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The current study is a randomized, controlled, double-blinded trial of Obstetric Cook Catheter combined with oral misoprostol for induction of labor in pregnant patients. The primary outcome to be studied is vaginal delivery rate for the Obstetric Cook Catheter in combination with oral placebo and the Obstetric Cook Catheter in combination with oral misoprostol. Secondary outcomes to be studied include the safety of the method, composite maternal morbidity and composite neonatal morbidity.
The hypothesis is that there is a higher vaginal delivery rate in the patient whom receive both the Obstetric Cook Catheter and the oral misoprostol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cook Catheter, Oral Misoprostol | Experimental | Cook Catheter is placed and a 50mcg misoprostol tablet is given orally. A repeat dose is administered in 3 hours. |
|
| Cook Catheter, Oral Placebo | Placebo Comparator | Cook Catheter is placed and a placebo tablet is given orally. A repeat dose is administered in 3 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of cesarean section | Within 96 hours from the commencement of the Induction of Labor |
| Measure | Description | Time Frame |
|---|---|---|
| Time from start of induction of labor to vaginal delivery | 24, 48 and 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cervical bishop score with allotted treatment | 6 hours |
Inclusion Criteria:
Exclusion Criteria:
1. Fetal demise 2. Fetal malpresentation 3. Estimated fetal weight less than 500 grams or more than 4000 grams 4. Placenta previa 5. Non-reassuring fetal health assessment 6. Active maternal asthma exacerbation requiring additional medications from the usual medication requirements.
7. History of cesarean section 8. Rupture of amniotic membrane 9. Latex allergy 10. Spontaneous labor 11. Other contraindication to vaginal delivery 12. Allergy to misoprostol of cook catheter
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meg Hill, MBBS | Contact | 520 626 6174 | meg.hill@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Meg Hill, MBBS | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Tucson | Arizona | 85718 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996264 | Derived | de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 27, 2017 | |
| Reset | Dec 27, 2017 | |
| Release | Jan 2, 2018 | |
| Reset | Jan 29, 2018 | |
| Release | Apr 3, 2018 | |
| Reset | May 3, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 27, 2017 | Dec 27, 2017 | |||
| Jan 2, 2018 |
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Other |
|
| Jan 29, 2018 |
| Apr 3, 2018 | May 3, 2018 |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |