Nitroglycerin Skin Patches for Facilitating Cervical Ripening: A Randomized Controlled Trial
NCT ID: NCT03320187
Last Updated: 2017-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2016-12-31
2017-09-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A
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)
Nitroderm TTS
Transdermal nitroglycerin 5mg skin patch
Dinoprostone
Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction
Group B
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)
Dinoprostone
Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction
Interventions
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Nitroderm TTS
Transdermal nitroglycerin 5mg skin patch
Dinoprostone
Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Cephalic presentation,
3. Bishop score less than 5,
4. Assuring fetal monitoring,
5. The mother does not have PROM,
Exclusion Criteria
2. Abnormal presentation,
3. Multiple pregnancy,
4. Non assuring fetal CTG,
5. Fetus more than 90th percentile of expected weight,
6. Previous maternal obstructed labor or previous cesarean section,
7. Maternal obstetric or medical complication,
8. Structural anomaly of the uterus
17 Years
35 Years
FEMALE
Yes
Sponsors
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Dr. Ahmed S. Abd El-Hameed
UNKNOWN
Prof. Abdel-Megeeed I. Abdel- Megeeed
UNKNOWN
Ain Shams Maternity Hospital
OTHER
Responsible Party
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Peter Nagy Aziz Hanna
Resident Physician
Principal Investigators
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Prof. Abdel-Megeeed I. Abdel-Megeeed, Doctorate
Role: STUDY_CHAIR
Ain Shams University Maternity Hospital
Ahmed S. Abd El-Hamid, Doctorate
Role: STUDY_DIRECTOR
Ain Shams University Maternity Hospital
Locations
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AinShams University Maternity Hospital
Cairo, , Egypt
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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OG MS27042017
Identifier Type: -
Identifier Source: org_study_id