Study of Effect of Vaginal ph and Acidification of Vaginal Misoprostol on Its Efficacy for Induction of Midtrimester Abortion
Recruitment status was: Not yet recruiting
To Evaluate the Impact of the Vaginal Ph and Acidification of Vaginal Misoprostol on Its Efficacy in Facilitating Induction of Mid-trimester Abortion.
|Study Design:||Observational Model: Ecologic or Community|
|Official Title:||EFFECT OF VAGINAL Ph AND ACIDIFICATION OF VAGINAL MISOPROSTOL ON ITS EFFICACY FOR INDUCTION OF MID-TRIMESTERIC ABORTION|
- induction-termination interval [ Time Frame: 11 hours ] [ Designated as safety issue: Yes ]time elapsed from admenstiration of drug to occurrence of abortion
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241045
|United States, California|
|Cairo, California, United States|