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Study of Effect of Vaginal ph and Acidification of Vaginal Misoprostol on Its Efficacy for Induction of Midtrimester Abortion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Ain Shams University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ain Shams University
ClinicalTrials.gov Identifier:
NCT01241045
First received: November 15, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

To evaluate the impact of the vaginal Ph and acidification of vaginal misoprostol on its efficacy in facilitating induction of midtrimester abortion.


Condition Phase
To Evaluate the Impact of the Vaginal Ph and Acidification of Vaginal Misoprostol on Its Efficacy in Facilitating Induction of Mid-trimester Abortion.
Phase 4

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • induction-termination interval [ Time Frame: 11 hours ] [ Designated as safety issue: Yes ]
    time elapsed from admenstiration of drug to occurrence of abortion


Estimated Enrollment: 100
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)
Groups/Cohorts
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

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:-

  1. A formal consent from the women under study with full notification and explanation of the methods, importance of the study and possible unwanted effects.
  2. 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.
  3. 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.
  4. 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).
  5. Each group is subdivided into another two groups:-

    • Group 1A (n=25). - Group 1B (n=25).
    • Group 2A (n=25). - Group 2B (n=25).
  6. 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.
  7. assessment will be though the occurrence of uterine contraction and progress of abortion with induction -termination interval as a primary outcome.
  8. The investigator will supervise application of the medication dose by dose. Subjects withdrawn from the study before the onset of spontaneous labor
  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

Inclusion Criteria:

  • Inclusion Criteria:-

    1. Age 18-45 years.
    2. A valid indication for termination of pregnancy.
    3. Singleton pregnancy.
    4. Gestational age ranging between 14 and 26 weeks of pregnancy.
    5. Uterus and cervix are apparently normal on clinical examination.
    6. Cervix is not dilated with absence of effacement.
    7. Absence of uterine activity.
    8. Written and signed informed consent by the patient to participate in the study.

Exclusion Criteria:

  • Exclusion Criteria:-

    1. A contraindication to medical termination of pregnancy e.g. placenta praevia.
    2. Evidences suggesting onset of spontaneous abortion (uterine contractions with or without cervical changes).
    3. Previous trial to induce abortion or the use of pre-induction agent during the current pregnancy.
    4. Any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs), history of asthma, glaucoma, cardiac or cardiovascular disease.
    5. Parity six or more.
    6. Multifetal pregnancy.
    7. Severe Polyhydramnios.
    8. Presence of vaginal bleeding.
    9. 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.
    10. Previous Caesarean section or other uterine surgery or perforation.
    11. Cervical cerclage during current pregnancy, or history of it during a previous pregnancy.
    12. Previous cervical surgery as cauterization of cervical erosion or cervical dilatation operation with resultant apparent cervical tears or lacerations.
    13. Metabolic acidosis as a result of a medical disorder.
    14. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol which include all vaginal forms of medications.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241045

Locations
United States, California
Ain Shams Active, not recruiting
Cairo, California, United States
Sponsors and Collaborators
Ain Shams University
  More Information

No publications provided

Responsible Party: Ain Shams University
ClinicalTrials.gov Identifier: NCT01241045     History of Changes
Other Study ID Numbers: AubshamsU
Study First Received: November 15, 2010
Last Updated: November 15, 2010
Health Authority: Egypt: Ministry of Health, Drug Policy and Planning Center
United States: Food and Drug Administration

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014