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

Status unconfirmed

Conditions studied: To Evaluate the Impact of the Vaginal Ph and Acidification of Vaginal Misoprostol on Its Efficacy in Facilitating Induction of Mid-trimester Abortion.

In brief

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

Key facts

Study ID

NCT01241045

Run by

Ain Shams University

People needed

100

Starts

2010-11-01

Expected to finish

2010-12-01

Last updated by the study team

2010-11-16

Who can join

Age: 15 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Inclusion Criteria:-
• 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.

You may not qualify if…

• Exclusion Criteria:-
• 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.
• 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.

Where it is running

• Ain Shams — Cairo, California, United States

Full record on ClinicalTrials.gov

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