Induction of Labor Affected Fetus / NewbornPhase 2/3NCT03320187
Nitroglycerin Skin Patches for Facilitating Cervical Ripening: A Randomized Controlled Trial
A Phase 2/3 study testing Nitroderm TTS and Dinoprostone in people with Induction of Labor Affected Fetus / Newborn, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Nitroderm TTS and Dinoprostone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2016to 21 Sep 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Singleton living full-term fetus.
- Cephalic presentation,
- Bishop score less than 5,
- Assuring fetal monitoring,
- The mother does not have PROM,
Who cannot join
- Expected fetal anomaly (eg. by ultrasound),
- Abnormal presentation,
- Multiple pregnancy,
- Non assuring fetal CTG,
- Fetus more than 90th percentile of expected weight,
- Previous maternal obstructed labor or previous cesarean section,
- Maternal obstetric or medical complication,
- Structural anomaly of the uterus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NITROGLYCERINE SKIN PATCH VS PLACEBO PATCH FOR ENHANCING CERVICAL RIPENING IN LABOR INDUCTION: A RANDOMIZED CONTROLLED TRIAL
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.
Read the detailed description
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.
- Being tested
- Nitroderm TTS, Dinoprostone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitroderm TTSDrug
Also called Nitroglycerin transdermal patch
Transdermal nitroglycerin 5mg skin patch
DinoprostoneDrug
Also called Prostaglandin E2 Analogue
Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Nitroderm TTS; Drug: Dinoprostone |
| 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) Receives: Drug: Dinoprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the cervical Bishop's score
progression of Bishop's score recorded twice during the induction of labor
Measured: 6,12,18 and 24 hours after administration
Secondary outcomes (2)
Development of any fetal or maternal side effects
associated headache and nausea (for instance) are well-recognized side effects during the induction of labor
Measured: 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
Whether the case managed to initiate uterine contractions without the need to induce them with oxytocin
Measured: from time of patch administration up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study startDec 2016
- Primary completionSep 2017
- Study completion21 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Ahmed S. Abd El-Hameed, Prof. Abdel-Megeeed I. Abdel- Megeeed
- Responsible party
- Principal investigator, Peter Nagy Aziz Hanna, Ain Shams Maternity Hospital
- Investigators
- Prof. Abdel-Megeeed I. Abdel-Megeeed, Doctorate, Study chair, Ain Shams University Maternity HospitalAhmed S. Abd El-Hamid, Doctorate, Study director, Ain Shams University Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320187
- Sponsor's protocol ID
- OG MS27042017
- Status last verified
- Oct 2017
- First submitted
- 22 Sep 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15916656Nunes 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.
PubMed 16580291West 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.
PubMed 28599068Kelly 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.
PubMed 21678363
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NITROGLYCERINE SKIN PATCH VS PLACEBO PATCH FOR ENHANCING CERVICAL RIPENING IN LABOR INDUCTION: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT03320187
- Acronym / sponsor ID
- OG MS27042017
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Collaborators
- Dr. Ahmed S. Abd El-Hameed, Prof. Abdel-Megeeed I. Abdel- Megeeed
- Study start
- Dec 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Nitroderm TTS, Drug: DinoprostoneNitroglycerin 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 | Drug: DinoprostonePlacebo 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) |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Singleton living full-term fetus.
- Cephalic presentation,
- Bishop score less than 5,
- Assuring fetal monitoring,
- The mother does not have PROM,
Key exclusion criteria (8 listed)
- Expected fetal anomaly (eg. by ultrasound),
- Abnormal presentation,
- Multiple pregnancy,
- Non assuring fetal CTG,
- Fetus more than 90th percentile of expected weight,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitroderm TTSAlso: Nitroglycerin transdermal patchTransdermal nitroglycerin 5mg skin patch | Drug | Group A |
| DinoprostoneAlso: Prostaglandin E2 AnalogueDinoprostone 3gm vaginal tablet will be used as the study method of labor induction | Drug | Group A, Group B |
Primary outcome
Changes in the cervical Bishop's score
Time frame: 6,12,18 and 24 hours after administration
progression of Bishop's score recorded twice during the induction of labor
2 secondary outcomes
Development of any fetal or maternal side effects
Time frame: 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
Time frame: from time of patch administration up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Results publication: PubMed 15916656Sharma 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.
- Results publication: PubMed 16580291Nunes 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.
- Results publication: PubMed 28599068West 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.
- Results publication: PubMed 21678363Kelly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Abdel-Megeeed I. Abdel-Megeeed, Doctorate study chair
Ain Shams University Maternity Hospital
Ahmed S. Abd El-Hamid, Doctorate study director
Ain Shams University Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nitroderm TTS and Dinoprostone in people with Induction of Labor Affected Fetus / Newborn, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the cervical Bishop's score (time frame: 6,12,18 and 24 hours after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03320187, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.