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To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone for labor induction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Experimental | 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. |
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| Control | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misotac® Sigma Pharmaceutical Industries | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Induction delivery interval i.e. Time from start of medication till delivery | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patients delivered vaginally within the first 24 hours | 24 hours | |
| Time from start of labor augmentation by either misoprostol or Syntocinon (oxytocin) to active phase of labor | 12 hours | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amr H Yehia, MD, MRCOG | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Maternity Hospital - Ain Shams university | Recruiting | Cairo | Cairo Governorate | 11666 | Egypt |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Dinoprostone 3 mg | Drug | 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. |
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| Duration of 1st,2nd and 3rd stages of labor |
| 24 hours |
| Maternal complications | uterine hyperstimulation, postpartum hemorrhage, uterine rupture, sepsis, shivering, headache, nausea, vomiting, and retained placenta. | 24 hours |
| Mode of delivery | Vaginal , instrumental or Cesarean section | 24 hours |
| Neonatal outcome | Apgar score at 1 and 5 minutes and Neonatal Intensive Care Unit admission | 24 hours |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011458 | Prostaglandins E |