Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor

Medical Induction of Labor Affecting Fetus Clinical Trial

Official title:

Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor: a Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02036437
• Other study ID #: elkont1984
• Status: Recruiting
• Phase: Phase 3
• First received: January 13, 2014
• Last updated: February 17, 2014
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2014
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medical Induction of Labor Affecting Fetus

Intervention

Drug:
• Misotac® Sigma Pharmaceutical Industries
The solution will be orally administrated every two hours (maximum 12 hours) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose of 20 ml (20 ug) 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. If the uterine contractions are judged to be adequate, the next dose of misoprostol will be omitted.
• Dinoprostone 3 mg
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.

Locations

Country	Name	City	State
Egypt	New Maternity Hospital - Ain Shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction delivery interval i.e. Time from start of medication till delivery		24 hours	Yes
Secondary	Patients delivered vaginally within the first 24 hours		24 hours	Yes
Secondary	Time from start of labor augmentation by either misoprostol or Syntocinon (oxytocin) to active phase of labor		12 hours	Yes
Secondary	Duration of 1st,2nd and 3rd stages of labor		24 hours	Yes
Secondary	Maternal complications	uterine hyperstimulation, postpartum hemorrhage, uterine rupture, sepsis, shivering, headache, nausea, vomiting, and retained placenta.	24 hours	Yes
Secondary	Mode of delivery	Vaginal , instrumental or Cesarean section	24 hours	Yes
Secondary	Neonatal outcome	Apgar score at 1 and 5 minutes and Neonatal Intensive Care Unit admission	24 hours	Yes