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| Name | Class |
|---|---|
| North West Armed Forces Hospital | UNKNOWN |
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The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).
A controlled release hydrophilic matrix (Controlled Therapeutics Ltd., East Kilbride, Scotland) which provides a gradual release of dinoprostone (prostaglandin E2) was introduced in 1995 (Propess, Ferring Pharmaceuticals). This preparation is used for the initiation or enhancement of cervical ripening in women at or after term with a singleton pregnancy and a cephalic presentation. Prostaglandin E2 causes softening and dilatation of the cervix and subsequently produces uterine contractions which may induce labour.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propess | Active Comparator | Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h. |
|
| Prostin E2 | Active Comparator | PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propess | Drug | The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour, the rupture of the membranes, or at the occurrence of hyperstimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Induction to Delivery Interval | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Induction to Onset of Labor Interval | 24 hours | |
| Uterine Hyper-stimulation Rate | 24 hours | |
| Need for Syntocinon Augmentation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Abdelaziz, M.D. | North West Armed Forces Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NWAFH, North west Armed Forces Hospital | Tabuk | Tabuk Region | Box 100 Tabuk | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30122579 | Derived | Abdelaziz A, Mahmoud AA, Ellaithy MI, Abees SH. Pre-induction cervical ripening using two different dinoprostone vaginal preparations: A randomized clinical trial of tablets and slow release retrievable insert. Taiwan J Obstet Gynecol. 2018 Aug;57(4):560-566. doi: 10.1016/j.tjog.2018.06.016. |
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Among the 228 women who met the eligibility criteria, 7 went into spontaneous labor and 4 had pathological Cardiotocography (CTG), so were excluded from being assigned to one of the treatment groups. After allocation 17 women were excluded from the analysis (15 refused to continue the induction of labor and had 5 incomplete records).
290 women were assessed for eligibility, 62 women were excluded (35 did not meet the inclusion criteria, 21 declined to participate and 6 refused induction of labor as a method of delivery)
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| ID | Title | Description |
|---|---|---|
| FG000 | Propess | Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h. |
| FG001 | Prostin E2 | PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propess | Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h. |
| BG001 | Prostin E2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Induction to Delivery Interval | Posted | Mean | Standard Deviation | hours | 24 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propess | Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cord pH < 7.1 | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maternal adverse outcomes | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Abdelaziz | NWAFH | 0096644411088 | webmaster@nwafh.med.sa |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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|
| Prostin E2 | Drug | 3 mg tab is placed in the posterior vaginal fornix. dose can be repeated every 6 hours till onset of active labour, the rupture of the membranes, or the occurrence of hyper-stimulation. |
|
|
| 24 hours |
| Normal Vaginal Delivery Rate | 24 hours |
PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Parity | Parity is the number times a woman has given birth to a fetus with a gestational age of 24 weeks or more, regardless of whether the child was born alive or was stillborn. (e.g., P3 is 3 births), a multiple birth considered as a single parous experience | Number | participants |
|
| Gestational age | For the purpose of pregnancy dating, Gestational age refers to the pregnancy duration in weeks calculated from the date of the last menstrual period. | Mean | Standard Deviation | weeks |
|
| Participants |
|
|
| Secondary | Induction to Onset of Labor Interval | Posted | Mean | Standard Deviation | hours | 24 hours |
|
|
|
| Secondary | Uterine Hyper-stimulation Rate | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | Need for Syntocinon Augmentation | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | Normal Vaginal Delivery Rate | Posted | Number | participants | 24 hours |
|
|
|
| 1 |
| 100 |
| 14 |
| 100 |
| EG001 | Prostin E2 | PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository. | 2 | 100 | 13 | 100 |
| Apgar score < 7 | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Uterine tachysystole | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |