tablets moistened with water, 400 micrograms every 4 hours for a maximum of 5 doses within 24 hours. If the patient will not have adequate uterine contractions, the same regimen will be repeated over the following 24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction-termination interval
time elapsed from admenstiration of drug to occurrence of abortion
Measured: 11 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Impact of the Vaginal Ph and Acidification of Vaginal Misoprostol on Its Efficacy in Facilitating Induction of Mid-trimester Abortion.Studies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Ecologic or community
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241045
- Sponsor's protocol ID
- AubshamsU
- Status last verified
- Nov 2010
- First submitted
- 15 Nov 2010
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF VAGINAL Ph AND ACIDIFICATION OF VAGINAL MISOPROSTOL ON ITS EFFICACY FOR INDUCTION OF MID-TRIMESTERIC ABORTION
- ClinicalTrials.gov ID
- NCT01241045
- Acronym / sponsor ID
- AubshamsU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 16 Nov 2010 (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 evaluate the impact of the vaginal Ph and acidification of vaginal misoprostol on its efficacy in facilitating induction of midtrimester abortion.
Detailed description
100 Pregnant women, in mid-trimester, with a medical indication for termination of pregnancy will be approached to participate in this study Methods:-
- A formal consent from the women under study with full notification and explanation of the methods, importance of the study and possible unwanted effects.
- During the pre-selection visit, exclusion and inclusion criteria will be applied. Baseline investigations; Blood sugar, Serum Glutamate Oxaloacetate Transaminase (SGOT), Serum Glutamate Pyruvate Transaminase (SGPT), S. Creatinine, and Complete Blood Count (C.B.C.) and Coagulation profile (PTT, serum fibrinogen level) will be done.
- Following admission, all patients will undergo complete clinical examination and detailed medical history will be obtained. Each patient will have a Case Record Form (CRF) in which the following data will be recorded.
- Patient initials.
- Patient number (according to the randomization schedule).
- Age, height, weight,
- Known allergies.
- Past medical and surgical history (no longer present).
- Medications taken within the last 4 weeks and discontinued.
- Concomitant illnesses.
- Concomitant medications which will not be discontinued.
- Clinical examination: including full gynaecologic assessment including vaginal and speculum examination with recording of vaginal and cervical condition.
- The vaginal Ph will be measured using Universal indicator paper pH (1-14) before digital vaginal examination. Through speculum examination, the indicator will be held with an artery forceps against the vaginal wall-high up in the vagina-until it becomes wet. Color change of the strip will be immediately compared with the colorimetric scale and the measurement will be recorded. Patients will be divided into 2 groups:-
- Group 1:-those with Ph<5. (n=50).
- Group 2:-those with Ph > or=5. (n=50).
- Each group is subdivided into another two groups:-
- Group 1A (n=25). - Group 1B (n=25).
- Group 2A (n=25). - Group 2B (n=25).
- All the women in group 1A and group 2A will receive intravaginal misoprostol tablets moistened with 3 ml of 5% acetic acid, and all the women in group 1B and group 2B will receive intravaginal misoprostol tablets moistened with water, 400 micrograms every 4 hours for a maximum of 5 doses within 24 hours. If the patient will not have adequate uterine contractions, the same regimen will be repeated over the following 24 hours, and if no response will be achieved, this will be considered a failure of therapy, and another method will be used like large doses of oxytocin or cervical dilatation by foley's catheter no.16.
- assessment will be though the occurrence of uterine contraction and progress of abortion with induction -termination interval as a primary outcome.
- The investigator will supervise application of the medication dose by dose. Subjects withdrawn from the study before the onset of spontaneous labor
Study design
- Observational model
- Ecologic or community
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| misoprostol | – | –2 groups:- * Group 1:-those with Ph<5. (n=50). * Group 2:-those with Ph > or=5. (n=50). -Each group is subdivided into another two groups:- * Group 1A (n=25). - Group 1B (n=25). * Group 2A (n=25). - Group 2B (n=25). * All the women in group 1A and group 2A will receive intravaginal misoprostol tablets moistened with 3 ml of 5% acetic acid, and all the women in group 1B and group 2B will receive intravaginal misoprostol tablets moistened with water, 400 micrograms every 4 hours for a maximum of 5 doses within 24 hours. If the patient will not have adequate uterine contractions, the same regimen will be repeated over the following 24 hours |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- community sample
Key inclusion criteria (8 listed)
Key exclusion criteria (14 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
induction-termination interval
Time frame: 11 hours
time elapsed from admenstiration of drug to occurrence of abortion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 To Evaluate the Impact of the Vaginal Ph and Acidification of Vaginal Misoprostol on Its Efficacy in Facilitating Induction of Mid-trimester Abortion., run by Ain Shams University at 1 site in United States.
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 14 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 16 Nov 2010. 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 United States. 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?
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-termination interval (time frame: 11 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 16 Nov 2010; AzTrials last refreshed its copy on 8 Nov 2026.