An observational study in To Evaluate the Impact of the Vaginal Ph and Acidification of Vaginal Misoprostol on Its Efficacy in Facilitating Induction of Mid-trimester Abortion., sponsored by Ain Shams University. Status unknown at 1 site in United States. Open to female participants aged 15 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-16.
Sponsored by Ain Shams University · Observational
To evaluate the impact of the vaginal Ph and acidification of vaginal misoprostol on its efficacy in facilitating induction of midtrimester abortion.
100 Pregnant women, in mid-trimester, with a medical indication for termination of pregnancy will be approached to participate in this study Methods:-
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.
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:-
Each group is subdivided into another two groups:-
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
community sample
Inclusion Criteria:-
Exclusion Criteria:
Exclusion Criteria:-
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
induction-termination interval
time elapsed from admenstiration of drug to occurrence of abortion
Time frame: 11 hours
This study is status unknown, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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Ain Shams University