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RESEARCH HYPOTHESIS
-Incidence of preterm delivery is lower in women treated with oral micronized progesterone (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side effect
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Utrogestan | Active Comparator | oral tablet Utrogestan 400mg daily for 2 days |
|
| Nifedipine | Placebo Comparator | tablet Nifedipine 20 mg stat then 20 mg after 30 minutes then another 20 mg after 30 minutes followed by 10 mg three times daily for 2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| utrogestan | Drug | Oral Tablet Utrogestan 400 mg daily for 2 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| latency period interval between time of tocolysis and delivery | delivery less than 24 hours of tocolysis,delivery less than 48 hours of tocolysis, delivery less than 7 days of tocolysis | 24 hours up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy outcomes | delivery less than 34 weeks of gestation, delivery more than or at 34 weeks of gestation | 34 weeks of gestational age |
| Neonatal outcome | Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission |
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Inclusion Criteria:
• Singleton pregnancy women between 22 and 34 weeks of gestation who presented with threatened preterm labor.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| nor zila hassan malek | Contact | 60139823219 | nzhm_dr@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| nor azlin mohamed ismail | National University of Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetric and Gynaecology Department, National University of Malaysia Medical Centre | Cheras | Kuala Lumpur | 56000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35947046 | Derived | Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2. |
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| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000624167 | Utrogestan |
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Nifedipine |
| Drug |
Tablet Nifedipine 20 mg stat then 20 mg after 30 minutes if contraction persist and another 20mg after 30 minutes if contraction still persist followed by 10 mg three times daily for 2 days |
|
| 24 hours |
| Maternal side effect | Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus | 30 minutes up to 48 hours |