Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dr. Ahmed S. Abd El-Hameed | UNKNOWN |
| Prof. Abdel-Megeeed I. Abdel- Megeeed | UNKNOWN |
Not provided
Not provided
Not provided
This study aims to establish the efficacy of transdermal glyceryl trinitrate as a nitric oxide donor in addition to dinoprostone for induction of cervical ripening in the third trimester through progression in the Bishop's score during 24 hour period.
Objectives: The primary outcome of the study is to compare the changes occurring to the cervix through the progression in the Bishop's score between NO donor (nitroglycerine patch) vs placebo; in combination with a well-established method of induction (Dinoprostone).
The secondary objective of the study is to observe and report possible fetal and maternal side effects that may be associated. This will establish the safety and tolerability of NO donors.
Research Question: Does the usage of Nitroglycerine skin patch enhance cervical ripening and facilitate induction of labor by Dinoprostone?
Null hypothesis: Nitroglycerine skin patch does not cause advantage for ripening of the cervix nor facilitate the process of labor induction.
Alternative hypothesis : Nitroglycerine skin patch has favorable effect in enhancing cervical ripening and the outcome of induction of labor.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Nitroglycerin as Nitroderm TTSⓇ skin patch is applied on the upper chest alongside with regular induction of labor protocol ( 3gm/ 8 hours DinoprostoneⓇ vaginal tablet in the posterior vaginal fornix) |
|
| Group B | Placebo Comparator | Placebo patch is applied on the upper chest alongside with regular induction of labour protocol ( 3gm/ 8 hours DinoprostoneⓇ vaginal tablet in the posterior vaginal fornix) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroderm TTS | Drug | Transdermal nitroglycerin 5mg skin patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the cervical Bishop's score | progression of Bishop's score recorded twice during the induction of labor | 6,12,18 and 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Development of any fetal or maternal side effects | associated headache and nausea (for instance) are well-recognized side effects during the induction of labor | From the time of administration of medication, cases will be assessed every 6 hours till 24 hours after delivery at time of discharge |
| Need of Oxytocin to initiate uterine contractions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Prof. Abdel-Megeeed I. Abdel-Megeeed, Doctorate | Ain Shams University Maternity Hospital | Study Chair |
| Ahmed S. Abd El-Hamid, Doctorate | Ain Shams University Maternity Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AinShams University Maternity Hospital | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15916656 | Result | Sharma Y, Kumar S, Mittal S, Misra R, Dadhwal V. Evaluation of glyceryl trinitrate, misoprostol, and prostaglandin E2 gel for preinduction cervical ripening in term pregnancy. J Obstet Gynaecol Res. 2005 Jun;31(3):210-5. doi: 10.1111/j.1447-0756.2005.00271.x. | |
| 16580291 | Result | Nunes FP, Campos AP, Pedroso SR, Leite CF, Avillez TP, Rodrigues RD, Meirinho M. Intravaginal glyceryl trinitrate and dinoprostone for cervical ripening and induction of labor. Am J Obstet Gynecol. 2006 Apr;194(4):1022-6. doi: 10.1016/j.ajog.2005.10.814. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 4, 2017 | |
| Reset | Aug 8, 2018 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2017 | Oct 20, 2017 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2017 | Oct 20, 2017 | ICF_001.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 4, 2017 | Aug 8, 2018 |
| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dinoprostone | Drug | Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction |
|
|
Whether the case managed to initiate uterine contractions without the need to induce them with oxytocin |
| from time of patch administration up to 24 hours |
| 28599068 | Result | West HM, Jozwiak M, Dodd JM. Methods of term labour induction for women with a previous caesarean section. Cochrane Database Syst Rev. 2017 Jun 9;6(6):CD009792. doi: 10.1002/14651858.CD009792.pub3. |
| 21678363 | Result | Kelly AJ, Munson C, Minden L. Nitric oxide donors for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD006901. doi: 10.1002/14651858.CD006901.pub2. |
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |