Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor

Ain Shams University

Status and phase: Unknown; Phase 3

Conditions: Medical Induction of Labor Affecting Fetus

Treatments: Drug: Dinoprostone 3 mg; Drug: Misotac® Sigma Pharmaceutical Industries

Study type: Interventional

Funder types: Other

Identifiers

NCT02036437

elkont1984

Details and patient eligibility

About

To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone for labor induction.

Full description

• There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common indication. It is well recognized that with an unripe cervix, induction may be difficult and often unsuccessful. The use of an agent to ripen the cervix prior to induction is acceptable in the modern practice.
• Misoprostol, a prostaglandin E1 analogue, is the most interesting alternative to Dinoprostone because of its effectiveness, low cost, and temperature stability. It ripens the cervix by inducing regular uterine contractions. However, it is associated with several adverse effects especially uterine hyperstimulation, which is painful and may result in fetal compromise.
• Testing the efficacy and safety of titrated oral misoprostol versus vaginal dinoprostone may develop a new safe and effective method for labor induction.

Enrollment: 200 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Single vertex presentation.
• Gestational age > 37 weeks calculated from last menstrual period or U/S scanning.
• Bishop score <8 .
• Not in labor.
• Reassuring fetal heart rate (CTG for 20 min on the day of induction).
• Valid indication for Induction of labor.

Exclusion criteria

• Gestational age <37 weeks.
• Patients with rupture of membranes.
• Previous uterine scar.
• Fetal malpresentation.
• Multiple pregnancy.
• Significant antepartum hemorrhage
• Uncontrolled DM.
• Severe Pre-eclampsia or Eclampsia
• If there are contraindications to receive the drugs, e.g. allergy, history of severe asthma,.....etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Cases

Experimental group

Description:

A dose of 20ug is required obtained by dissolving the 200ug tablet (Misotac® Sigma Pharmaceutical Industries) in 200 ml water (1ug per ml), the solution is shaked well before each administration. The solution will be orally administrated every two hours (max. 12 hrs) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose will be increased to 40 ml (40ug) after two doses if there are no contractions. The timing and strength of contractions will be assessed by abdominal palpation. If the contractions are inadequate, augmentation of the active phase of labor will be attempted by hourly-titrated oral misoprostol (20 ml) +/- amniotomy.

Treatment:

Drug: Misotac® Sigma Pharmaceutical Industries

Control

Active Comparator group

Description:

Dinoprostone 3 mg (Dinoglandin® Alexandria Co. for Pharmaceuticals) will be inserted in the posterior vaginal fornix and repeated after six hours if contractions are inadequate (i.e. two doses maximum). If the contractions become inadequate, augmentation of the active phase of labor will be attempted by Syntocinon (oxytocin) infusion +/- amniotomy.

Treatment:

Drug: Dinoprostone 3 mg