TheEffect of pH on Misoprostol in Induction of Labor

Aljazeera Hospital

Status: Unknown

Conditions: Labor Pain

Treatments: Drug: misoprostol in an acidic media; Drug: misoprostol in a neutral media; Drug: misoprostol in an alkaline media

Study type: Interventional

Funder types: Other

Identifiers

NCT03829592

Misoprostol

Details and patient eligibility

About

Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was initially marketed for the treatment of peptic ulcers due to its mucosal protective and anti-secretory properties, but has commonly been used for the induction of abortion and labour .

Full description

Although initially having been established for oral use, misoprostol tablets are commonly used as vaginal suppositories for the previously purposes. Water or saline are frequently used in common practice to moisten the tablets prior to their administration, however, according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium

Enrollment: 180 estimated patients

Sex: Female

Ages: 20 to 42 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation

Exclusion criteria

• 1. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups, including a placebo group

misoprostol in neutral media

Placebo Comparator group

Description:

Intervention : misoprostol in a neutral media will be given to women to induce labour

Treatment:

Drug: misoprostol in a neutral media

Misoprostol in acidic media

Active Comparator group

Description:

Intervention : misoprostol in acidic media will be given to induce labour

Treatment:

Drug: misoprostol in an acidic media

Misoprostol in alkaline media

Sham Comparator group

Description:

Intervention : misoprostol in alkaline media will be given to induce labour

Treatment:

Drug: misoprostol in an alkaline media