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This study compares safety and efficacy between repetitive hourly dose of oral misoprostol and two hourly dose oral regimens for cervical ripening and labor induction.
Misoprostol is an effective agent for the induction of labor.existing guidelines recommend oral misoprostol solution every two hours.However,more research is required to optimize the use of oral misoprostol solution for labor induction.The current study is to compare efficacy and safety of repetitive hourly dose of oral misoprostol solution with two hourly dose of oral misoprostol solution for cervical ripening and labor induction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| repetitive hourly dose of oral misoprostol | Experimental | The dose will be 10 microgram oral misoprostol that will be administered hourly up to 12 doses or till onset of regular uterine activity. |
|
| two hourly dose of oral misoprostol | Experimental | The dose will be 20 microgram oral misoprostol solution that will be administered every 2 hours up to 6 doses or till onset of regular uterine activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | This study will include 150 pregnant women who fulfill the inclusion criteria and will be subdivided in two groups. Group1 will receive repetitive hourly dose of oral misoprostol solution equal to 10 microgram up to 12 doses or regular uterine activity. Group2 will receive oral misoprostol solution every two hours as 20 microgram up to 6 doses or regular uterine activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Mode of delivery | Successful vaginal delivery within 24 hours from starting induction of labor or cesarean section delivery after failed trial of induction. | 24 hours from the first dose of induction till delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse maternal outcomes | As uterine hyper stimulation,fever,vomiting,shivering,nausea | in 24 hours |
| Adverse neonatal outcomes | As neonatal intensive care unit admission,non reassuring fetal heart rate |
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Inclusion Criteria:
Exclusion Criteria:
150 pregnant women who fulfill inclusion criteria.these will be subjected to history taking,physical examination,counseling and signing a written consent will be taken from each case.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| essam sa hagag, MBBCh | Contact | 01066813830 | essamhagag742@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| essam sa hagag, MBBCh | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | Cairo Governorate | 002 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 27986461 |
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De-identified individual participant data for all primary and secondary outcome measures will be available.
Data will be available within 6 months of study completion.
Data access requests will be reviewed by an external independent review panel.requestors will be required to sign a data access agreement.
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
| 24 hours post partum |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |